Women's Health

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

[email protected]

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

[email protected]

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

[email protected]

The risk of neural tube defects linked to dolutegravir exposure during pregnancy is lower than previously signaled, according to new reports that have prompted the World Health Organization (WHO) to confirm that this antiviral medication should be the preferred option across all populations.

alexskopje/Thinkstock

The use of dolutegravir (DTG) during pregnancy has been a pressing global health question since May 2018, when an unplanned interim analysis of the Tsepamo surveillance study of birth outcomes in Botswana showed four neural tube defects associated with dolutegravir exposure among 426 infants born to HIV-positive women (0.94%).

With follow-up for additional births, however, just one more neural tube defect was identified out of 1,683 deliveries among women who had taken DTG around the time of conception (0.30%), according to a report just presented here at the at the International AIDS Society Conference on HIV Science.

By comparison, prevalence rates of neural tube defects were 0.10% for mothers taking other antiretroviral therapies at conception, 0.04% for those specifically taking efavirenz at conception, and 0.08% in HIV-uninfected mothers, according to the report, which was simultaneously published in the New England Journal of Medicine.

“While there may be a risk for neural tube defects, this risk is small, and really importantly, needs to be weighed against the large potential benefits of dolutegravir,” investigator Rebecca M. Zash, MD, of Beth Israel Deaconess Medical Center, Boston, said here in Mexico City during an IAS 2019 video press conference.

The WHO had previously sounded a note of caution, saying that DTG could be “considered” in women of childbearing age if other first‐line antiretroviral agents such as efavirenz could not be used.

However, following release of new evidence, including the study by Dr. Zash and colleagues, the WHO has come out with a clear recommendation for HIV drug as “the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.”

The updated scientific reports and guidelines have important implications for global health. “Many countries have been working to make dolutegravir-based treatment their preferred first-line regimen, as it’s got several advantages over efavirenz, which people have been using for many years now, including its tolerability and resistance profiles, and its impact on morbidity and mortality,” IAS president Anton Pozniak, MD, said in the press conference.

Some countries paused their plans to roll out dolutegravir-based regimens after the preliminary safety signal from the Tsepamo study was reported, Dr. Pozniak added.

In another study presented at IAS looking at dolutegravir use at conception, investigators described an additional surveillance study in Botswana, conducted independently from the Tsepamo study. One neural tube defect was found among 152 deliveries in mothers who had been taking DTG at conception (0.66%), and two neural tube defects among 2,326 deliveries to HIV-negative mothers (0.09%).

Although the number of deliveries are small in this study, the results suggest a risk of neural tube defects with DTG exposure at conception of less than 1%, said Mmakgomo Mimi Raesima, MD, MPH, public health specialist, Ministry of Health and Wellness, Botswana.

Because neural-tube defects might be related to low folate levels, Dr. Raesima said “conversations are continuing” with regard to folate food fortification in Botswana, a country that does not mandate folate-fortified grains.

“We want to capitalize on the momentum from these results,” Dr. Raesima said in the press conference.

The Tsepamo study was funded by the National Institutes of Health. Dr. Zash reported grants during the conduct of the study from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Zash R et al. N Engl J Med. 2019 Jul 22. doi: 10.1056/NEJMoa1905230.

The risk of neural tube defects linked to dolutegravir exposure during pregnancy is lower than previously signaled, according to new reports that have prompted the World Health Organization (WHO) to confirm that this antiviral medication should be the preferred option across all populations.

alexskopje/Thinkstock

The use of dolutegravir (DTG) during pregnancy has been a pressing global health question since May 2018, when an unplanned interim analysis of the Tsepamo surveillance study of birth outcomes in Botswana showed four neural tube defects associated with dolutegravir exposure among 426 infants born to HIV-positive women (0.94%).

With follow-up for additional births, however, just one more neural tube defect was identified out of 1,683 deliveries among women who had taken DTG around the time of conception (0.30%), according to a report just presented here at the at the International AIDS Society Conference on HIV Science.

By comparison, prevalence rates of neural tube defects were 0.10% for mothers taking other antiretroviral therapies at conception, 0.04% for those specifically taking efavirenz at conception, and 0.08% in HIV-uninfected mothers, according to the report, which was simultaneously published in the New England Journal of Medicine.

“While there may be a risk for neural tube defects, this risk is small, and really importantly, needs to be weighed against the large potential benefits of dolutegravir,” investigator Rebecca M. Zash, MD, of Beth Israel Deaconess Medical Center, Boston, said here in Mexico City during an IAS 2019 video press conference.

The WHO had previously sounded a note of caution, saying that DTG could be “considered” in women of childbearing age if other first‐line antiretroviral agents such as efavirenz could not be used.

However, following release of new evidence, including the study by Dr. Zash and colleagues, the WHO has come out with a clear recommendation for HIV drug as “the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.”

The updated scientific reports and guidelines have important implications for global health. “Many countries have been working to make dolutegravir-based treatment their preferred first-line regimen, as it’s got several advantages over efavirenz, which people have been using for many years now, including its tolerability and resistance profiles, and its impact on morbidity and mortality,” IAS president Anton Pozniak, MD, said in the press conference.

Some countries paused their plans to roll out dolutegravir-based regimens after the preliminary safety signal from the Tsepamo study was reported, Dr. Pozniak added.

In another study presented at IAS looking at dolutegravir use at conception, investigators described an additional surveillance study in Botswana, conducted independently from the Tsepamo study. One neural tube defect was found among 152 deliveries in mothers who had been taking DTG at conception (0.66%), and two neural tube defects among 2,326 deliveries to HIV-negative mothers (0.09%).

Although the number of deliveries are small in this study, the results suggest a risk of neural tube defects with DTG exposure at conception of less than 1%, said Mmakgomo Mimi Raesima, MD, MPH, public health specialist, Ministry of Health and Wellness, Botswana.

Because neural-tube defects might be related to low folate levels, Dr. Raesima said “conversations are continuing” with regard to folate food fortification in Botswana, a country that does not mandate folate-fortified grains.

“We want to capitalize on the momentum from these results,” Dr. Raesima said in the press conference.

The Tsepamo study was funded by the National Institutes of Health. Dr. Zash reported grants during the conduct of the study from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Zash R et al. N Engl J Med. 2019 Jul 22. doi: 10.1056/NEJMoa1905230.

