Obstetrics

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.

“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

One in five women in the United States undergoing maternity care experiences mistreatment from health care providers, based on survey data from more than 2,000 individuals.

“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.

Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.

Dr. Mohamoud

“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.

In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.

The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.

Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”

Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.

Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).

However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.

When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).

Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).

With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.

In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).

The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.

However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.

In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.

Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

A version of this article first appeared on Medscape.com.

TOPLINE:

More than 3.6 million women of reproductive age lack access to fertility clinics offering standard fertility preservation services before cancer treatment, a study shows.

METHODOLOGY:

• In this cross-sectional analysis, researchers identified 370 fertility centers in the United States (361 in the continental U.S.) that provide oncofertility services and that met criteria for an oncofertility center.
• Clinics were considered oncofertility centers if they offered oocyte cryopreservation, had performed at least one fertility preservation cycle in 2018, reported serving people without partners, and had an embryology laboratory that was accredited per Centers for Disease Control and Prevention guidelines.
• Researchers then quantified the number of young women potentially eligible for oncofertility services who lived farther than 2 hours from an oncofertility center.
• In a secondary analysis, the team assessed the association between geographic access and state fertility preservation insurance mandates.

TAKEAWAY:

• Overall, 3.63 million (5.7%) young women of reproductive age in the United States (aged 15-4) live more than 2 hours from an oncofertility center.
• The greatest gaps in access are in the Mountain West, West North Central, and Southwest regions; for instance, in Montana, North Dakota, and Wyoming fewer than half of the at-risk population has geographic access to an oncofertility center.
• Among the 11 states with fertility preservation insurance mandates, 98.5% of at-risk women have geographic access to an oncofertility center; in the 17 states without fertility preservation legislation, 79.6% of at-risk women have access to an oncofertility center.

IN PRACTICE:

Just over 3.6 million “reproductive-age female individuals lack geographic access to oncofertility services, especially in the Mountain West and West North Central regions,” the authors concluded. “Significant geographic disparities in access to fertility preservation in the U.S. require strategic expansion of care, especially given the growing demand for oncofertility services.”

SOURCE:

The study, led by Benjamin Peipert, MD, with Duke University, Durham, N.C., was published online in JAMA Oncology.

LIMITATIONS:

The authors relied on clinic data reported to the CDC, made assumptions about reasonable travel time, and may have underestimated access in some areas.

DISCLOSURES:

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

More than 3.6 million women of reproductive age lack access to fertility clinics offering standard fertility preservation services before cancer treatment, a study shows.

METHODOLOGY:

• In this cross-sectional analysis, researchers identified 370 fertility centers in the United States (361 in the continental U.S.) that provide oncofertility services and that met criteria for an oncofertility center.
• Clinics were considered oncofertility centers if they offered oocyte cryopreservation, had performed at least one fertility preservation cycle in 2018, reported serving people without partners, and had an embryology laboratory that was accredited per Centers for Disease Control and Prevention guidelines.
• Researchers then quantified the number of young women potentially eligible for oncofertility services who lived farther than 2 hours from an oncofertility center.
• In a secondary analysis, the team assessed the association between geographic access and state fertility preservation insurance mandates.

TAKEAWAY:

• Overall, 3.63 million (5.7%) young women of reproductive age in the United States (aged 15-4) live more than 2 hours from an oncofertility center.
• The greatest gaps in access are in the Mountain West, West North Central, and Southwest regions; for instance, in Montana, North Dakota, and Wyoming fewer than half of the at-risk population has geographic access to an oncofertility center.
• Among the 11 states with fertility preservation insurance mandates, 98.5% of at-risk women have geographic access to an oncofertility center; in the 17 states without fertility preservation legislation, 79.6% of at-risk women have access to an oncofertility center.

IN PRACTICE:

Just over 3.6 million “reproductive-age female individuals lack geographic access to oncofertility services, especially in the Mountain West and West North Central regions,” the authors concluded. “Significant geographic disparities in access to fertility preservation in the U.S. require strategic expansion of care, especially given the growing demand for oncofertility services.”

SOURCE:

The study, led by Benjamin Peipert, MD, with Duke University, Durham, N.C., was published online in JAMA Oncology.

LIMITATIONS:

The authors relied on clinic data reported to the CDC, made assumptions about reasonable travel time, and may have underestimated access in some areas.

DISCLOSURES:

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

More than 3.6 million women of reproductive age lack access to fertility clinics offering standard fertility preservation services before cancer treatment, a study shows.

METHODOLOGY:

• In this cross-sectional analysis, researchers identified 370 fertility centers in the United States (361 in the continental U.S.) that provide oncofertility services and that met criteria for an oncofertility center.
• Clinics were considered oncofertility centers if they offered oocyte cryopreservation, had performed at least one fertility preservation cycle in 2018, reported serving people without partners, and had an embryology laboratory that was accredited per Centers for Disease Control and Prevention guidelines.
• Researchers then quantified the number of young women potentially eligible for oncofertility services who lived farther than 2 hours from an oncofertility center.
• In a secondary analysis, the team assessed the association between geographic access and state fertility preservation insurance mandates.

TAKEAWAY:

• Overall, 3.63 million (5.7%) young women of reproductive age in the United States (aged 15-4) live more than 2 hours from an oncofertility center.
• The greatest gaps in access are in the Mountain West, West North Central, and Southwest regions; for instance, in Montana, North Dakota, and Wyoming fewer than half of the at-risk population has geographic access to an oncofertility center.
• Among the 11 states with fertility preservation insurance mandates, 98.5% of at-risk women have geographic access to an oncofertility center; in the 17 states without fertility preservation legislation, 79.6% of at-risk women have access to an oncofertility center.

IN PRACTICE:

Just over 3.6 million “reproductive-age female individuals lack geographic access to oncofertility services, especially in the Mountain West and West North Central regions,” the authors concluded. “Significant geographic disparities in access to fertility preservation in the U.S. require strategic expansion of care, especially given the growing demand for oncofertility services.”

SOURCE:

The study, led by Benjamin Peipert, MD, with Duke University, Durham, N.C., was published online in JAMA Oncology.

LIMITATIONS:

The authors relied on clinic data reported to the CDC, made assumptions about reasonable travel time, and may have underestimated access in some areas.

DISCLOSURES:

The study had no commercial funding. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments. PND has potential long-term adverse health complications for the mother, her partner, the infant, and the mother-infant dyad.

Courtesy Dr. Alison M. Heru

Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.¹ Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.

Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.

The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.²

The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
 

Family research

There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.

Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.

When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.³

A high-quality intimate relationship is protective for many illnesses and PND is no exception.⁴

Assessment

Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.

The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.⁵ This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.

• I have been able to laugh and see the funny side of things.
• I have looked forward with enjoyment to things.
• I have blamed myself unnecessarily when things went wrong.
• I have been anxious or worried for no good reason.
• I have felt scared or panicky for no good reason.
• Things have been getting to me.
• I have been so unhappy that I have had difficulty sleeping.
• I have felt sad or miserable.
• I have been so unhappy that I have been crying.
• The thought of harming myself has occurred to me.

A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.⁶

For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).⁷

Family therapy interventions

A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.

In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.⁸

Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:

• Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
• Conflict management.
• Problem-solving skills related to shared responsibility in infant care and household activities.

Intensive day program for mothers and babies

There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.⁹

The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.

The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.

A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.¹⁰

Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.

The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.¹¹

Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.

Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.

3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.

5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.

7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.

8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.

9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.

10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.

11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.

Beleaguered directors of obstetrics/gynecology residency programs may be relieved to know that a new application platform for all ob.gyn. residency applications is poised to come into effect for the 2024-25 cycle.

In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
 

Efficiencies and lower costs

Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.

courtesy Children’s Hospital of the King’s Daughters

“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”

A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
 

Holistic review

According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.

courtesy University of Michigan

“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.

So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.

For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”

An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.

Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.

“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.

courtesy ACOG

“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”

Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.

According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.

“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
 

AAMC strikes back

Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.

courtesy AAMC

“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”

Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
 

Evolution of specialty application

In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.

Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.

While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.

“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
 

Financial impact

Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.

But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.

“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”

Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.

Beleaguered directors of obstetrics/gynecology residency programs may be relieved to know that a new application platform for all ob.gyn. residency applications is poised to come into effect for the 2024-25 cycle.

In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
 

Efficiencies and lower costs

Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.

courtesy Children’s Hospital of the King’s Daughters

“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”

A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
 

Holistic review

According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.

courtesy University of Michigan

“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.

So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.

For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”

An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.

Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.

“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.

courtesy ACOG

“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”

Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.

According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.

“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
 

AAMC strikes back

Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.

courtesy AAMC

“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”

Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
 

Evolution of specialty application

In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.

Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.

While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.

“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
 

Financial impact

Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.

But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.

“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”

Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.

Beleaguered directors of obstetrics/gynecology residency programs may be relieved to know that a new application platform for all ob.gyn. residency applications is poised to come into effect for the 2024-25 cycle.

In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
 

Efficiencies and lower costs

Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.

courtesy Children’s Hospital of the King’s Daughters

“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”

A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
 

Holistic review

According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.

courtesy University of Michigan

“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.

So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.

For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”

An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.

Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.

“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.

courtesy ACOG

“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”

Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.

According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.

“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
 

AAMC strikes back

Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.

courtesy AAMC

“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”

Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
 

Evolution of specialty application

In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.

Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.

While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.

“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
 

Financial impact

Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.

But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.

“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”

Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

CASE Painful, heavy menstruation and recurrent pregnancy loss

A 37-year-old woman (G3P0030) with a history of recurrent pregnancy loss presents for evaluation. She had 3 losses—most recently a miscarriage at 22 weeks with a cerclage in place. She did not undergo any surgical procedures for these losses. Hormonal and thrombophilia workup is negative and semen analysis is normal. She reports a history of painful, heavy periods for many years, as well as dyspareunia and occasional post-coital bleeding. Past medical history was otherwise unremarkable. Pelvic magnetic resonance imaging (MRI) revealed focal thickening of the junctional zone up to 15 mm with 2 foci of T2 hyperintensities suggesting adenomyosis (FIGURE 1).

