Women's Health

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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.

Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.

Elina Maymind

I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.

No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.

But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.

Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.

Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.

Despite the very real and difficult challenges in finding a perfect balance and having it all, both at home and at work, the role of mother and physician must be intimately intertwined. Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.

Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.

Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.

Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.

Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.

Elina Maymind

I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.

No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.

But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.

Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.

Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.

Despite the very real and difficult challenges in finding a perfect balance and having it all, both at home and at work, the role of mother and physician must be intimately intertwined. Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.

Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.

Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.

Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.

Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.

Elina Maymind

I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.

No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.

But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.

Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.

Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.

Despite the very real and difficult challenges in finding a perfect balance and having it all, both at home and at work, the role of mother and physician must be intimately intertwined. Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.

Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.

Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.

Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.

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.

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.

Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.

Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.

In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.

The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.

One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).

No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.

The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.

The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.

The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m² may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.

However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.

“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
 

Pill combination shows potential and practicality

Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.

Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”

Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.

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

Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.

Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.

In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.

The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.

One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).

No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.

The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.

The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.

The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m² may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.

However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.

“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
 

Pill combination shows potential and practicality

Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.

Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”

Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.

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

Adding oral piroxicam to oral levonorgestrel significantly improved the efficacy of emergency contraception, based on data from 860 women.

Oral hormonal emergency contraception (EC) is the most widely used EC method worldwide, but the two currently available drugs, levonorgestrel and ulipristal acetate (UPA), are not effective when given after ovulation, wrote Raymond Hang Wun Li, MD, of the University of Hong Kong, and colleagues. Previous studies suggest that cyclo-oxygenase (COX) inhibitors may disrupt follicular rupture and prevent ovulation, but data on their use in combination with current oral ECs are lacking, the researchers said.

In a study published in The Lancet, the researchers randomized 430 women to receive a single oral dose of 1.5 mg levonorgestrel plus 40 mg of the COX-2 inhibitor piroxicam or 1.5 mg levonorgestrel plus a placebo. The study participants were women aged 18 years and older who requested EC within 72 hours of unprotected sex and who had regular menstrual cycles between 24 and 42 days long. The median age of the participants was 30 years; 97% were Chinese. The median time from intercourse to treatment was 18 hours for both groups.

The primary outcome was the percentage of pregnancies prevented, based on pregnancy status 1-2 weeks after treatment.

One pregnancy occurred in the piroxicam group, compared with seven pregnancies in the placebo group, which translated to a significant difference in the percentage of pregnancies prevented (94.7% vs. 63.4%, P < .0001).

No trend toward increased failure rates appeared based on the time elapsed between intercourse and EC use in either group, and no differences appeared in the return or delay of subsequent menstrual periods between the groups.

The most common adverse events (reported by more than 5% of participants in both groups) included fatigue or weakness, nausea, lower abdominal pain, dizziness, and headache.

The choice of piroxicam as the COX inhibitor in conjunction with levonorgestrel for the current study had several potential advantages, the researchers wrote in their discussion. These advantages include the widespread availability and long-acting characteristics of piroxicam, which is also true of levonorgestrel, they said.

The findings were limited by several factors including the generalizability to other settings and populations, the researchers noted. The efficacy of the levonorgestrel/piroxicam combination in women with a body mass index greater than 26 kg/m² may be lower, but the current study population did not have enough women in this category to measure the potential effect, they said. The study also did not examine the effect of piroxicam in combination with ulipristal acetate.

However, the results are the first known to demonstrate the improved effectiveness of oral piroxicam coadministered with oral levonorgestrel for EC, they said.

“The strength of this recommendation and changes in clinical guidelines may be determined upon demonstration of reproducible results in further studies,” they added.
 

Pill combination shows potential and practicality

Oral emergency contraception on demand is an unmet need on a global level, Erica P. Cahill, MD, of the department of obstetrics and gynecology and division of family planning services at Stanford (Calif.) University, wrote in an accompanying editorial.

Dr. Cahill noted the longer half-life of piroxicam compared with other COX-2 inhibitors, which made it a practical choice. Although the study was not powered to evaluate secondary outcomes, bleeding patterns consistent with use of EC pills were observed. Documentation of these patterns is worthwhile, Dr. Cahill said, “because people using emergency contraceptive pills might also be using fertility awareness methods and need to know when they can be certain they are not pregnant.”