The risk of neural tube defects linked to dolutegravir exposure during pregnancy is lower than previously signaled, according to new reports that have prompted the World Health Organization (WHO) to confirm that this antiviral medication should be the preferred option across all populations.

alexskopje/Thinkstock

The use of dolutegravir (DTG) during pregnancy has been a pressing global health question since May 2018, when an unplanned interim analysis of the Tsepamo surveillance study of birth outcomes in Botswana showed four neural tube defects associated with dolutegravir exposure among 426 infants born to HIV-positive women (0.94%).

With follow-up for additional births, however, just one more neural tube defect was identified out of 1,683 deliveries among women who had taken DTG around the time of conception (0.30%), according to a report just presented here at the at the International AIDS Society Conference on HIV Science.

By comparison, prevalence rates of neural tube defects were 0.10% for mothers taking other antiretroviral therapies at conception, 0.04% for those specifically taking efavirenz at conception, and 0.08% in HIV-uninfected mothers, according to the report, which was simultaneously published in the New England Journal of Medicine.

“While there may be a risk for neural tube defects, this risk is small, and really importantly, needs to be weighed against the large potential benefits of dolutegravir,” investigator Rebecca M. Zash, MD, of Beth Israel Deaconess Medical Center, Boston, said here in Mexico City during an IAS 2019 video press conference.

The WHO had previously sounded a note of caution, saying that DTG could be “considered” in women of childbearing age if other first‐line antiretroviral agents such as efavirenz could not be used.

However, following release of new evidence, including the study by Dr. Zash and colleagues, the WHO has come out with a clear recommendation for HIV drug as “the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.”

The updated scientific reports and guidelines have important implications for global health. “Many countries have been working to make dolutegravir-based treatment their preferred first-line regimen, as it’s got several advantages over efavirenz, which people have been using for many years now, including its tolerability and resistance profiles, and its impact on morbidity and mortality,” IAS president Anton Pozniak, MD, said in the press conference.

Some countries paused their plans to roll out dolutegravir-based regimens after the preliminary safety signal from the Tsepamo study was reported, Dr. Pozniak added.

In another study presented at IAS looking at dolutegravir use at conception, investigators described an additional surveillance study in Botswana, conducted independently from the Tsepamo study. One neural tube defect was found among 152 deliveries in mothers who had been taking DTG at conception (0.66%), and two neural tube defects among 2,326 deliveries to HIV-negative mothers (0.09%).

Although the number of deliveries are small in this study, the results suggest a risk of neural tube defects with DTG exposure at conception of less than 1%, said Mmakgomo Mimi Raesima, MD, MPH, public health specialist, Ministry of Health and Wellness, Botswana.

Because neural-tube defects might be related to low folate levels, Dr. Raesima said “conversations are continuing” with regard to folate food fortification in Botswana, a country that does not mandate folate-fortified grains.

“We want to capitalize on the momentum from these results,” Dr. Raesima said in the press conference.

The Tsepamo study was funded by the National Institutes of Health. Dr. Zash reported grants during the conduct of the study from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Zash R et al. N Engl J Med. 2019 Jul 22. doi: 10.1056/NEJMoa1905230.

LOS ANGELES – Estrogen therapy may have scored another goal in its comeback game, as a 7-year prospective study shows that a transdermal formulation preserves some measures of cognitive function and brain architecture in postmenopausal women.

JackF/thinkstockphotos.com

In addition to performing better on subjective tests of memory, women using the estrogen patch experienced less cortical atrophy and were less likely to show amyloid on brain imaging. The observations were moderately associated with the improved sleep these women reported, Burcu Zeydan, MD, said at the Alzheimer’s Association International Conference.

“By 7 years, among the cognitive domains studied ... [less brain and cognitive change] correlated with lower global sleep score, meaning better sleep quality in the estradiol group,” said Dr. Zeydan, assistant professor of radiology at the Mayo Clinic in Rochester, Minn. “We previously found that preservation of dorsolateral prefrontal cortex over 7 years was associated with lower cortical beta-amyloid deposition on PET only in the estradiol group, pointing out the potential role of estrogen receptors in modulating this relationship.”

Dysregulated sleep is more common among women than men, particularly as menopause approaches and estrogen levels fluctuate, then decline, Dr. Zeydan said.

Dr. Zeydan reported the sleep substudy of KEEPS (the Kronos Early Estrogen Prevention Study), a randomized, double-blind, placebo-controlled, multisite trial that compared oral conjugated equine estrogen with transdermal estradiol. A control group received oral placebo and a placebo patch.*

Brain architecture was similar between the placebo and transdermal groups, but it was actually worse in some measures in the oral-estrogen group, compared with the placebo group. Women taking oral estrogen had more white matter hyperintensities, greater ventricle enlargement, and more cortical thinning. Those differences resolved after they stopped taking the oral formulation, bringing them into line with the transdermal and placebo groups.

The investigation also found that the transdermal group showed lower cerebral amyloid binding on PET scans relative to both placebo and oral estrogen.

“The relative preservation of dorsolateral prefrontal cortical volume in the [transdermal estradiol] group over 7 years indicates that hormone therapy may have long-term effects on the brain,” the team concluded. They noted that the original KEEPS study didn’t find any cognitive correlation with these changes.

The subanalysis looked at 69 women of the KEEPS cohort who had been followed for the full 7 years (4 years on treatment and 3 years off treatment). They were randomized to oral placebo and a placebo patch,* oral conjugated equine estrogen (0.45 mg/day), or transdermal estradiol (50 mcg/day). Participants in the active treatment groups received oral micronized progesterone 12 days each month. All had complete data on cognitive testing and brain imaging. Sleep quality was measured by the Pittsburgh Sleep Quality Index. Dr. Zeydan compared cognition and brain architecture findings in relation to the sleep score; lower scores mean better sleep.

The women were aged 42-58 years at baseline, and within 36 months from menopause. They had no history of menopausal hormone therapy or cardiovascular disease.

The investigators were particularly interested in how estrogen might have modulated the disturbed sleep patterns that often accompany perimenopause and early menopause, and whether the observed brain and cognitive changes tracked with sleep quality.