How do you counsel this patient regarding the MRI findings and their impact on her fertility?

Adenomyosis is a condition in which endometrial glands and stroma are abnormally present in the uterine myometrium, resulting in smooth muscle hypertrophy and abnormal uterine contractility. Traditional teaching describes a woman in her 40s with heavy and painful menses, a “boggy uterus” on examination, who has completed childbearing and desires definitive treatment. Histologic diagnosis of adenomyosis is made from the uterine specimen at the time of hysterectomy, invariably confounding our understanding of the epidemiology of adenomyosis.

More recently, however, we are beginning to learn that this narrative is misguided. Imaging changes of adenomyosis can be seen in women who desire future fertility and in adolescents with severe dysmenorrhea, suggesting an earlier age of incidence.¹ In a recent systematic review, prevalence estimates ranged from 15% to 67%, owing to varying diagnostic methods and patient inclusion criteria.² It is increasingly being recognized as a primary contributor to infertility, with one study estimating a 30% prevalence of infertility in women with adenomyosis.³ Moreover, treatment with gonadotropin-releasing hormone agonists and/or surgical excision may improve fertility outcomes.⁴

As we learn more about this prevalent and life-altering condition, we owe it to our patients to consider this diagnosis when counseling on dysmenorrhea, heavy menstrual bleeding, or infertility.

Anatomy of the myometrium

The myometrium is composed of the inner and outer myometrium: the inner myometrium (IM) and endometrium are of Müllerian origin, and the outer myometrium (OM) is of mesenchymal origin. The IM thickens in response to steroid hormones during the menstrual cycle with metaplasia of endometrial stromal cells into myocytes and back again, whereas the OM is not responsive to hormones.⁵ Emerging literature suggests the OM is further divided into a middle and outer section based on different histologic morphologies, though the clinical implications of this are not understood.⁶ The term “junctional zone” (JZ) refers to the imaging appearance of what is thought to be the IM. Interestingly it cannot be identified on traditional hematoxylin and eosin staining. When the JZ is thickened or demonstrates irregular borders, it is used as a diagnostic marker for adenomyosis and is postulated to play an important role in adenomyosis pathophysiology, particularly heavy menstrual bleeding and infertility.⁷

Continue to: Subtypes of adenomyosis...

Subtypes of adenomyosis

While various disease classifications have been suggested for adenomyosis, to date there is no international consensus. Adenomyosis is typically described in 3 forms: diffuse, focal, or adenomyoma.⁸ As implied, the term focal adenomyosis refers to discrete lesions surrounded by normal myometrium, whereas abnormal glandular changes are pervasive throughout the myometrium in diffuse disease. Adenomyomas are a subgroup of focal adenomyosis that are thought to be surrounded by leiomyomatous smooth muscle and may be well demarcated on imaging.⁹

Recent research uses novel histologic imaging techniques to explore adenomyotic growth patterns in 3-dimensional (3D) reconstructions. Combining tissue-clearing methods with light-sheet fluorescence microscopy enables highly detailed 3D representations of the protein and nucleic acid structure of organs.¹⁰ For example, Yamaguchi and colleagues used this technology to explore the 3D morphological features of adenomyotic tissue and observed direct invasion of the endometrial glands into the myometrium and an “ant colony ̶ like network” of ectopic endometrial glands in the myometrium (FIGURE 2).¹¹ These abnormal glandular networks have been visualized beyond the IM, which may not be captured on ultrasonography or MRI. While this work is still in its infancy, it has the potential to provide important insight into disease pathogenesis and to inform future therapy.

Pathogenesis

Proposed mechanisms for the development of adenomyosis include endometrial invasion, tissue injury and repair (TIAR) mechanisms, and the stem cell theory.¹² According to the endometrial invasion theory, glandular epithelial cells from the basalis layer invaginate through an altered IM, slipping through weak muscle fibers and attracted by certain growth factors. In the TIAR mechanism theory, micro- or macro-trauma to the IM (whether from pregnancy, surgery, or infection) results in chronic proliferation and inflammation leading to the development of adenomyosis. Finally, the stem cell theory proposes that adenomyosis might develop from de novo ectopic endometrial tissue.

While the exact pathogenesis of adenomyosis is largely unknown, it has been associated with predictable molecular changes in the endometrium and surrounding myometrium.¹² Myometrial hypercontractility is seen in patients with adenomyosis and dysmenorrhea, whereas neovascularization, high microvessel density, and abnormal uterine contractility are seen in those with abnormal uterine bleeding.¹³ In patients with infertility, increased inflammation, abnormal endometrial receptivity, and alterations in the myometrial architecture have been suggested to impair contractility and sperm transport.^12,14

Differential growth factor expression and abnormal estrogen and progesterone signaling pathways have been observed in the IM in patients with adenomyosis, along with dysregulation of immune factors and increased inflammatory oxidative stress.¹² This in turn results in myometrial hypertrophy and fibrosis, impairing normal uterine contractility patterns. This abnormal contractility may alter sperm transport and embryo implantation, and animal models that target pathways leading to fibrosis may improve endometrial receptivity.^14,15 Further research is needed to elucidate specific molecular pathways and their complex interplay in this disease.

Continue to: Diagnosis...

The gold standard for diagnosis of adenomyosis is histopathology from hysterectomy specimens, but specific definitions vary. Published criteria include endometrial glands within the myometrial layer greater than 0.5 to 1 low power field from the basal layer of the endometrium, endometrial glands extending deeper than 25% of the myometrial thickness, or endometrial glands a certain distance (ranging from 1-3 mm) from the basalis layer of the endometrium.¹⁶ Various methods of non-hysterectomy tissue sampling have been proposed for diagnosis, including needle, hysteroscopic, or laparoscopic sampling, but the sensitivity of these methods is poor.¹⁷ Limiting the diagnosis of adenomyosis to specimen pathology relies on invasive methods and clearly we cannot confirm the diagnosis by hysterectomy in patients with a desire for future fertility. It is for this reason that the prevalence of the disease is widely unknown.

The alternative to pathologic diagnosis is to identify radiologic changes that are associated with adenomyosis via either transvaginal ultrasound (TVUS) or MRI. Features suggestive of adenomyosis on MRI overlap with TVUS features, including uterine enlargement, anteroposterior myometrial asymmetry, T1- or T2-intense myometrial cysts or foci, and a thickened JZ.¹⁸ A JZ thicker than 12 mm has been thought to be predictive of adenomyosis, whereas a thickness of less than 8 mm is predictive of its absence, although the JZ may vary in thickness with the menstrual cycle.^19,20 A 2021 systematic review and meta-analysis comparing MRI diagnosis with histopathologic findings reported a pooled sensitivity and specificity of 60% and 96%, respectively.²¹ The reported range for sensitivity and specificity is wide: 70% to 93% for sensitivity and 67% to 93% for specificity.^22-24

Key TVUS features associated with adenomyosis were defined in 2015 in a consensus statement released by the Morphological Uterus Sonographic Assessment (MUSA) group.²⁵ These include a globally enlarged uterus, anteroposterior myometrial asymmetry, myometrial cysts, fan-shaped shadowing, mixed myometrial echogenicity, translesional vascularity, echogenic subendometrial lines and buds, and a thickened, irregular or discontinuous JZ (FIGURES 3 and 4).²⁵ The accuracy of ultrasonographic diagnosis of adenomyosis using these features has been investigated in multiple systematic reviews and meta-analyses, most recently by Liu and colleagues who found a pooled sensitivity of TVUS of 81% and pooled specificity of 87%.²³ The range for ultrasonographic sensitivity and specificity is wide, however, ranging from 33% to 84% for sensitivity and 64% to 100% for specificity.²² Consensus is lacking as to which TVUS features are most predictive of adenomyosis, but in general, the combination of multiple MUSA criteria (particularly myometrial cysts and irregular JZ on 3D imaging) appears to be more accurate than any one feature alone.²³ The presence of fibroids may decrease the sensitivity of TVUS, and one study suggested elastography may increase the accuracy of TVUS.^24,26 Moreover, given that most radiologists receive limited training on the MUSA criteria, it behooves gynecologists to become familiar with these sonographic features to be able to identify adenomyosis in our patients.

Clinical presentation

While many women who are later diagnosed with adenomyosis are asymptomatic, the disease can present with heavy menstrual bleeding and dysmenorrhea, which occur in 50% and 30% of patients, respectively.²⁸ Other symptoms include dyspareunia and infertility. Symptoms were previously reported to develop between the ages of 40 and 50 years; however, this is biased by diagnosis at the time of hysterectomy and the fact that younger patients are less likely to undergo definitive surgery. When using imaging criteria for diagnosis, adenomyosis might be more responsible for dysmenorrhea and chronic pelvic pain in younger patients than previously appreciated.^1,29 In a recent study reviewing TVUS in 270 adolescents for any reason, adenomyosis was present in 5% of cases and this increased up to 44% in the presence of endometriosis.³⁰

Adenomyosis often co-exists and shares similar clinical presentations with other gynecologic pathologies such as endometriosis and fibroids, making diagnosis on symptomatology alone challenging. Concurrent adenomyosis has been found in up to 73% and 57% of patients with suspected or diagnosed endometriosis and fibroids, respectively.^31,32 Accumulating evidence suggests that pelvic pain previously attributed to endometriosis may in fact be a result of adenomyosis; for example, persistent pelvic pain after optimal resection of endometriosis may be confounded by the presence of adenomyosis.²⁹ In one study of 155 patients with complete resection of deep infiltrating endometriosis, persistent pelvic pain was significantly associated with the presence of adenomyosis on imaging.³³