Overall, the study supports the addition of 40 mg piroxicam to 1.5 mg levonorgestrel as emergency contraception, said Dr. Cahill. Future studies can build on the current findings by evaluating repeat dosing of the piroxicam/levonorgestrel combination and by evaluating the combination of COX-2 inhibitors and ulipristal acetate to prevent pregnancy, she said.

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

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.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.

For patients with uterine prolapse, a traditional technique showed superiority, while vaginal estrogen cream failed to improve outcomes for vaginal apical prolapse repair in two new studies published in JAMA.

“Approximately one in five women will undergo surgery for prolapse and/or urinary incontinence by the age of 80, which is more likely than the risk of developing breast cancer,” said David D. Rahn, MD, corresponding author of the study on perioperative vaginal estrogen, in an interview.

University of Texas Southwestern Medical Center

“About 13% of women will specifically undergo surgery to repair pelvic organ prolapse,” said Dr. Rahn, of the department of obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas. Reoperation for recurrent prolapse is not uncommon.

In their study, Dr. Rahn and colleagues examined whether the addition of perioperative vaginal estrogen cream in postmenopausal women with prolapse planning surgical correction could both strengthen the repair and lessen the likelihood of recurrence. The researchers randomized 206 postmenopausal women who were seeking surgical repair for bothersome anterior and apical vaginal prolapse to 1 gram of conjugated estrogen cream or a placebo for nightly vaginal insertion for 2 weeks, then twice weekly for at least 5 weeks of preoperative use. The treatment continued twice weekly for 12 months following surgery.

The primary outcome was the time to a failed prolapse repair by 12 months after surgery. Failure was defined by at least one of three criteria, “anatomical/objective prolapse of anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment,” the researchers wrote. The mean age of the patients was 65 years, and 90% and 92% of patients in the treatment and placebo groups, respectively, were White; 10% and 5%, respectively, were Black. Other baseline characteristics were similar between the groups.

After 12 months, the surgical failure incidence was not significantly different between the vaginal estrogen and placebo groups (19% vs. 9%, respectively; adjusted hazard ratio, 1.97).

Overall, anatomic recurrence was the most common outcome associated with surgical failure.

However, vaginal atrophy scores for most bothersome symptom was significantly better at 12 months in the vaginal estrogen group, compared with the placebo group, in a subset of 109 patients who reported vaginal atrophy that was at least “moderately bothersome,” the researchers said.

The findings were limited by several factors including the use of a nonvalidated instrument to assess secondary outcomes, the potentially short time period to the primary outcome, and the inclusion of the apex descending below one third total vaginal length as a criterion for surgical failure (which could be considered conservative), the researchers noted.
 

Unexpected results

“This work followed logically from a pilot study that similarly randomized postmenopausal women with prolapse planning surgical repair to vaginal estrogen cream versus placebo,” Dr. Rahn said. “In that smaller study, full thickness vaginal wall biopsies were collected at the time of surgery. Those participants who received the estrogen had a thicker vaginal epithelium, thicker underlying muscularis, and appeared to have a more robust concentration of strong connective tissue (i.e., type I collagen) with less of the proteases that break down connective tissue.”

This suggested that preoperative estrogen might optimize the vaginal tissue at the time of the repair. Dr. Rahn said. However, “despite evidence that the application of vaginal estrogen cream decreased the symptoms and signs of atrophic vaginal tissues, this did not lessen the likelihood of pelvic organ prolapse recurrence 12 months after surgical repair.”

The current study “would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts and commonly prescribed anecdotally,” said Dr. Rahn. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, vaginal estrogen may still be appropriate,” and vaginal estrogen also could be useful for postoperatively for patients prone to recurrent urinary tract infections. 

Additional research from the study is underway, said Dr. Rahn. “All participants have now been followed to 3 years after surgery, and those clinical results are now being analyzed. In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries; these are being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased (or decreased) risk for prolapse recurrence.”
 