“During this time, 40% to 60% of women report problems sleeping, and estrogen decline seems to play an important role in sleep disturbances during this phase,” Dr. Zeydan said. “Although poor sleep quality is common in recently menopausal women, sleep quality improves with hormone therapy, as was previously demonstrated in KEEPS hormone therapy trial in recently menopausal women.”

By year 7, the cohort’s mean age was 61 years. The majority had at least some college education. The percentage who carried an apolipoprotein E epsilon-4 allele varied by group, with 15% positivity in the oral group, 48% in the transdermal group, and 16% in the placebo group.


Cognitive function was estimated with a global cognitive measure and four cognitive domain scores: verbal learning and memory, auditory attention and working memory, visual attention and executive function, and mental flexibility.

Higher attention and executive function scores were moderately correlated with a lower sleep score in the transdermal group (r = –0.54, a significant difference compared with the oral formulation). Lower sleep scores also showed a moderate correlation with preserved cortical volume of the dorsolateral prefrontal region (r = –0.47, also significantly different from the oral group).

Lower brain amyloid also positively correlated with better sleep. The correlation between sleep and global amyloid burden in the transdermal group was also moderate (r = 0.45), while the correlation in the oral group was significantly weaker (r = 0.18).

“We can say that sleep quality and transdermal estradiol during early postmenopausal years somehow interact to influence beta-amyloid deposition, preservation of dorsolateral prefrontal cortex volume, and attention and executive function,” Dr. Zeydan said.

Dr. Zeydan had no financial disclosures.

[email protected]

*Correction, 8/7/2019: An earlier version of this story did not make clear that participants in the control group received oral placebo and a placebo patch.

LOS ANGELES – Estrogen therapy may have scored another goal in its comeback game, as a 7-year prospective study shows that a transdermal formulation preserves some measures of cognitive function and brain architecture in postmenopausal women.

JackF/thinkstockphotos.com

In addition to performing better on subjective tests of memory, women using the estrogen patch experienced less cortical atrophy and were less likely to show amyloid on brain imaging. The observations were moderately associated with the improved sleep these women reported, Burcu Zeydan, MD, said at the Alzheimer’s Association International Conference.

“By 7 years, among the cognitive domains studied ... [less brain and cognitive change] correlated with lower global sleep score, meaning better sleep quality in the estradiol group,” said Dr. Zeydan, assistant professor of radiology at the Mayo Clinic in Rochester, Minn. “We previously found that preservation of dorsolateral prefrontal cortex over 7 years was associated with lower cortical beta-amyloid deposition on PET only in the estradiol group, pointing out the potential role of estrogen receptors in modulating this relationship.”

Dysregulated sleep is more common among women than men, particularly as menopause approaches and estrogen levels fluctuate, then decline, Dr. Zeydan said.

Dr. Zeydan reported the sleep substudy of KEEPS (the Kronos Early Estrogen Prevention Study), a randomized, double-blind, placebo-controlled, multisite trial that compared oral conjugated equine estrogen with transdermal estradiol. A control group received oral placebo and a placebo patch.*

Brain architecture was similar between the placebo and transdermal groups, but it was actually worse in some measures in the oral-estrogen group, compared with the placebo group. Women taking oral estrogen had more white matter hyperintensities, greater ventricle enlargement, and more cortical thinning. Those differences resolved after they stopped taking the oral formulation, bringing them into line with the transdermal and placebo groups.

The investigation also found that the transdermal group showed lower cerebral amyloid binding on PET scans relative to both placebo and oral estrogen.

“The relative preservation of dorsolateral prefrontal cortical volume in the [transdermal estradiol] group over 7 years indicates that hormone therapy may have long-term effects on the brain,” the team concluded. They noted that the original KEEPS study didn’t find any cognitive correlation with these changes.

The subanalysis looked at 69 women of the KEEPS cohort who had been followed for the full 7 years (4 years on treatment and 3 years off treatment). They were randomized to oral placebo and a placebo patch,* oral conjugated equine estrogen (0.45 mg/day), or transdermal estradiol (50 mcg/day). Participants in the active treatment groups received oral micronized progesterone 12 days each month. All had complete data on cognitive testing and brain imaging. Sleep quality was measured by the Pittsburgh Sleep Quality Index. Dr. Zeydan compared cognition and brain architecture findings in relation to the sleep score; lower scores mean better sleep.

The women were aged 42-58 years at baseline, and within 36 months from menopause. They had no history of menopausal hormone therapy or cardiovascular disease.

The investigators were particularly interested in how estrogen might have modulated the disturbed sleep patterns that often accompany perimenopause and early menopause, and whether the observed brain and cognitive changes tracked with sleep quality.

“During this time, 40% to 60% of women report problems sleeping, and estrogen decline seems to play an important role in sleep disturbances during this phase,” Dr. Zeydan said. “Although poor sleep quality is common in recently menopausal women, sleep quality improves with hormone therapy, as was previously demonstrated in KEEPS hormone therapy trial in recently menopausal women.”

By year 7, the cohort’s mean age was 61 years. The majority had at least some college education. The percentage who carried an apolipoprotein E epsilon-4 allele varied by group, with 15% positivity in the oral group, 48% in the transdermal group, and 16% in the placebo group.


Cognitive function was estimated with a global cognitive measure and four cognitive domain scores: verbal learning and memory, auditory attention and working memory, visual attention and executive function, and mental flexibility.

Higher attention and executive function scores were moderately correlated with a lower sleep score in the transdermal group (r = –0.54, a significant difference compared with the oral formulation). Lower sleep scores also showed a moderate correlation with preserved cortical volume of the dorsolateral prefrontal region (r = –0.47, also significantly different from the oral group).

Lower brain amyloid also positively correlated with better sleep. The correlation between sleep and global amyloid burden in the transdermal group was also moderate (r = 0.45), while the correlation in the oral group was significantly weaker (r = 0.18).

“We can say that sleep quality and transdermal estradiol during early postmenopausal years somehow interact to influence beta-amyloid deposition, preservation of dorsolateral prefrontal cortex volume, and attention and executive function,” Dr. Zeydan said.

Dr. Zeydan had no financial disclosures.

[email protected]

*Correction, 8/7/2019: An earlier version of this story did not make clear that participants in the control group received oral placebo and a placebo patch.