Adenomyosis is increasingly being recognized at the time of infertility evaluation with an estimated prevalence of 30% in women with infertility.³ Among women with infertility, adenomyosis has been associated with a lower clinical pregnancy rate, higher miscarriage rate, and lower live birth rate, as well as obstetric complications such as abnormal placentation.^34-36 A study of 37 baboons found the histologic diagnosis of adenomyosis alone at necropsy was associated with a 20-fold increased risk of lifelong infertility (odds ratio [OR], 20.1; 95% CI, 2.1-921), whereas presence of endometriosis was associated with a nonsignificant 3-fold risk of lifelong infertility (OR, 3.6; 95% CI, 0.9-15.8).³⁷

In women with endometriosis and infertility, co-existing adenomyosis portends worse fertility outcomes. In a retrospective study of 244 women who underwent endometriosis surgery, more than five features of adenomyosis on imaging was associated with higher rates of infertility, in vitro fertilization treatments, and a higher number of in vitro fertilization cycles.³¹ Moreover, in women who underwent surgery for deep infiltrating endometriosis, the presence of adenomyosis on imaging was associated with a 68% reduction in likelihood of pregnancy after surgery.³⁸

Conclusion

As we begin to learn about adenomyosis, our misconceptions become more evident. The notion that it largely affects women at the end of their reproductive lives is biased by using histopathology at hysterectomy as the gold standard for diagnosis. Lack of definitive histologic or imaging criteria and biopsy techniques add to the diagnostic challenge. This in turn leads to inaccurate estimates of incidence and prevalence, as we assume patients’ symptoms must be attributable to what we can see at the time of surgery (for example, Stage I or II endometriosis), rather than what we cannot see. We now know that adenomyosis is present in women of all ages, including adolescents, and can significantly contribute to reduced fertility and quality of life. We owe it to our patients to consider this condition in the differential diagnosis of dysmenorrhea, heavy menstrual bleeding, dyspareunia, and infertility.

CASE Resolved

The patient underwent targeted hysteroscopic resection of adenomyosis (FIGURE 5) and conceived spontaneously the following year. ●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

CASE Painful, heavy menstruation and recurrent pregnancy loss

A 37-year-old woman (G3P0030) with a history of recurrent pregnancy loss presents for evaluation. She had 3 losses—most recently a miscarriage at 22 weeks with a cerclage in place. She did not undergo any surgical procedures for these losses. Hormonal and thrombophilia workup is negative and semen analysis is normal. She reports a history of painful, heavy periods for many years, as well as dyspareunia and occasional post-coital bleeding. Past medical history was otherwise unremarkable. Pelvic magnetic resonance imaging (MRI) revealed focal thickening of the junctional zone up to 15 mm with 2 foci of T2 hyperintensities suggesting adenomyosis (FIGURE 1).

How do you counsel this patient regarding the MRI findings and their impact on her fertility?

Adenomyosis is a condition in which endometrial glands and stroma are abnormally present in the uterine myometrium, resulting in smooth muscle hypertrophy and abnormal uterine contractility. Traditional teaching describes a woman in her 40s with heavy and painful menses, a “boggy uterus” on examination, who has completed childbearing and desires definitive treatment. Histologic diagnosis of adenomyosis is made from the uterine specimen at the time of hysterectomy, invariably confounding our understanding of the epidemiology of adenomyosis.

More recently, however, we are beginning to learn that this narrative is misguided. Imaging changes of adenomyosis can be seen in women who desire future fertility and in adolescents with severe dysmenorrhea, suggesting an earlier age of incidence.¹ In a recent systematic review, prevalence estimates ranged from 15% to 67%, owing to varying diagnostic methods and patient inclusion criteria.² It is increasingly being recognized as a primary contributor to infertility, with one study estimating a 30% prevalence of infertility in women with adenomyosis.³ Moreover, treatment with gonadotropin-releasing hormone agonists and/or surgical excision may improve fertility outcomes.⁴

As we learn more about this prevalent and life-altering condition, we owe it to our patients to consider this diagnosis when counseling on dysmenorrhea, heavy menstrual bleeding, or infertility.

Anatomy of the myometrium

The myometrium is composed of the inner and outer myometrium: the inner myometrium (IM) and endometrium are of Müllerian origin, and the outer myometrium (OM) is of mesenchymal origin. The IM thickens in response to steroid hormones during the menstrual cycle with metaplasia of endometrial stromal cells into myocytes and back again, whereas the OM is not responsive to hormones.⁵ Emerging literature suggests the OM is further divided into a middle and outer section based on different histologic morphologies, though the clinical implications of this are not understood.⁶ The term “junctional zone” (JZ) refers to the imaging appearance of what is thought to be the IM. Interestingly it cannot be identified on traditional hematoxylin and eosin staining. When the JZ is thickened or demonstrates irregular borders, it is used as a diagnostic marker for adenomyosis and is postulated to play an important role in adenomyosis pathophysiology, particularly heavy menstrual bleeding and infertility.⁷

Continue to: Subtypes of adenomyosis...

Subtypes of adenomyosis

While various disease classifications have been suggested for adenomyosis, to date there is no international consensus. Adenomyosis is typically described in 3 forms: diffuse, focal, or adenomyoma.⁸ As implied, the term focal adenomyosis refers to discrete lesions surrounded by normal myometrium, whereas abnormal glandular changes are pervasive throughout the myometrium in diffuse disease. Adenomyomas are a subgroup of focal adenomyosis that are thought to be surrounded by leiomyomatous smooth muscle and may be well demarcated on imaging.⁹

Recent research uses novel histologic imaging techniques to explore adenomyotic growth patterns in 3-dimensional (3D) reconstructions. Combining tissue-clearing methods with light-sheet fluorescence microscopy enables highly detailed 3D representations of the protein and nucleic acid structure of organs.¹⁰ For example, Yamaguchi and colleagues used this technology to explore the 3D morphological features of adenomyotic tissue and observed direct invasion of the endometrial glands into the myometrium and an “ant colony ̶ like network” of ectopic endometrial glands in the myometrium (FIGURE 2).¹¹ These abnormal glandular networks have been visualized beyond the IM, which may not be captured on ultrasonography or MRI. While this work is still in its infancy, it has the potential to provide important insight into disease pathogenesis and to inform future therapy.

Pathogenesis

Proposed mechanisms for the development of adenomyosis include endometrial invasion, tissue injury and repair (TIAR) mechanisms, and the stem cell theory.¹² According to the endometrial invasion theory, glandular epithelial cells from the basalis layer invaginate through an altered IM, slipping through weak muscle fibers and attracted by certain growth factors. In the TIAR mechanism theory, micro- or macro-trauma to the IM (whether from pregnancy, surgery, or infection) results in chronic proliferation and inflammation leading to the development of adenomyosis. Finally, the stem cell theory proposes that adenomyosis might develop from de novo ectopic endometrial tissue.

While the exact pathogenesis of adenomyosis is largely unknown, it has been associated with predictable molecular changes in the endometrium and surrounding myometrium.¹² Myometrial hypercontractility is seen in patients with adenomyosis and dysmenorrhea, whereas neovascularization, high microvessel density, and abnormal uterine contractility are seen in those with abnormal uterine bleeding.¹³ In patients with infertility, increased inflammation, abnormal endometrial receptivity, and alterations in the myometrial architecture have been suggested to impair contractility and sperm transport.^12,14

Differential growth factor expression and abnormal estrogen and progesterone signaling pathways have been observed in the IM in patients with adenomyosis, along with dysregulation of immune factors and increased inflammatory oxidative stress.¹² This in turn results in myometrial hypertrophy and fibrosis, impairing normal uterine contractility patterns. This abnormal contractility may alter sperm transport and embryo implantation, and animal models that target pathways leading to fibrosis may improve endometrial receptivity.^14,15 Further research is needed to elucidate specific molecular pathways and their complex interplay in this disease.

Continue to: Diagnosis...

The gold standard for diagnosis of adenomyosis is histopathology from hysterectomy specimens, but specific definitions vary. Published criteria include endometrial glands within the myometrial layer greater than 0.5 to 1 low power field from the basal layer of the endometrium, endometrial glands extending deeper than 25% of the myometrial thickness, or endometrial glands a certain distance (ranging from 1-3 mm) from the basalis layer of the endometrium.¹⁶ Various methods of non-hysterectomy tissue sampling have been proposed for diagnosis, including needle, hysteroscopic, or laparoscopic sampling, but the sensitivity of these methods is poor.¹⁷ Limiting the diagnosis of adenomyosis to specimen pathology relies on invasive methods and clearly we cannot confirm the diagnosis by hysterectomy in patients with a desire for future fertility. It is for this reason that the prevalence of the disease is widely unknown.

The alternative to pathologic diagnosis is to identify radiologic changes that are associated with adenomyosis via either transvaginal ultrasound (TVUS) or MRI. Features suggestive of adenomyosis on MRI overlap with TVUS features, including uterine enlargement, anteroposterior myometrial asymmetry, T1- or T2-intense myometrial cysts or foci, and a thickened JZ.¹⁸ A JZ thicker than 12 mm has been thought to be predictive of adenomyosis, whereas a thickness of less than 8 mm is predictive of its absence, although the JZ may vary in thickness with the menstrual cycle.^19,20 A 2021 systematic review and meta-analysis comparing MRI diagnosis with histopathologic findings reported a pooled sensitivity and specificity of 60% and 96%, respectively.²¹ The reported range for sensitivity and specificity is wide: 70% to 93% for sensitivity and 67% to 93% for specificity.^22-24

Key TVUS features associated with adenomyosis were defined in 2015 in a consensus statement released by the Morphological Uterus Sonographic Assessment (MUSA) group.²⁵ These include a globally enlarged uterus, anteroposterior myometrial asymmetry, myometrial cysts, fan-shaped shadowing, mixed myometrial echogenicity, translesional vascularity, echogenic subendometrial lines and buds, and a thickened, irregular or discontinuous JZ (FIGURES 3 and 4).²⁵ The accuracy of ultrasonographic diagnosis of adenomyosis using these features has been investigated in multiple systematic reviews and meta-analyses, most recently by Liu and colleagues who found a pooled sensitivity of TVUS of 81% and pooled specificity of 87%.²³ The range for ultrasonographic sensitivity and specificity is wide, however, ranging from 33% to 84% for sensitivity and 64% to 100% for specificity.²² Consensus is lacking as to which TVUS features are most predictive of adenomyosis, but in general, the combination of multiple MUSA criteria (particularly myometrial cysts and irregular JZ on 3D imaging) appears to be more accurate than any one feature alone.²³ The presence of fibroids may decrease the sensitivity of TVUS, and one study suggested elastography may increase the accuracy of TVUS.^24,26 Moreover, given that most radiologists receive limited training on the MUSA criteria, it behooves gynecologists to become familiar with these sonographic features to be able to identify adenomyosis in our patients.