Manchester technique surpasses sacrospinous hysteropexy

In the second JAMA study, sacrospinous hysteropexy for uterine-sparing surgical management of uterine prolapse was less effective than the older Manchester procedure, based on data from nearly 400 individuals.

“Until now, the optimal uterus-sparing procedure for the treatment of uterine descent remained uncertain,” lead author Rosa Enklaar, MD, of Radboud (the Netherlands) University Medical Center, said in an interview.

courtesy Radboud University Medical Center

“Globally, there has been a lack of scientific evidence comparing the efficacy of these two techniques, and this study aims to bridge that gap,” she said.

In their study, Dr. Enklaar and colleagues randomized 215 women to sacrospinous hysteropexy and 215 to the Manchester procedure. The mean age of the participants was 61.7 years.

The Manchester procedure involves “extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus and amputation of the cervix,” and “the cardinal ligaments are plicated on the anterior side of the cervix, “ the researchers wrote.

The primary outcome was a composite outcome of surgical success at 2 years after surgery, defined as the absence of three elements: absence of vaginal prolapse beyond the hymen, absence of bothersome bulge symptoms, and absence of retreatment of current prolapse.

Overall, 87.3% of patients in the Manchester group and 77.0% in the sacrospinous hysteropexy group met the primary outcome. At the end of the 2-year follow-up period, perioperative and patient-reported outcomes were not significantly different between the groups.

Dr. Enklaar said she was surprised by the findings. “At the start of this study, we hypothesized that there would be no difference between the two techniques,” as both have been used for a long period of time.

However, “based on the composite outcome of success at 2-year follow-up after the primary uterus-sparing surgery for uterine descent in patients with pelvic organ prolapse, these findings indicate that the sacrospinous hysteropexy is inferior to the Manchester procedure,” she said.

The study findings were limited by several factors including the lack of blinding and the applicability of the results only to women without uterine prolapse past the hymen, as well as the exclusion of patients with higher-stage prolapse, the researchers said. However, the results suggest that sacrospinous hysteropexy is inferior to the Manchester technique for uterine-sparing pelvic organ prolapse surgery.

As for additional research, few studies of prolapse surgery with long-term follow-up data are available, Dr. Enklaar said. “It is important that this current study will be continued to see the results after a longer follow-up period. Personalized health care is increasingly important, and we need to provide adequate information when counselling patients. With studies such as this one, we hope to improve the choices regarding surgical treatment of uterine descent.”
 

Studies challenge current prolapse protocols

The study by Dr. Rahn and colleagues contradicts the common clinical practice of preoperative vaginal estrogen to reduce recurrence of prolapse, wrote Charles W. Nager, MD, of the University of California San Diego Health, La Jolla, in an accompanying editorial that addressed both studies.

University of California San Diego Health

The results suggest that use of perioperative intravaginal estrogen had no impact on outcomes, “despite the surgeon assessment of less atrophy and better vaginal apex tissue in the estrogen group,” he noted. Although vaginal estrogen has other benefits in terms of patient symptoms and effects on the vaginal epithelium, “surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success.”

The study by Dr. Enklaar and colleagues reflects the growing interest in uterine-conserving procedures, Dr. Nager wrote. The modified Manchester procedure conforms to professional society guidelines, and the composite outcome conforms to current standards for the treatment of pelvic organ prolapse.

Although suspension of the vaginal apex was quite successful, the researchers interpreted their noninferiority findings with caution, said Dr. Nager. However, they suggested that the modified Manchester procedure as performed in their study “has a role in modern prolapse surgical repair for women with uterine descent that does not protrude beyond the hymen.”

The vaginal estrogen study was supported by the National Institute on Aging, a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Dr. Rahn disclosed grants from the National Institute on Aging, the American Board of Obstetrics & Gynecology, and the AAOGF bridge award, as well as nonfinancial support from National Center for Advancing Translational Sciences and Pfizer during the study. The uterine prolapse study was supported by the Netherlands Organisation for Health Research and Development. The researchers had no financial conflicts to disclose. Dr. Nager had no financial conflicts to disclose.