LOS ANGELES – Estrogen therapy may have scored another goal in its comeback game, as a 7-year prospective study shows that a transdermal formulation preserves some measures of cognitive function and brain architecture in postmenopausal women.

JackF/thinkstockphotos.com

In addition to performing better on subjective tests of memory, women using the estrogen patch experienced less cortical atrophy and were less likely to show amyloid on brain imaging. The observations were moderately associated with the improved sleep these women reported, Burcu Zeydan, MD, said at the Alzheimer’s Association International Conference.

“By 7 years, among the cognitive domains studied ... [less brain and cognitive change] correlated with lower global sleep score, meaning better sleep quality in the estradiol group,” said Dr. Zeydan, assistant professor of radiology at the Mayo Clinic in Rochester, Minn. “We previously found that preservation of dorsolateral prefrontal cortex over 7 years was associated with lower cortical beta-amyloid deposition on PET only in the estradiol group, pointing out the potential role of estrogen receptors in modulating this relationship.”

Dysregulated sleep is more common among women than men, particularly as menopause approaches and estrogen levels fluctuate, then decline, Dr. Zeydan said.

Dr. Zeydan reported the sleep substudy of KEEPS (the Kronos Early Estrogen Prevention Study), a randomized, double-blind, placebo-controlled, multisite trial that compared oral conjugated equine estrogen with transdermal estradiol. A control group received oral placebo and a placebo patch.*

Brain architecture was similar between the placebo and transdermal groups, but it was actually worse in some measures in the oral-estrogen group, compared with the placebo group. Women taking oral estrogen had more white matter hyperintensities, greater ventricle enlargement, and more cortical thinning. Those differences resolved after they stopped taking the oral formulation, bringing them into line with the transdermal and placebo groups.

The investigation also found that the transdermal group showed lower cerebral amyloid binding on PET scans relative to both placebo and oral estrogen.

“The relative preservation of dorsolateral prefrontal cortical volume in the [transdermal estradiol] group over 7 years indicates that hormone therapy may have long-term effects on the brain,” the team concluded. They noted that the original KEEPS study didn’t find any cognitive correlation with these changes.

The subanalysis looked at 69 women of the KEEPS cohort who had been followed for the full 7 years (4 years on treatment and 3 years off treatment). They were randomized to oral placebo and a placebo patch,* oral conjugated equine estrogen (0.45 mg/day), or transdermal estradiol (50 mcg/day). Participants in the active treatment groups received oral micronized progesterone 12 days each month. All had complete data on cognitive testing and brain imaging. Sleep quality was measured by the Pittsburgh Sleep Quality Index. Dr. Zeydan compared cognition and brain architecture findings in relation to the sleep score; lower scores mean better sleep.

The women were aged 42-58 years at baseline, and within 36 months from menopause. They had no history of menopausal hormone therapy or cardiovascular disease.

The investigators were particularly interested in how estrogen might have modulated the disturbed sleep patterns that often accompany perimenopause and early menopause, and whether the observed brain and cognitive changes tracked with sleep quality.

“During this time, 40% to 60% of women report problems sleeping, and estrogen decline seems to play an important role in sleep disturbances during this phase,” Dr. Zeydan said. “Although poor sleep quality is common in recently menopausal women, sleep quality improves with hormone therapy, as was previously demonstrated in KEEPS hormone therapy trial in recently menopausal women.”

By year 7, the cohort’s mean age was 61 years. The majority had at least some college education. The percentage who carried an apolipoprotein E epsilon-4 allele varied by group, with 15% positivity in the oral group, 48% in the transdermal group, and 16% in the placebo group.


Cognitive function was estimated with a global cognitive measure and four cognitive domain scores: verbal learning and memory, auditory attention and working memory, visual attention and executive function, and mental flexibility.

Higher attention and executive function scores were moderately correlated with a lower sleep score in the transdermal group (r = –0.54, a significant difference compared with the oral formulation). Lower sleep scores also showed a moderate correlation with preserved cortical volume of the dorsolateral prefrontal region (r = –0.47, also significantly different from the oral group).

Lower brain amyloid also positively correlated with better sleep. The correlation between sleep and global amyloid burden in the transdermal group was also moderate (r = 0.45), while the correlation in the oral group was significantly weaker (r = 0.18).

“We can say that sleep quality and transdermal estradiol during early postmenopausal years somehow interact to influence beta-amyloid deposition, preservation of dorsolateral prefrontal cortex volume, and attention and executive function,” Dr. Zeydan said.

Dr. Zeydan had no financial disclosures.

[email protected]

*Correction, 8/7/2019: An earlier version of this story did not make clear that participants in the control group received oral placebo and a placebo patch.

The number of pregnancies among women taking isotretinoin has decreased since the introduction of the iPledge program, but pregnancy, abortions, and fetal defects associated with isotretinoin exposure are still occurring in women of reproductive age, according to a retrospective study published in JAMA Dermatology.

In 2006, the Food and Drug Administration implemented the iPledge program, with requirements that include women of childbearing age having a negative pregnancy test and evidence of using two forms of contraception monthly to use isotretinoin, a teratogen. “Although the number of pregnancy-related adverse events for patients taking isotretinoin has decreased since 2006, pregnancies, abortions, and fetal defects associated with isotretinoin exposure continue to be a problem,” Elizabeth Tkachenko, BS, from the University of Massachusetts Medical School, Worcester, and coauthors concluded. “Further research is required to determine the most efficacious system to reduce complications for patients and administrative requirements for physicians while at the same time maintaining access to this important drug.” (iPledge followed other Risk Evaluation and Mitigation Strategy systems for isotretinoin.)

She and her colleagues performed a retrospective evaluation of pregnancy-related adverse events related to isotretinoin that had occurred between January 1997 and December 2017 using the FDA Adverse Event Reporting System (FAERS), which receives reports from prescribers, consumers, and pharmaceutical manufacturers. While there could be many different classification terms for each individual, any number of adverse events reported by an individual was counted as one pregnancy. Ms. Tkachenko and colleagues classified abortions, pregnancies during contraception use, and pregnancy-related defects into separate subgroups for analysis.

From 1997 to 2017, there were 6,740 pregnancies among women (mean age, 24.6 years) during treatment with isotretinoin reported to FAERS, with 7 reports in 1997, and a peak of 768 pregnancies in 2006. Almost 70% (4,647) of the pregnancies were reported after iPledge was introduced. Between 2011 and 2017, there were 218-310 pregnancy reports each year.