Clinical presentation

While many women who are later diagnosed with adenomyosis are asymptomatic, the disease can present with heavy menstrual bleeding and dysmenorrhea, which occur in 50% and 30% of patients, respectively.²⁸ Other symptoms include dyspareunia and infertility. Symptoms were previously reported to develop between the ages of 40 and 50 years; however, this is biased by diagnosis at the time of hysterectomy and the fact that younger patients are less likely to undergo definitive surgery. When using imaging criteria for diagnosis, adenomyosis might be more responsible for dysmenorrhea and chronic pelvic pain in younger patients than previously appreciated.^1,29 In a recent study reviewing TVUS in 270 adolescents for any reason, adenomyosis was present in 5% of cases and this increased up to 44% in the presence of endometriosis.³⁰

Adenomyosis often co-exists and shares similar clinical presentations with other gynecologic pathologies such as endometriosis and fibroids, making diagnosis on symptomatology alone challenging. Concurrent adenomyosis has been found in up to 73% and 57% of patients with suspected or diagnosed endometriosis and fibroids, respectively.^31,32 Accumulating evidence suggests that pelvic pain previously attributed to endometriosis may in fact be a result of adenomyosis; for example, persistent pelvic pain after optimal resection of endometriosis may be confounded by the presence of adenomyosis.²⁹ In one study of 155 patients with complete resection of deep infiltrating endometriosis, persistent pelvic pain was significantly associated with the presence of adenomyosis on imaging.³³

Adenomyosis is increasingly being recognized at the time of infertility evaluation with an estimated prevalence of 30% in women with infertility.³ Among women with infertility, adenomyosis has been associated with a lower clinical pregnancy rate, higher miscarriage rate, and lower live birth rate, as well as obstetric complications such as abnormal placentation.^34-36 A study of 37 baboons found the histologic diagnosis of adenomyosis alone at necropsy was associated with a 20-fold increased risk of lifelong infertility (odds ratio [OR], 20.1; 95% CI, 2.1-921), whereas presence of endometriosis was associated with a nonsignificant 3-fold risk of lifelong infertility (OR, 3.6; 95% CI, 0.9-15.8).³⁷

In women with endometriosis and infertility, co-existing adenomyosis portends worse fertility outcomes. In a retrospective study of 244 women who underwent endometriosis surgery, more than five features of adenomyosis on imaging was associated with higher rates of infertility, in vitro fertilization treatments, and a higher number of in vitro fertilization cycles.³¹ Moreover, in women who underwent surgery for deep infiltrating endometriosis, the presence of adenomyosis on imaging was associated with a 68% reduction in likelihood of pregnancy after surgery.³⁸

Conclusion

As we begin to learn about adenomyosis, our misconceptions become more evident. The notion that it largely affects women at the end of their reproductive lives is biased by using histopathology at hysterectomy as the gold standard for diagnosis. Lack of definitive histologic or imaging criteria and biopsy techniques add to the diagnostic challenge. This in turn leads to inaccurate estimates of incidence and prevalence, as we assume patients’ symptoms must be attributable to what we can see at the time of surgery (for example, Stage I or II endometriosis), rather than what we cannot see. We now know that adenomyosis is present in women of all ages, including adolescents, and can significantly contribute to reduced fertility and quality of life. We owe it to our patients to consider this condition in the differential diagnosis of dysmenorrhea, heavy menstrual bleeding, dyspareunia, and infertility.

CASE Resolved

The patient underwent targeted hysteroscopic resection of adenomyosis (FIGURE 5) and conceived spontaneously the following year. ●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

CASE Painful, heavy menstruation and recurrent pregnancy loss

A 37-year-old woman (G3P0030) with a history of recurrent pregnancy loss presents for evaluation. She had 3 losses—most recently a miscarriage at 22 weeks with a cerclage in place. She did not undergo any surgical procedures for these losses. Hormonal and thrombophilia workup is negative and semen analysis is normal. She reports a history of painful, heavy periods for many years, as well as dyspareunia and occasional post-coital bleeding. Past medical history was otherwise unremarkable. Pelvic magnetic resonance imaging (MRI) revealed focal thickening of the junctional zone up to 15 mm with 2 foci of T2 hyperintensities suggesting adenomyosis (FIGURE 1).

How do you counsel this patient regarding the MRI findings and their impact on her fertility?

Adenomyosis is a condition in which endometrial glands and stroma are abnormally present in the uterine myometrium, resulting in smooth muscle hypertrophy and abnormal uterine contractility. Traditional teaching describes a woman in her 40s with heavy and painful menses, a “boggy uterus” on examination, who has completed childbearing and desires definitive treatment. Histologic diagnosis of adenomyosis is made from the uterine specimen at the time of hysterectomy, invariably confounding our understanding of the epidemiology of adenomyosis.

More recently, however, we are beginning to learn that this narrative is misguided. Imaging changes of adenomyosis can be seen in women who desire future fertility and in adolescents with severe dysmenorrhea, suggesting an earlier age of incidence.¹ In a recent systematic review, prevalence estimates ranged from 15% to 67%, owing to varying diagnostic methods and patient inclusion criteria.² It is increasingly being recognized as a primary contributor to infertility, with one study estimating a 30% prevalence of infertility in women with adenomyosis.³ Moreover, treatment with gonadotropin-releasing hormone agonists and/or surgical excision may improve fertility outcomes.⁴

As we learn more about this prevalent and life-altering condition, we owe it to our patients to consider this diagnosis when counseling on dysmenorrhea, heavy menstrual bleeding, or infertility.

Anatomy of the myometrium

The myometrium is composed of the inner and outer myometrium: the inner myometrium (IM) and endometrium are of Müllerian origin, and the outer myometrium (OM) is of mesenchymal origin. The IM thickens in response to steroid hormones during the menstrual cycle with metaplasia of endometrial stromal cells into myocytes and back again, whereas the OM is not responsive to hormones.⁵ Emerging literature suggests the OM is further divided into a middle and outer section based on different histologic morphologies, though the clinical implications of this are not understood.⁶ The term “junctional zone” (JZ) refers to the imaging appearance of what is thought to be the IM. Interestingly it cannot be identified on traditional hematoxylin and eosin staining. When the JZ is thickened or demonstrates irregular borders, it is used as a diagnostic marker for adenomyosis and is postulated to play an important role in adenomyosis pathophysiology, particularly heavy menstrual bleeding and infertility.⁷

Continue to: Subtypes of adenomyosis...

Subtypes of adenomyosis

While various disease classifications have been suggested for adenomyosis, to date there is no international consensus. Adenomyosis is typically described in 3 forms: diffuse, focal, or adenomyoma.⁸ As implied, the term focal adenomyosis refers to discrete lesions surrounded by normal myometrium, whereas abnormal glandular changes are pervasive throughout the myometrium in diffuse disease. Adenomyomas are a subgroup of focal adenomyosis that are thought to be surrounded by leiomyomatous smooth muscle and may be well demarcated on imaging.⁹

Recent research uses novel histologic imaging techniques to explore adenomyotic growth patterns in 3-dimensional (3D) reconstructions. Combining tissue-clearing methods with light-sheet fluorescence microscopy enables highly detailed 3D representations of the protein and nucleic acid structure of organs.¹⁰ For example, Yamaguchi and colleagues used this technology to explore the 3D morphological features of adenomyotic tissue and observed direct invasion of the endometrial glands into the myometrium and an “ant colony ̶ like network” of ectopic endometrial glands in the myometrium (FIGURE 2).¹¹ These abnormal glandular networks have been visualized beyond the IM, which may not be captured on ultrasonography or MRI. While this work is still in its infancy, it has the potential to provide important insight into disease pathogenesis and to inform future therapy.

Pathogenesis

Proposed mechanisms for the development of adenomyosis include endometrial invasion, tissue injury and repair (TIAR) mechanisms, and the stem cell theory.¹² According to the endometrial invasion theory, glandular epithelial cells from the basalis layer invaginate through an altered IM, slipping through weak muscle fibers and attracted by certain growth factors. In the TIAR mechanism theory, micro- or macro-trauma to the IM (whether from pregnancy, surgery, or infection) results in chronic proliferation and inflammation leading to the development of adenomyosis. Finally, the stem cell theory proposes that adenomyosis might develop from de novo ectopic endometrial tissue.

While the exact pathogenesis of adenomyosis is largely unknown, it has been associated with predictable molecular changes in the endometrium and surrounding myometrium.¹² Myometrial hypercontractility is seen in patients with adenomyosis and dysmenorrhea, whereas neovascularization, high microvessel density, and abnormal uterine contractility are seen in those with abnormal uterine bleeding.¹³ In patients with infertility, increased inflammation, abnormal endometrial receptivity, and alterations in the myometrial architecture have been suggested to impair contractility and sperm transport.^12,14

Differential growth factor expression and abnormal estrogen and progesterone signaling pathways have been observed in the IM in patients with adenomyosis, along with dysregulation of immune factors and increased inflammatory oxidative stress.¹² This in turn results in myometrial hypertrophy and fibrosis, impairing normal uterine contractility patterns. This abnormal contractility may alter sperm transport and embryo implantation, and animal models that target pathways leading to fibrosis may improve endometrial receptivity.^14,15 Further research is needed to elucidate specific molecular pathways and their complex interplay in this disease.