Of the total number of pregnancy reports during the study period, 1,896 were abortions (28.1% of the total); 10.9% of the total number of pregnancy reports were spontaneous abortions (733). The number of abortions peaked in 2008, with 291 reports, of which 85% were therapeutic abortions. Also peaking in 2008 was the number of reports of pregnancies while taking a contraceptive (64). After 2008, pregnancies and abortions dropped.

Fetal defects peaked in 2000, with 34 cases reported, and dropped to four or fewer reports annually after 2008.

“Our findings demonstrate that reports of pregnancy among women taking isotretinoin are concentrated among those aged 20 to 29 years, peaked in 2006, and have been consistent since 2011,” the authors wrote.

Limitations of the study, they noted, include limitations of FAERS data and possible reporting fatigue among doctors and patients. The total number of isotretinoin courses prescribed to this patient population is also unknown, which affected their ability to determine the true rate of pregnancy-related adverse events, they noted.

The other authors for this study were from Harvard Medical School and the departments of dermatology at Brigham and Women’s Hospital, both in Boston, as well as the University of Pennsylvania, Philadelphia. One author reported support from an award by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and salary support from a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the trustees of the University of Pennsylvania. The other authors reported no relevant conflicts of interest.

SOURCE: Tkachenko E et al. JAMA Dermatol. 2019. doi: 10.1001/jamadermatol.2019.1388.

The number of pregnancies among women taking isotretinoin has decreased since the introduction of the iPledge program, but pregnancy, abortions, and fetal defects associated with isotretinoin exposure are still occurring in women of reproductive age, according to a retrospective study published in JAMA Dermatology.

In 2006, the Food and Drug Administration implemented the iPledge program, with requirements that include women of childbearing age having a negative pregnancy test and evidence of using two forms of contraception monthly to use isotretinoin, a teratogen. “Although the number of pregnancy-related adverse events for patients taking isotretinoin has decreased since 2006, pregnancies, abortions, and fetal defects associated with isotretinoin exposure continue to be a problem,” Elizabeth Tkachenko, BS, from the University of Massachusetts Medical School, Worcester, and coauthors concluded. “Further research is required to determine the most efficacious system to reduce complications for patients and administrative requirements for physicians while at the same time maintaining access to this important drug.” (iPledge followed other Risk Evaluation and Mitigation Strategy systems for isotretinoin.)

She and her colleagues performed a retrospective evaluation of pregnancy-related adverse events related to isotretinoin that had occurred between January 1997 and December 2017 using the FDA Adverse Event Reporting System (FAERS), which receives reports from prescribers, consumers, and pharmaceutical manufacturers. While there could be many different classification terms for each individual, any number of adverse events reported by an individual was counted as one pregnancy. Ms. Tkachenko and colleagues classified abortions, pregnancies during contraception use, and pregnancy-related defects into separate subgroups for analysis.

From 1997 to 2017, there were 6,740 pregnancies among women (mean age, 24.6 years) during treatment with isotretinoin reported to FAERS, with 7 reports in 1997, and a peak of 768 pregnancies in 2006. Almost 70% (4,647) of the pregnancies were reported after iPledge was introduced. Between 2011 and 2017, there were 218-310 pregnancy reports each year.

Of the total number of pregnancy reports during the study period, 1,896 were abortions (28.1% of the total); 10.9% of the total number of pregnancy reports were spontaneous abortions (733). The number of abortions peaked in 2008, with 291 reports, of which 85% were therapeutic abortions. Also peaking in 2008 was the number of reports of pregnancies while taking a contraceptive (64). After 2008, pregnancies and abortions dropped.

Fetal defects peaked in 2000, with 34 cases reported, and dropped to four or fewer reports annually after 2008.

“Our findings demonstrate that reports of pregnancy among women taking isotretinoin are concentrated among those aged 20 to 29 years, peaked in 2006, and have been consistent since 2011,” the authors wrote.

Limitations of the study, they noted, include limitations of FAERS data and possible reporting fatigue among doctors and patients. The total number of isotretinoin courses prescribed to this patient population is also unknown, which affected their ability to determine the true rate of pregnancy-related adverse events, they noted.

The other authors for this study were from Harvard Medical School and the departments of dermatology at Brigham and Women’s Hospital, both in Boston, as well as the University of Pennsylvania, Philadelphia. One author reported support from an award by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and salary support from a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the trustees of the University of Pennsylvania. The other authors reported no relevant conflicts of interest.

SOURCE: Tkachenko E et al. JAMA Dermatol. 2019. doi: 10.1001/jamadermatol.2019.1388.

The number of pregnancies among women taking isotretinoin has decreased since the introduction of the iPledge program, but pregnancy, abortions, and fetal defects associated with isotretinoin exposure are still occurring in women of reproductive age, according to a retrospective study published in JAMA Dermatology.

In 2006, the Food and Drug Administration implemented the iPledge program, with requirements that include women of childbearing age having a negative pregnancy test and evidence of using two forms of contraception monthly to use isotretinoin, a teratogen. “Although the number of pregnancy-related adverse events for patients taking isotretinoin has decreased since 2006, pregnancies, abortions, and fetal defects associated with isotretinoin exposure continue to be a problem,” Elizabeth Tkachenko, BS, from the University of Massachusetts Medical School, Worcester, and coauthors concluded. “Further research is required to determine the most efficacious system to reduce complications for patients and administrative requirements for physicians while at the same time maintaining access to this important drug.” (iPledge followed other Risk Evaluation and Mitigation Strategy systems for isotretinoin.)

She and her colleagues performed a retrospective evaluation of pregnancy-related adverse events related to isotretinoin that had occurred between January 1997 and December 2017 using the FDA Adverse Event Reporting System (FAERS), which receives reports from prescribers, consumers, and pharmaceutical manufacturers. While there could be many different classification terms for each individual, any number of adverse events reported by an individual was counted as one pregnancy. Ms. Tkachenko and colleagues classified abortions, pregnancies during contraception use, and pregnancy-related defects into separate subgroups for analysis.

From 1997 to 2017, there were 6,740 pregnancies among women (mean age, 24.6 years) during treatment with isotretinoin reported to FAERS, with 7 reports in 1997, and a peak of 768 pregnancies in 2006. Almost 70% (4,647) of the pregnancies were reported after iPledge was introduced. Between 2011 and 2017, there were 218-310 pregnancy reports each year.

Of the total number of pregnancy reports during the study period, 1,896 were abortions (28.1% of the total); 10.9% of the total number of pregnancy reports were spontaneous abortions (733). The number of abortions peaked in 2008, with 291 reports, of which 85% were therapeutic abortions. Also peaking in 2008 was the number of reports of pregnancies while taking a contraceptive (64). After 2008, pregnancies and abortions dropped.

Fetal defects peaked in 2000, with 34 cases reported, and dropped to four or fewer reports annually after 2008.

“Our findings demonstrate that reports of pregnancy among women taking isotretinoin are concentrated among those aged 20 to 29 years, peaked in 2006, and have been consistent since 2011,” the authors wrote.

Limitations of the study, they noted, include limitations of FAERS data and possible reporting fatigue among doctors and patients. The total number of isotretinoin courses prescribed to this patient population is also unknown, which affected their ability to determine the true rate of pregnancy-related adverse events, they noted.

The other authors for this study were from Harvard Medical School and the departments of dermatology at Brigham and Women’s Hospital, both in Boston, as well as the University of Pennsylvania, Philadelphia. One author reported support from an award by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and salary support from a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the trustees of the University of Pennsylvania. The other authors reported no relevant conflicts of interest.

SOURCE: Tkachenko E et al. JAMA Dermatol. 2019. doi: 10.1001/jamadermatol.2019.1388.

Children whose mothers were exposed to the pandemic H1N1 influenza vaccine during pregnancy do not have notably different health outcomes at the age of 5 years, according to Laura K. Walsh of the University of Ottawa and associates.

Piotr Marcinski/Thinkstock

The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.

After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).

No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).

“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.

The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
 

[email protected]

Children whose mothers were exposed to the pandemic H1N1 influenza vaccine during pregnancy do not have notably different health outcomes at the age of 5 years, according to Laura K. Walsh of the University of Ottawa and associates.

Piotr Marcinski/Thinkstock

The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.

After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).

No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).

“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.

The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
 

[email protected]

Children whose mothers were exposed to the pandemic H1N1 influenza vaccine during pregnancy do not have notably different health outcomes at the age of 5 years, according to Laura K. Walsh of the University of Ottawa and associates.

Piotr Marcinski/Thinkstock

The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.

After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).

No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).

“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.

The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
 

[email protected]

Sexually active adolescent girls face reproductive coercion (RC) and adolescent relationship abuse (ARA), but there seems to be no statistically significant demographic factors, so education should be universally provided, wrote Amber L. Hill, MSPH, and colleagues in Obstetrics & Gynecology.

Juanmonino/iStock/Getty Images Plus

Ms. Hill of the University of Pittsburgh and colleagues conducted a secondary analysis of data from a cross-sectional baseline survey that had been used in a cluster-randomized trial. The SHARP (School Health Center Healthy Adolescent Relationship Program) trial, investigated an educational intervention regarding healthy relationships. Their analysis included survey data for 550 sexually active girls aged 14-19 years who’d received services from any of eight student health centers across Northern California during the 2012-2013 school year.

The investigators explained that ARA includes physical, sexual, and emotional abuse among adolescents in a romantic relationship; they further described RC as a form of ARA that increases risks of unintended pregnancy, such as contraceptive sabotage, condom manipulation, and pregnancy coercion. RC was defined as a positive response on a 10-item validated measure, and ARA was defined by positive response to at least one of three items that had been derived from Conflict Tactics Scale 2 and the Sexual Experiences Survey.

Among all females in the analysis, 12% reported reproductive coercion, and 17% reported relationship abuse . Black and Hispanic girls were the most likely to report RC, each at 15%; white girls were the most likely to report ARA at 22%. However, none of the demographic differences evaluated in this analysis, including these, were statistically significant, the authors cautioned.

One of the limitations of this study is that its sample was limited to school health centers in Northern California so it may not be generalizable. Furthermore, its cross-sectional design limits causal inference.

“By highlighting the relevance of reproductive coercion in adolescence, this study substantiates the urgent need for developmentally appropriate interventions,” Ms. Hill and associates concluded.

The authors did not report any potential conflicts of interest. Grants from the National Institute of Justice, Office of Justice Programs, U.S. Department of Justice and the National Center for Advancing Translational Sciences of the National Institutes of Health supported the study.

[email protected]

SOURCE: Hill AL et al. Obstet Gynecol. 2019;134(2):351-9.

Sexually active adolescent girls face reproductive coercion (RC) and adolescent relationship abuse (ARA), but there seems to be no statistically significant demographic factors, so education should be universally provided, wrote Amber L. Hill, MSPH, and colleagues in Obstetrics & Gynecology.

Juanmonino/iStock/Getty Images Plus

Ms. Hill of the University of Pittsburgh and colleagues conducted a secondary analysis of data from a cross-sectional baseline survey that had been used in a cluster-randomized trial. The SHARP (School Health Center Healthy Adolescent Relationship Program) trial, investigated an educational intervention regarding healthy relationships. Their analysis included survey data for 550 sexually active girls aged 14-19 years who’d received services from any of eight student health centers across Northern California during the 2012-2013 school year.

The investigators explained that ARA includes physical, sexual, and emotional abuse among adolescents in a romantic relationship; they further described RC as a form of ARA that increases risks of unintended pregnancy, such as contraceptive sabotage, condom manipulation, and pregnancy coercion. RC was defined as a positive response on a 10-item validated measure, and ARA was defined by positive response to at least one of three items that had been derived from Conflict Tactics Scale 2 and the Sexual Experiences Survey.

Among all females in the analysis, 12% reported reproductive coercion, and 17% reported relationship abuse . Black and Hispanic girls were the most likely to report RC, each at 15%; white girls were the most likely to report ARA at 22%. However, none of the demographic differences evaluated in this analysis, including these, were statistically significant, the authors cautioned.

One of the limitations of this study is that its sample was limited to school health centers in Northern California so it may not be generalizable. Furthermore, its cross-sectional design limits causal inference.