Continue to: Diagnosis...

The gold standard for diagnosis of adenomyosis is histopathology from hysterectomy specimens, but specific definitions vary. Published criteria include endometrial glands within the myometrial layer greater than 0.5 to 1 low power field from the basal layer of the endometrium, endometrial glands extending deeper than 25% of the myometrial thickness, or endometrial glands a certain distance (ranging from 1-3 mm) from the basalis layer of the endometrium.¹⁶ Various methods of non-hysterectomy tissue sampling have been proposed for diagnosis, including needle, hysteroscopic, or laparoscopic sampling, but the sensitivity of these methods is poor.¹⁷ Limiting the diagnosis of adenomyosis to specimen pathology relies on invasive methods and clearly we cannot confirm the diagnosis by hysterectomy in patients with a desire for future fertility. It is for this reason that the prevalence of the disease is widely unknown.

The alternative to pathologic diagnosis is to identify radiologic changes that are associated with adenomyosis via either transvaginal ultrasound (TVUS) or MRI. Features suggestive of adenomyosis on MRI overlap with TVUS features, including uterine enlargement, anteroposterior myometrial asymmetry, T1- or T2-intense myometrial cysts or foci, and a thickened JZ.¹⁸ A JZ thicker than 12 mm has been thought to be predictive of adenomyosis, whereas a thickness of less than 8 mm is predictive of its absence, although the JZ may vary in thickness with the menstrual cycle.^19,20 A 2021 systematic review and meta-analysis comparing MRI diagnosis with histopathologic findings reported a pooled sensitivity and specificity of 60% and 96%, respectively.²¹ The reported range for sensitivity and specificity is wide: 70% to 93% for sensitivity and 67% to 93% for specificity.^22-24

Key TVUS features associated with adenomyosis were defined in 2015 in a consensus statement released by the Morphological Uterus Sonographic Assessment (MUSA) group.²⁵ These include a globally enlarged uterus, anteroposterior myometrial asymmetry, myometrial cysts, fan-shaped shadowing, mixed myometrial echogenicity, translesional vascularity, echogenic subendometrial lines and buds, and a thickened, irregular or discontinuous JZ (FIGURES 3 and 4).²⁵ The accuracy of ultrasonographic diagnosis of adenomyosis using these features has been investigated in multiple systematic reviews and meta-analyses, most recently by Liu and colleagues who found a pooled sensitivity of TVUS of 81% and pooled specificity of 87%.²³ The range for ultrasonographic sensitivity and specificity is wide, however, ranging from 33% to 84% for sensitivity and 64% to 100% for specificity.²² Consensus is lacking as to which TVUS features are most predictive of adenomyosis, but in general, the combination of multiple MUSA criteria (particularly myometrial cysts and irregular JZ on 3D imaging) appears to be more accurate than any one feature alone.²³ The presence of fibroids may decrease the sensitivity of TVUS, and one study suggested elastography may increase the accuracy of TVUS.^24,26 Moreover, given that most radiologists receive limited training on the MUSA criteria, it behooves gynecologists to become familiar with these sonographic features to be able to identify adenomyosis in our patients.

Clinical presentation

While many women who are later diagnosed with adenomyosis are asymptomatic, the disease can present with heavy menstrual bleeding and dysmenorrhea, which occur in 50% and 30% of patients, respectively.²⁸ Other symptoms include dyspareunia and infertility. Symptoms were previously reported to develop between the ages of 40 and 50 years; however, this is biased by diagnosis at the time of hysterectomy and the fact that younger patients are less likely to undergo definitive surgery. When using imaging criteria for diagnosis, adenomyosis might be more responsible for dysmenorrhea and chronic pelvic pain in younger patients than previously appreciated.^1,29 In a recent study reviewing TVUS in 270 adolescents for any reason, adenomyosis was present in 5% of cases and this increased up to 44% in the presence of endometriosis.³⁰

Adenomyosis often co-exists and shares similar clinical presentations with other gynecologic pathologies such as endometriosis and fibroids, making diagnosis on symptomatology alone challenging. Concurrent adenomyosis has been found in up to 73% and 57% of patients with suspected or diagnosed endometriosis and fibroids, respectively.^31,32 Accumulating evidence suggests that pelvic pain previously attributed to endometriosis may in fact be a result of adenomyosis; for example, persistent pelvic pain after optimal resection of endometriosis may be confounded by the presence of adenomyosis.²⁹ In one study of 155 patients with complete resection of deep infiltrating endometriosis, persistent pelvic pain was significantly associated with the presence of adenomyosis on imaging.³³

Adenomyosis is increasingly being recognized at the time of infertility evaluation with an estimated prevalence of 30% in women with infertility.³ Among women with infertility, adenomyosis has been associated with a lower clinical pregnancy rate, higher miscarriage rate, and lower live birth rate, as well as obstetric complications such as abnormal placentation.^34-36 A study of 37 baboons found the histologic diagnosis of adenomyosis alone at necropsy was associated with a 20-fold increased risk of lifelong infertility (odds ratio [OR], 20.1; 95% CI, 2.1-921), whereas presence of endometriosis was associated with a nonsignificant 3-fold risk of lifelong infertility (OR, 3.6; 95% CI, 0.9-15.8).³⁷

In women with endometriosis and infertility, co-existing adenomyosis portends worse fertility outcomes. In a retrospective study of 244 women who underwent endometriosis surgery, more than five features of adenomyosis on imaging was associated with higher rates of infertility, in vitro fertilization treatments, and a higher number of in vitro fertilization cycles.³¹ Moreover, in women who underwent surgery for deep infiltrating endometriosis, the presence of adenomyosis on imaging was associated with a 68% reduction in likelihood of pregnancy after surgery.³⁸

Conclusion

As we begin to learn about adenomyosis, our misconceptions become more evident. The notion that it largely affects women at the end of their reproductive lives is biased by using histopathology at hysterectomy as the gold standard for diagnosis. Lack of definitive histologic or imaging criteria and biopsy techniques add to the diagnostic challenge. This in turn leads to inaccurate estimates of incidence and prevalence, as we assume patients’ symptoms must be attributable to what we can see at the time of surgery (for example, Stage I or II endometriosis), rather than what we cannot see. We now know that adenomyosis is present in women of all ages, including adolescents, and can significantly contribute to reduced fertility and quality of life. We owe it to our patients to consider this condition in the differential diagnosis of dysmenorrhea, heavy menstrual bleeding, dyspareunia, and infertility.

CASE Resolved

The patient underwent targeted hysteroscopic resection of adenomyosis (FIGURE 5) and conceived spontaneously the following year. ●

Postpartum hemorrhage (PPH) is a common complication of birth. In 2019, 4.3% of births in the United States were complicated by at least one episode of PPH.¹ Major causes of PPH include uterine atony, retained products of conception, reproductive tract trauma, and coagulopathy.² Active management of the third stage of labor with the routine administration of postpartum uterotonics reduces the risk of PPH.^3,4

PPH treatment requires a systematic approach using appropriate uterotonic medications, tranexamic acid, and procedures performed in a timely sequence to resolve the hemorrhage. Following vaginal birth, procedures that do not require a laparotomy to treat PPH include uterine massage, uterine evacuation to remove retained placental tissue, repair of lacerations, uterine balloon tamponade (UBT), uterine packing, a vacuum-induced hemorrhage control device (VHCD; JADA, Organon), and uterine artery embolization. Following cesarean birth, with an open laparotomy incision, interventions to treat PPH due to atony include vascular ligation, uterine compression sutures, UBT, VHCD, hysterectomy, and pelvic packing.²

Over the past 2 decades, UBT has been widely used for the treatment of PPH with a success rate in observational studies of approximately 86%.⁵ The uterine balloon creates pressure against the wall of the uterus permitting accumulation of platelets at bleeding sites, enhancing the activity of the clotting system. The uterine balloon provides direct pressure on the bleeding site(s). It is well known in trauma care that the first step to treat a bleeding wound is to apply direct pressure to the bleeding site. During the third stage of labor, a natural process is tetanic uterine contraction, which constricts myometrial vessels and the placenta bed. Placing a balloon in the uterus and inflating the balloon to 200 mL to 500 mL may delay the involution of the uterus that should occur following birth. An observation of great interest is the insight that inducing a vacuum in the uterine cavity may enhance tetanic uterine contraction and constriction of the myometrial vessels. Vacuum-induced hemorrhage control is discussed in detail in this editorial.

Vacuum-induced hemorrhage control device

A new device for the treatment of PPH due to uterine atony is the JADA VHCD (FIGURE), which generates negative intrauterine pressure causing the uterus to contract, thereby constricting myometrial vessels and reducing uterine bleeding. The JADA VHCD system is indicated to provide control and treatment of abnormal postpartum uterine bleeding following vaginal or cesarean birth caused by uterine atony when conservative management is indicated.⁶

ILLUSTRATION: MARY ELLEN NIATAS FOR OBG MANAGEMENT

System components

The JADA VHCD consists of a leading portion intended to be inserted into the uterine cavity, which consists of a silicone elliptical loop with 20 vacuum pores. A soft shield covers the vacuum loop to reduce the risk of the vacuum pores being clogged with biological material, including blood and clots. The elliptical loop is attached to a catheter intended for connection to a vacuum source set to 80 mm Hg ±10 mm Hg (hospital wall suction or portable suction device) with an in-line cannister to collect blood. Approximately 16 cm from the tip of the elliptical loop is a balloon that should be positioned in the upper vagina, not inside the cervix, and inflated with fluid (60 mL to 120 mL) through a dedicated port to occlude the vagina, thereby preserving a stable intrauterine vacuum.

Continue to: Correct usage...