“By highlighting the relevance of reproductive coercion in adolescence, this study substantiates the urgent need for developmentally appropriate interventions,” Ms. Hill and associates concluded.

The authors did not report any potential conflicts of interest. Grants from the National Institute of Justice, Office of Justice Programs, U.S. Department of Justice and the National Center for Advancing Translational Sciences of the National Institutes of Health supported the study.

[email protected]

SOURCE: Hill AL et al. Obstet Gynecol. 2019;134(2):351-9.

Sexually active adolescent girls face reproductive coercion (RC) and adolescent relationship abuse (ARA), but there seems to be no statistically significant demographic factors, so education should be universally provided, wrote Amber L. Hill, MSPH, and colleagues in Obstetrics & Gynecology.

Juanmonino/iStock/Getty Images Plus

Ms. Hill of the University of Pittsburgh and colleagues conducted a secondary analysis of data from a cross-sectional baseline survey that had been used in a cluster-randomized trial. The SHARP (School Health Center Healthy Adolescent Relationship Program) trial, investigated an educational intervention regarding healthy relationships. Their analysis included survey data for 550 sexually active girls aged 14-19 years who’d received services from any of eight student health centers across Northern California during the 2012-2013 school year.

The investigators explained that ARA includes physical, sexual, and emotional abuse among adolescents in a romantic relationship; they further described RC as a form of ARA that increases risks of unintended pregnancy, such as contraceptive sabotage, condom manipulation, and pregnancy coercion. RC was defined as a positive response on a 10-item validated measure, and ARA was defined by positive response to at least one of three items that had been derived from Conflict Tactics Scale 2 and the Sexual Experiences Survey.

Among all females in the analysis, 12% reported reproductive coercion, and 17% reported relationship abuse . Black and Hispanic girls were the most likely to report RC, each at 15%; white girls were the most likely to report ARA at 22%. However, none of the demographic differences evaluated in this analysis, including these, were statistically significant, the authors cautioned.

One of the limitations of this study is that its sample was limited to school health centers in Northern California so it may not be generalizable. Furthermore, its cross-sectional design limits causal inference.

“By highlighting the relevance of reproductive coercion in adolescence, this study substantiates the urgent need for developmentally appropriate interventions,” Ms. Hill and associates concluded.

The authors did not report any potential conflicts of interest. Grants from the National Institute of Justice, Office of Justice Programs, U.S. Department of Justice and the National Center for Advancing Translational Sciences of the National Institutes of Health supported the study.

[email protected]

SOURCE: Hill AL et al. Obstet Gynecol. 2019;134(2):351-9.

About 7% of women who receive opioid painkillers after even minor gynecological surgeries are getting fresh opioid prescriptions months later – showing that persistent opioid use can follow such surgeries.

©BananaStock/thinkstockphotos.com

For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.

Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).

Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.

“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”

Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”

Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.

Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.

SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.

About 7% of women who receive opioid painkillers after even minor gynecological surgeries are getting fresh opioid prescriptions months later – showing that persistent opioid use can follow such surgeries.

©BananaStock/thinkstockphotos.com

For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.

Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).

Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.

“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”

Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”

Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.

Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.

SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.

About 7% of women who receive opioid painkillers after even minor gynecological surgeries are getting fresh opioid prescriptions months later – showing that persistent opioid use can follow such surgeries.

©BananaStock/thinkstockphotos.com

For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.

Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).

Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.

“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”

Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”

Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.

Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.

SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.

The presence of cathepsin Z messenger RNA in peripheral blood mononuclear cells of people with osteopenia, osteoporosis, and women with osteoporosis and older than 50 years could be used as a biomarker to help diagnose osteoporosis, according to a recent study published in Scientific Reports.

Dong L. Barraclough, PhD, of the Institute of Ageing and Chronic Disease at the University of Liverpool, England, and colleagues studied the expression of cathepsin Z messenger RNA (mRNA) in peripheral blood mononuclear cells (PBMCs) of 88 participants (71 women, 17 men). The participants were grouped according to their bone mineral density and T score, where a T score of −1.0 or higher was considered nonosteoporotic, a score between −1.0 and −2.5 was classified as osteopenia, and −2.5 or less was classified as osteoporosis.

Overall, there were 48 participants with osteopenia (38 women, 10 men; 55% of total participants; average age, 65 years), 23 participants with osteoporosis (19 women, 4 men; 26%; 69 years), and 17 participants in the nonosteoporotic control group (14 women, 3 men; 19%; 56 years), with 88% of the total number of participants aged 50 years and older (82% women, 18% men).

The researchers found significantly higher differential expression of cathepsin Z mRNA in PBMCs when comparing the nonosteoporotic control group and participants with osteopenia (95% confidence interval, −0.32 to −0.053; P = .0067), the control group with participants with osteoporosis (95% CI, −0.543 to −0.24; P less than .0001), and participants with osteopenia and those with osteoporosis (95% CI, −0.325 to −0.084; P = .0011).

That association also was seen in women with osteoporosis who were older than 50 years (P = .0016) and did not change when participants were excluded for receiving treatment for osteoporosis, the authors wrote.

There also was an inverse association between cathepsin Z mRNA levels and bone mineral density (P = .0149) as well as inversely associated with lumbar spine L2-L4 and femoral neck T-scores (P = .0002 and P = .0139, respectively) and fragility fracture (P = .0018) in participants with osteopenia, osteoporosis, and women with osteoporosis older than 50 years.

Patients with chronic inflammatory disease sometimes have “osteoporosis-like conditions,” the authors noted. “However, there was no significant difference in cathepsin Z mRNA levels between osteopenia and osteoporosis patients who were also suffering from chronic inflammatory disorders and those [who] were not,” either when all osteopenia and osteoporosis participants were included (P = .774), or when only women participants with osteopenia or osteoporosis and older than 50 years were included (P = .666).


“The observation that [participants] with osteopenia also showed a significant increase in cathepsin Z mRNA, compared [with] nonosteoporotic controls, strongly suggests that, if replicated in a larger study, the cathepsin Z mRNA in patients’ PBMC preparations could form the basis of a test for osteoporosis, which could aid in the detection of osteoporosis before a critical and expensive fragility fracture occurs,” the authors wrote.

The authors reported no relevant conflicts of interest.
 

SOURCE: Dera AA et al. Sci Rep. 2019 Jul 5. doi: 10.1038/s41598-019-46068-0.