Correct usage

A simple mnemonic to facilitate use of the JADA VHCD is “120/80”—fill the vaginal balloon with 120 mL of sterile fluid and attach the tubing to a source that is set to provide 80 mm Hg of vacuum with an in-line collection cannister. The VHCD may not work correctly if there is a substantial amount of blood in the uterus. Clinical experts advise that an important step prior to placing the elliptical loop in the uterus is to perform a sweep of the uterine cavity with a hand or instrument to remove clots and ensure there is no retained placental tissue. It is preferable to assemble the suction tubing, syringe, sterile fluid, and other instruments (eg, forceps, speculum) needed to insert the device prior to attempting to place the VHCD. When the elliptical loop is compressed for insertion, it is about 2 cm in diameter, necessitating that the cervix be dilated sufficiently to accommodate the device.

Immediately after placing the VHCD, contractions can be monitored by physical examination and the amount of ongoing bleeding can be estimated by observing the amount of blood accumulating in the cannister. Rapid onset of a palpable increase in uterine tone is a prominent feature of successful treatment of PPH with the VHCD. The VHCD should be kept in the uterus with active suction for at least 1 hour. Taping the tubing to the inner thigh may help stabilize the device. Once bleeding is controlled, prior to removing the device, the vacuum should be discontinued, and bleeding activityshould be assessed for at least 30 minutes. If the patient is stable, the vaginal balloon can be deflated, followed by removal of the device. The VHCD should be removed within 24 hours of placement.⁶

The JADA VHCD system should not be used with ongoing intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, or serious infection of the uterus.⁶ The VHCD has not been evaluated for effectiveness in the treatment of placenta accreta or coagulopathy. The VHCD has not been specifically evaluated for safety and effectiveness in patients < 34 weeks’ duration, but clinicians report successful use of the device in cases of PPH that have occurred in the second and early-third trimesters. If the device can be appropriately placed with the elliptical loop in the uterus and the balloon in the vagina, it is theoretically possible to use the device for cases of PPH occurring before 34 weeks’ gestation.

When using the JADA VHCD system, it is important to simultaneously provide cardiovascular support, appropriate transfusion of blood products and timely surgical intervention, if indicated. All obstetricians know that in complicated cases of PPH, where conservative measures have not worked, uterine artery embolization or hysterectomy may be the only interventions that will prevent serious patient morbidity.

Effectiveness data

The VHCD has not been evaluated against an alternative approach, such as UBT, in published randomized clinical trials. However, prospective cohort studies have reported that the JADA is often successful in the treatment of PPH.^7-10

In a multicenter cohort study of 107 patients with PPH, including 91 vaginal and 16 cesarean births, 100 patients (93%) were successfully treated with the JADA VHCD.⁷ Median blood loss before application of the system was 870 mL with vaginal birth and 1,300 mL with cesarean birth. Definitive control of the hemorrhage was observed at a median of 3 minutes after initiation of the intrauterine vacuum. In this study, 32% of patients had reproductive tract lacerations that needed to be repaired, and 2 patients required a hysterectomy. Forty patients required a blood transfusion.

Two patients were treated with a Bakri UBT when the VHCD did not resolve the PPH. In this cohort, the vacuum was applied for a median duration of 144 minutes, and a median total device dwell time was 191 minutes. Compared with UBT, the JADA VHCD intrauterine dwell time was shorter, facilitating patient progression and early transfer to the postpartum unit. The physicians who participated in the study reported that the device was easy to use. The complications reported in this cohort were minor and included endometritis (5 cases), vaginal infection (2 cases), and disruption of a vaginal laceration repair (1 case).⁷

Novel approaches to generating an intrauterine vacuum to treat PPH

The JADA VHCD is the only vacuum device approved by the US Food and Drug Administration (FDA) for treatment of PPH. However, clinical innovators have reported alternative approaches to generating an intrauterine vacuum using equipment designed for other purposes. In one study, a Bakri balloon was used to generate intrauterine vacuum tamponade to treat PPH.¹¹ In this study, a Bakri balloon was inserted into the uterus, and the balloon was inflated to 50 mL to 100 mL to seal the vacuum. The main Bakri port was attached to a suction aspiration device set to generate a vacuum of 450 mm Hg to 525 mm Hg, a much greater vacuum than used with the JADA VHCD. This study included 44 cases of PPH due to uterine atony and 22 cases due to placental pathology, with successful treatment of PPH in 86% and 73% of the cases, respectively.

Another approach to generate intrauterine vacuum tamponade involves using a Levin stomach tube (FG24 or FG36), which has an open end and 4 side ports near the open tip.^12-14 The Levin stomach tube is low cost and has many favorable design features, including a rounded tip, wide-bore, and circumferentially placed side ports. The FG36 Levin stomach tube is 12 mm in diameter and has 10 mm side ports. A vacuum device set to deliver 100 mm Hg to 200 mm Hgwas used in some of the studies evaluating the Levin stomach tube for the treatment of PPH. In 3 cases of severe PPH unresponsive to standard interventions, creation of vacuum tamponade with flexible suction tubing with side ports was successful in controlling the hemorrhage.¹³

Dr. T.N. Vasudeva Panicker invented an intrauterine cannula 12 mm in diameter and 25 cm in length, with dozens of 4 mm side ports over the distal 12 cm of the cannula.¹⁵ The cannula, which is made of stainless steel or plastic, is inserted into the uterus and 700 mm Hgvacuum is applied, a level much greater than the 80 mm Hg vacuum recommended for use with the JADA VHCD. When successful, the high suction clears the uterus of blood and causes uterine contraction. In 4 cases of severe PPH, the device successfully controlled the hemorrhage. In 2 of the 4 cases the device that was initially placed became clogged with blood and needed to be replaced.

UBT vs VHCD

To date there are no published randomized controlled trials comparing Bakri UBT to the JADA VHCD. In one retrospective study, the frequency of massive transfusion of red blood cells (RBCs), defined as the transfusion of 4 units or greater of RBCs, was assessed among 78 patients treated with the Bakri UBT and 36 patients treated with the JADA VHCD.⁹ In this study, at baseline there was a non ̶ statistically significant trend for JADA VHCD to be used more frequently than the Bakri UBT in cases of PPH occurring during repeat cesarean delivery (33% vs 14%). The Bakri UBT was used more frequently than the JADA VHCD among patients having a PPH following a vaginal delivery (51% vs 31%). Both devices were used at similar rates for operative vaginal delivery (6%) and primary cesarean birth (31% VHCD and 28% UBT).

In this retrospective study, the percentage of patients treated with VHCD or UBT who received 4 or more units of RBCs was 3% and 21%, respectively (P < .01). Among patients treated with VHCD and UBT, the estimated median blood loss was 1,500 mL and 1,850 mL (P=.02), respectively. The median hemoglobin concentration at discharge was similar in the VHCD and UBT groups, 8.8 g/dL and 8.6 g/dL, respectively.⁹ A randomized controlled trial is necessary to refine our understanding of the comparative effectiveness of UBT and VHCD in controlling PPH following vaginal and cesarean birth.

A welcome addition to treatment options

Every obstetrician knows that, in the next 12 months of their practice, they will encounter multiple cases of PPH. One or two of these cases may require the physician to use every medication and procedure available for the treatment of PPH to save the life of the patient. To prepare to treat the next case of PPH rapidly and effectively, it is important for every obstetrician to develop a standardized cognitive plan for using all available treatmentmodalities in an appropriate and timely sequence, including both the Bakri balloon and the JADA VHCD. The insight that inducing an intrauterine vacuum causes uterine contraction, which may resolve PPH, is an important discovery. The JADA VHCD is a welcome addition to our armamentarium of treatments for PPH. ●
 

Postpartum hemorrhage (PPH) is a common complication of birth. In 2019, 4.3% of births in the United States were complicated by at least one episode of PPH.¹ Major causes of PPH include uterine atony, retained products of conception, reproductive tract trauma, and coagulopathy.² Active management of the third stage of labor with the routine administration of postpartum uterotonics reduces the risk of PPH.^3,4

PPH treatment requires a systematic approach using appropriate uterotonic medications, tranexamic acid, and procedures performed in a timely sequence to resolve the hemorrhage. Following vaginal birth, procedures that do not require a laparotomy to treat PPH include uterine massage, uterine evacuation to remove retained placental tissue, repair of lacerations, uterine balloon tamponade (UBT), uterine packing, a vacuum-induced hemorrhage control device (VHCD; JADA, Organon), and uterine artery embolization. Following cesarean birth, with an open laparotomy incision, interventions to treat PPH due to atony include vascular ligation, uterine compression sutures, UBT, VHCD, hysterectomy, and pelvic packing.²

Over the past 2 decades, UBT has been widely used for the treatment of PPH with a success rate in observational studies of approximately 86%.⁵ The uterine balloon creates pressure against the wall of the uterus permitting accumulation of platelets at bleeding sites, enhancing the activity of the clotting system. The uterine balloon provides direct pressure on the bleeding site(s). It is well known in trauma care that the first step to treat a bleeding wound is to apply direct pressure to the bleeding site. During the third stage of labor, a natural process is tetanic uterine contraction, which constricts myometrial vessels and the placenta bed. Placing a balloon in the uterus and inflating the balloon to 200 mL to 500 mL may delay the involution of the uterus that should occur following birth. An observation of great interest is the insight that inducing a vacuum in the uterine cavity may enhance tetanic uterine contraction and constriction of the myometrial vessels. Vacuum-induced hemorrhage control is discussed in detail in this editorial.

Vacuum-induced hemorrhage control device

A new device for the treatment of PPH due to uterine atony is the JADA VHCD (FIGURE), which generates negative intrauterine pressure causing the uterus to contract, thereby constricting myometrial vessels and reducing uterine bleeding. The JADA VHCD system is indicated to provide control and treatment of abnormal postpartum uterine bleeding following vaginal or cesarean birth caused by uterine atony when conservative management is indicated.⁶

ILLUSTRATION: MARY ELLEN NIATAS FOR OBG MANAGEMENT

System components

The JADA VHCD consists of a leading portion intended to be inserted into the uterine cavity, which consists of a silicone elliptical loop with 20 vacuum pores. A soft shield covers the vacuum loop to reduce the risk of the vacuum pores being clogged with biological material, including blood and clots. The elliptical loop is attached to a catheter intended for connection to a vacuum source set to 80 mm Hg ±10 mm Hg (hospital wall suction or portable suction device) with an in-line cannister to collect blood. Approximately 16 cm from the tip of the elliptical loop is a balloon that should be positioned in the upper vagina, not inside the cervix, and inflated with fluid (60 mL to 120 mL) through a dedicated port to occlude the vagina, thereby preserving a stable intrauterine vacuum.

Continue to: Correct usage...

Correct usage

A simple mnemonic to facilitate use of the JADA VHCD is “120/80”—fill the vaginal balloon with 120 mL of sterile fluid and attach the tubing to a source that is set to provide 80 mm Hg of vacuum with an in-line collection cannister. The VHCD may not work correctly if there is a substantial amount of blood in the uterus. Clinical experts advise that an important step prior to placing the elliptical loop in the uterus is to perform a sweep of the uterine cavity with a hand or instrument to remove clots and ensure there is no retained placental tissue. It is preferable to assemble the suction tubing, syringe, sterile fluid, and other instruments (eg, forceps, speculum) needed to insert the device prior to attempting to place the VHCD. When the elliptical loop is compressed for insertion, it is about 2 cm in diameter, necessitating that the cervix be dilated sufficiently to accommodate the device.

Immediately after placing the VHCD, contractions can be monitored by physical examination and the amount of ongoing bleeding can be estimated by observing the amount of blood accumulating in the cannister. Rapid onset of a palpable increase in uterine tone is a prominent feature of successful treatment of PPH with the VHCD. The VHCD should be kept in the uterus with active suction for at least 1 hour. Taping the tubing to the inner thigh may help stabilize the device. Once bleeding is controlled, prior to removing the device, the vacuum should be discontinued, and bleeding activityshould be assessed for at least 30 minutes. If the patient is stable, the vaginal balloon can be deflated, followed by removal of the device. The VHCD should be removed within 24 hours of placement.⁶

The JADA VHCD system should not be used with ongoing intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, or serious infection of the uterus.⁶ The VHCD has not been evaluated for effectiveness in the treatment of placenta accreta or coagulopathy. The VHCD has not been specifically evaluated for safety and effectiveness in patients < 34 weeks’ duration, but clinicians report successful use of the device in cases of PPH that have occurred in the second and early-third trimesters. If the device can be appropriately placed with the elliptical loop in the uterus and the balloon in the vagina, it is theoretically possible to use the device for cases of PPH occurring before 34 weeks’ gestation.

When using the JADA VHCD system, it is important to simultaneously provide cardiovascular support, appropriate transfusion of blood products and timely surgical intervention, if indicated. All obstetricians know that in complicated cases of PPH, where conservative measures have not worked, uterine artery embolization or hysterectomy may be the only interventions that will prevent serious patient morbidity.

Effectiveness data

The VHCD has not been evaluated against an alternative approach, such as UBT, in published randomized clinical trials. However, prospective cohort studies have reported that the JADA is often successful in the treatment of PPH.^7-10

In a multicenter cohort study of 107 patients with PPH, including 91 vaginal and 16 cesarean births, 100 patients (93%) were successfully treated with the JADA VHCD.⁷ Median blood loss before application of the system was 870 mL with vaginal birth and 1,300 mL with cesarean birth. Definitive control of the hemorrhage was observed at a median of 3 minutes after initiation of the intrauterine vacuum. In this study, 32% of patients had reproductive tract lacerations that needed to be repaired, and 2 patients required a hysterectomy. Forty patients required a blood transfusion.

Two patients were treated with a Bakri UBT when the VHCD did not resolve the PPH. In this cohort, the vacuum was applied for a median duration of 144 minutes, and a median total device dwell time was 191 minutes. Compared with UBT, the JADA VHCD intrauterine dwell time was shorter, facilitating patient progression and early transfer to the postpartum unit. The physicians who participated in the study reported that the device was easy to use. The complications reported in this cohort were minor and included endometritis (5 cases), vaginal infection (2 cases), and disruption of a vaginal laceration repair (1 case).⁷

Novel approaches to generating an intrauterine vacuum to treat PPH

The JADA VHCD is the only vacuum device approved by the US Food and Drug Administration (FDA) for treatment of PPH. However, clinical innovators have reported alternative approaches to generating an intrauterine vacuum using equipment designed for other purposes. In one study, a Bakri balloon was used to generate intrauterine vacuum tamponade to treat PPH.¹¹ In this study, a Bakri balloon was inserted into the uterus, and the balloon was inflated to 50 mL to 100 mL to seal the vacuum. The main Bakri port was attached to a suction aspiration device set to generate a vacuum of 450 mm Hg to 525 mm Hg, a much greater vacuum than used with the JADA VHCD. This study included 44 cases of PPH due to uterine atony and 22 cases due to placental pathology, with successful treatment of PPH in 86% and 73% of the cases, respectively.

Another approach to generate intrauterine vacuum tamponade involves using a Levin stomach tube (FG24 or FG36), which has an open end and 4 side ports near the open tip.^12-14 The Levin stomach tube is low cost and has many favorable design features, including a rounded tip, wide-bore, and circumferentially placed side ports. The FG36 Levin stomach tube is 12 mm in diameter and has 10 mm side ports. A vacuum device set to deliver 100 mm Hg to 200 mm Hgwas used in some of the studies evaluating the Levin stomach tube for the treatment of PPH. In 3 cases of severe PPH unresponsive to standard interventions, creation of vacuum tamponade with flexible suction tubing with side ports was successful in controlling the hemorrhage.¹³

Dr. T.N. Vasudeva Panicker invented an intrauterine cannula 12 mm in diameter and 25 cm in length, with dozens of 4 mm side ports over the distal 12 cm of the cannula.¹⁵ The cannula, which is made of stainless steel or plastic, is inserted into the uterus and 700 mm Hgvacuum is applied, a level much greater than the 80 mm Hg vacuum recommended for use with the JADA VHCD. When successful, the high suction clears the uterus of blood and causes uterine contraction. In 4 cases of severe PPH, the device successfully controlled the hemorrhage. In 2 of the 4 cases the device that was initially placed became clogged with blood and needed to be replaced.

UBT vs VHCD

To date there are no published randomized controlled trials comparing Bakri UBT to the JADA VHCD. In one retrospective study, the frequency of massive transfusion of red blood cells (RBCs), defined as the transfusion of 4 units or greater of RBCs, was assessed among 78 patients treated with the Bakri UBT and 36 patients treated with the JADA VHCD.⁹ In this study, at baseline there was a non ̶ statistically significant trend for JADA VHCD to be used more frequently than the Bakri UBT in cases of PPH occurring during repeat cesarean delivery (33% vs 14%). The Bakri UBT was used more frequently than the JADA VHCD among patients having a PPH following a vaginal delivery (51% vs 31%). Both devices were used at similar rates for operative vaginal delivery (6%) and primary cesarean birth (31% VHCD and 28% UBT).

In this retrospective study, the percentage of patients treated with VHCD or UBT who received 4 or more units of RBCs was 3% and 21%, respectively (P < .01). Among patients treated with VHCD and UBT, the estimated median blood loss was 1,500 mL and 1,850 mL (P=.02), respectively. The median hemoglobin concentration at discharge was similar in the VHCD and UBT groups, 8.8 g/dL and 8.6 g/dL, respectively.⁹ A randomized controlled trial is necessary to refine our understanding of the comparative effectiveness of UBT and VHCD in controlling PPH following vaginal and cesarean birth.

A welcome addition to treatment options

Every obstetrician knows that, in the next 12 months of their practice, they will encounter multiple cases of PPH. One or two of these cases may require the physician to use every medication and procedure available for the treatment of PPH to save the life of the patient. To prepare to treat the next case of PPH rapidly and effectively, it is important for every obstetrician to develop a standardized cognitive plan for using all available treatmentmodalities in an appropriate and timely sequence, including both the Bakri balloon and the JADA VHCD. The insight that inducing an intrauterine vacuum causes uterine contraction, which may resolve PPH, is an important discovery. The JADA VHCD is a welcome addition to our armamentarium of treatments for PPH. ●
 

Postpartum hemorrhage (PPH) is a common complication of birth. In 2019, 4.3% of births in the United States were complicated by at least one episode of PPH.¹ Major causes of PPH include uterine atony, retained products of conception, reproductive tract trauma, and coagulopathy.² Active management of the third stage of labor with the routine administration of postpartum uterotonics reduces the risk of PPH.^3,4

PPH treatment requires a systematic approach using appropriate uterotonic medications, tranexamic acid, and procedures performed in a timely sequence to resolve the hemorrhage. Following vaginal birth, procedures that do not require a laparotomy to treat PPH include uterine massage, uterine evacuation to remove retained placental tissue, repair of lacerations, uterine balloon tamponade (UBT), uterine packing, a vacuum-induced hemorrhage control device (VHCD; JADA, Organon), and uterine artery embolization. Following cesarean birth, with an open laparotomy incision, interventions to treat PPH due to atony include vascular ligation, uterine compression sutures, UBT, VHCD, hysterectomy, and pelvic packing.²

Over the past 2 decades, UBT has been widely used for the treatment of PPH with a success rate in observational studies of approximately 86%.⁵ The uterine balloon creates pressure against the wall of the uterus permitting accumulation of platelets at bleeding sites, enhancing the activity of the clotting system. The uterine balloon provides direct pressure on the bleeding site(s). It is well known in trauma care that the first step to treat a bleeding wound is to apply direct pressure to the bleeding site. During the third stage of labor, a natural process is tetanic uterine contraction, which constricts myometrial vessels and the placenta bed. Placing a balloon in the uterus and inflating the balloon to 200 mL to 500 mL may delay the involution of the uterus that should occur following birth. An observation of great interest is the insight that inducing a vacuum in the uterine cavity may enhance tetanic uterine contraction and constriction of the myometrial vessels. Vacuum-induced hemorrhage control is discussed in detail in this editorial.

Vacuum-induced hemorrhage control device

A new device for the treatment of PPH due to uterine atony is the JADA VHCD (FIGURE), which generates negative intrauterine pressure causing the uterus to contract, thereby constricting myometrial vessels and reducing uterine bleeding. The JADA VHCD system is indicated to provide control and treatment of abnormal postpartum uterine bleeding following vaginal or cesarean birth caused by uterine atony when conservative management is indicated.⁶

ILLUSTRATION: MARY ELLEN NIATAS FOR OBG MANAGEMENT

System components

The JADA VHCD consists of a leading portion intended to be inserted into the uterine cavity, which consists of a silicone elliptical loop with 20 vacuum pores. A soft shield covers the vacuum loop to reduce the risk of the vacuum pores being clogged with biological material, including blood and clots. The elliptical loop is attached to a catheter intended for connection to a vacuum source set to 80 mm Hg ±10 mm Hg (hospital wall suction or portable suction device) with an in-line cannister to collect blood. Approximately 16 cm from the tip of the elliptical loop is a balloon that should be positioned in the upper vagina, not inside the cervix, and inflated with fluid (60 mL to 120 mL) through a dedicated port to occlude the vagina, thereby preserving a stable intrauterine vacuum.

Continue to: Correct usage...

Correct usage

A simple mnemonic to facilitate use of the JADA VHCD is “120/80”—fill the vaginal balloon with 120 mL of sterile fluid and attach the tubing to a source that is set to provide 80 mm Hg of vacuum with an in-line collection cannister. The VHCD may not work correctly if there is a substantial amount of blood in the uterus. Clinical experts advise that an important step prior to placing the elliptical loop in the uterus is to perform a sweep of the uterine cavity with a hand or instrument to remove clots and ensure there is no retained placental tissue. It is preferable to assemble the suction tubing, syringe, sterile fluid, and other instruments (eg, forceps, speculum) needed to insert the device prior to attempting to place the VHCD. When the elliptical loop is compressed for insertion, it is about 2 cm in diameter, necessitating that the cervix be dilated sufficiently to accommodate the device.

Immediately after placing the VHCD, contractions can be monitored by physical examination and the amount of ongoing bleeding can be estimated by observing the amount of blood accumulating in the cannister. Rapid onset of a palpable increase in uterine tone is a prominent feature of successful treatment of PPH with the VHCD. The VHCD should be kept in the uterus with active suction for at least 1 hour. Taping the tubing to the inner thigh may help stabilize the device. Once bleeding is controlled, prior to removing the device, the vacuum should be discontinued, and bleeding activityshould be assessed for at least 30 minutes. If the patient is stable, the vaginal balloon can be deflated, followed by removal of the device. The VHCD should be removed within 24 hours of placement.⁶

The JADA VHCD system should not be used with ongoing intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, or serious infection of the uterus.⁶ The VHCD has not been evaluated for effectiveness in the treatment of placenta accreta or coagulopathy. The VHCD has not been specifically evaluated for safety and effectiveness in patients < 34 weeks’ duration, but clinicians report successful use of the device in cases of PPH that have occurred in the second and early-third trimesters. If the device can be appropriately placed with the elliptical loop in the uterus and the balloon in the vagina, it is theoretically possible to use the device for cases of PPH occurring before 34 weeks’ gestation.

When using the JADA VHCD system, it is important to simultaneously provide cardiovascular support, appropriate transfusion of blood products and timely surgical intervention, if indicated. All obstetricians know that in complicated cases of PPH, where conservative measures have not worked, uterine artery embolization or hysterectomy may be the only interventions that will prevent serious patient morbidity.

Effectiveness data

The VHCD has not been evaluated against an alternative approach, such as UBT, in published randomized clinical trials. However, prospective cohort studies have reported that the JADA is often successful in the treatment of PPH.^7-10

In a multicenter cohort study of 107 patients with PPH, including 91 vaginal and 16 cesarean births, 100 patients (93%) were successfully treated with the JADA VHCD.⁷ Median blood loss before application of the system was 870 mL with vaginal birth and 1,300 mL with cesarean birth. Definitive control of the hemorrhage was observed at a median of 3 minutes after initiation of the intrauterine vacuum. In this study, 32% of patients had reproductive tract lacerations that needed to be repaired, and 2 patients required a hysterectomy. Forty patients required a blood transfusion.

Two patients were treated with a Bakri UBT when the VHCD did not resolve the PPH. In this cohort, the vacuum was applied for a median duration of 144 minutes, and a median total device dwell time was 191 minutes. Compared with UBT, the JADA VHCD intrauterine dwell time was shorter, facilitating patient progression and early transfer to the postpartum unit. The physicians who participated in the study reported that the device was easy to use. The complications reported in this cohort were minor and included endometritis (5 cases), vaginal infection (2 cases), and disruption of a vaginal laceration repair (1 case).⁷

Novel approaches to generating an intrauterine vacuum to treat PPH

The JADA VHCD is the only vacuum device approved by the US Food and Drug Administration (FDA) for treatment of PPH. However, clinical innovators have reported alternative approaches to generating an intrauterine vacuum using equipment designed for other purposes. In one study, a Bakri balloon was used to generate intrauterine vacuum tamponade to treat PPH.¹¹ In this study, a Bakri balloon was inserted into the uterus, and the balloon was inflated to 50 mL to 100 mL to seal the vacuum. The main Bakri port was attached to a suction aspiration device set to generate a vacuum of 450 mm Hg to 525 mm Hg, a much greater vacuum than used with the JADA VHCD. This study included 44 cases of PPH due to uterine atony and 22 cases due to placental pathology, with successful treatment of PPH in 86% and 73% of the cases, respectively.

Another approach to generate intrauterine vacuum tamponade involves using a Levin stomach tube (FG24 or FG36), which has an open end and 4 side ports near the open tip.^12-14 The Levin stomach tube is low cost and has many favorable design features, including a rounded tip, wide-bore, and circumferentially placed side ports. The FG36 Levin stomach tube is 12 mm in diameter and has 10 mm side ports. A vacuum device set to deliver 100 mm Hg to 200 mm Hgwas used in some of the studies evaluating the Levin stomach tube for the treatment of PPH. In 3 cases of severe PPH unresponsive to standard interventions, creation of vacuum tamponade with flexible suction tubing with side ports was successful in controlling the hemorrhage.¹³

Dr. T.N. Vasudeva Panicker invented an intrauterine cannula 12 mm in diameter and 25 cm in length, with dozens of 4 mm side ports over the distal 12 cm of the cannula.¹⁵ The cannula, which is made of stainless steel or plastic, is inserted into the uterus and 700 mm Hgvacuum is applied, a level much greater than the 80 mm Hg vacuum recommended for use with the JADA VHCD. When successful, the high suction clears the uterus of blood and causes uterine contraction. In 4 cases of severe PPH, the device successfully controlled the hemorrhage. In 2 of the 4 cases the device that was initially placed became clogged with blood and needed to be replaced.

UBT vs VHCD

To date there are no published randomized controlled trials comparing Bakri UBT to the JADA VHCD. In one retrospective study, the frequency of massive transfusion of red blood cells (RBCs), defined as the transfusion of 4 units or greater of RBCs, was assessed among 78 patients treated with the Bakri UBT and 36 patients treated with the JADA VHCD.⁹ In this study, at baseline there was a non ̶ statistically significant trend for JADA VHCD to be used more frequently than the Bakri UBT in cases of PPH occurring during repeat cesarean delivery (33% vs 14%). The Bakri UBT was used more frequently than the JADA VHCD among patients having a PPH following a vaginal delivery (51% vs 31%). Both devices were used at similar rates for operative vaginal delivery (6%) and primary cesarean birth (31% VHCD and 28% UBT).

In this retrospective study, the percentage of patients treated with VHCD or UBT who received 4 or more units of RBCs was 3% and 21%, respectively (P < .01). Among patients treated with VHCD and UBT, the estimated median blood loss was 1,500 mL and 1,850 mL (P=.02), respectively. The median hemoglobin concentration at discharge was similar in the VHCD and UBT groups, 8.8 g/dL and 8.6 g/dL, respectively.⁹ A randomized controlled trial is necessary to refine our understanding of the comparative effectiveness of UBT and VHCD in controlling PPH following vaginal and cesarean birth.

A welcome addition to treatment options

Every obstetrician knows that, in the next 12 months of their practice, they will encounter multiple cases of PPH. One or two of these cases may require the physician to use every medication and procedure available for the treatment of PPH to save the life of the patient. To prepare to treat the next case of PPH rapidly and effectively, it is important for every obstetrician to develop a standardized cognitive plan for using all available treatmentmodalities in an appropriate and timely sequence, including both the Bakri balloon and the JADA VHCD. The insight that inducing an intrauterine vacuum causes uterine contraction, which may resolve PPH, is an important discovery. The JADA VHCD is a welcome addition to our armamentarium of treatments for PPH. ●
 

Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.

That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?

Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.

Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.

Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.

It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
 

Where zuranolone fits into the treatment algorithm for severe PPD

Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:

Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.

Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.

Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?

Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.

The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.

Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.

That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?

Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.

Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.

Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.

It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
 

Where zuranolone fits into the treatment algorithm for severe PPD

Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:

Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.

Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.

Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?

Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.

The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.

Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.

That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?

Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.

Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.

Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.

It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
 

Where zuranolone fits into the treatment algorithm for severe PPD

Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:

Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.

Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.

Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?

Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.

The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.

Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].