The presence of cathepsin Z messenger RNA in peripheral blood mononuclear cells of people with osteopenia, osteoporosis, and women with osteoporosis and older than 50 years could be used as a biomarker to help diagnose osteoporosis, according to a recent study published in Scientific Reports.

Dong L. Barraclough, PhD, of the Institute of Ageing and Chronic Disease at the University of Liverpool, England, and colleagues studied the expression of cathepsin Z messenger RNA (mRNA) in peripheral blood mononuclear cells (PBMCs) of 88 participants (71 women, 17 men). The participants were grouped according to their bone mineral density and T score, where a T score of −1.0 or higher was considered nonosteoporotic, a score between −1.0 and −2.5 was classified as osteopenia, and −2.5 or less was classified as osteoporosis.

Overall, there were 48 participants with osteopenia (38 women, 10 men; 55% of total participants; average age, 65 years), 23 participants with osteoporosis (19 women, 4 men; 26%; 69 years), and 17 participants in the nonosteoporotic control group (14 women, 3 men; 19%; 56 years), with 88% of the total number of participants aged 50 years and older (82% women, 18% men).

The researchers found significantly higher differential expression of cathepsin Z mRNA in PBMCs when comparing the nonosteoporotic control group and participants with osteopenia (95% confidence interval, −0.32 to −0.053; P = .0067), the control group with participants with osteoporosis (95% CI, −0.543 to −0.24; P less than .0001), and participants with osteopenia and those with osteoporosis (95% CI, −0.325 to −0.084; P = .0011).

That association also was seen in women with osteoporosis who were older than 50 years (P = .0016) and did not change when participants were excluded for receiving treatment for osteoporosis, the authors wrote.

There also was an inverse association between cathepsin Z mRNA levels and bone mineral density (P = .0149) as well as inversely associated with lumbar spine L2-L4 and femoral neck T-scores (P = .0002 and P = .0139, respectively) and fragility fracture (P = .0018) in participants with osteopenia, osteoporosis, and women with osteoporosis older than 50 years.

Patients with chronic inflammatory disease sometimes have “osteoporosis-like conditions,” the authors noted. “However, there was no significant difference in cathepsin Z mRNA levels between osteopenia and osteoporosis patients who were also suffering from chronic inflammatory disorders and those [who] were not,” either when all osteopenia and osteoporosis participants were included (P = .774), or when only women participants with osteopenia or osteoporosis and older than 50 years were included (P = .666).


“The observation that [participants] with osteopenia also showed a significant increase in cathepsin Z mRNA, compared [with] nonosteoporotic controls, strongly suggests that, if replicated in a larger study, the cathepsin Z mRNA in patients’ PBMC preparations could form the basis of a test for osteoporosis, which could aid in the detection of osteoporosis before a critical and expensive fragility fracture occurs,” the authors wrote.

The authors reported no relevant conflicts of interest.
 

SOURCE: Dera AA et al. Sci Rep. 2019 Jul 5. doi: 10.1038/s41598-019-46068-0.

The presence of cathepsin Z messenger RNA in peripheral blood mononuclear cells of people with osteopenia, osteoporosis, and women with osteoporosis and older than 50 years could be used as a biomarker to help diagnose osteoporosis, according to a recent study published in Scientific Reports.

Dong L. Barraclough, PhD, of the Institute of Ageing and Chronic Disease at the University of Liverpool, England, and colleagues studied the expression of cathepsin Z messenger RNA (mRNA) in peripheral blood mononuclear cells (PBMCs) of 88 participants (71 women, 17 men). The participants were grouped according to their bone mineral density and T score, where a T score of −1.0 or higher was considered nonosteoporotic, a score between −1.0 and −2.5 was classified as osteopenia, and −2.5 or less was classified as osteoporosis.

Overall, there were 48 participants with osteopenia (38 women, 10 men; 55% of total participants; average age, 65 years), 23 participants with osteoporosis (19 women, 4 men; 26%; 69 years), and 17 participants in the nonosteoporotic control group (14 women, 3 men; 19%; 56 years), with 88% of the total number of participants aged 50 years and older (82% women, 18% men).

The researchers found significantly higher differential expression of cathepsin Z mRNA in PBMCs when comparing the nonosteoporotic control group and participants with osteopenia (95% confidence interval, −0.32 to −0.053; P = .0067), the control group with participants with osteoporosis (95% CI, −0.543 to −0.24; P less than .0001), and participants with osteopenia and those with osteoporosis (95% CI, −0.325 to −0.084; P = .0011).

That association also was seen in women with osteoporosis who were older than 50 years (P = .0016) and did not change when participants were excluded for receiving treatment for osteoporosis, the authors wrote.

There also was an inverse association between cathepsin Z mRNA levels and bone mineral density (P = .0149) as well as inversely associated with lumbar spine L2-L4 and femoral neck T-scores (P = .0002 and P = .0139, respectively) and fragility fracture (P = .0018) in participants with osteopenia, osteoporosis, and women with osteoporosis older than 50 years.

Patients with chronic inflammatory disease sometimes have “osteoporosis-like conditions,” the authors noted. “However, there was no significant difference in cathepsin Z mRNA levels between osteopenia and osteoporosis patients who were also suffering from chronic inflammatory disorders and those [who] were not,” either when all osteopenia and osteoporosis participants were included (P = .774), or when only women participants with osteopenia or osteoporosis and older than 50 years were included (P = .666).


“The observation that [participants] with osteopenia also showed a significant increase in cathepsin Z mRNA, compared [with] nonosteoporotic controls, strongly suggests that, if replicated in a larger study, the cathepsin Z mRNA in patients’ PBMC preparations could form the basis of a test for osteoporosis, which could aid in the detection of osteoporosis before a critical and expensive fragility fracture occurs,” the authors wrote.

The authors reported no relevant conflicts of interest.
 

SOURCE: Dera AA et al. Sci Rep. 2019 Jul 5. doi: 10.1038/s41598-019-46068-0.

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

Severe maternal morbidity is almost five times more common in women who have stillbirth deliveries than in women who have live births, according to research in Obstetrics & Gynecology.

JazzIRT/Getty Images

Citing major increases in risk for a host of serious complications, the authors of the large population-based study urge those caring for women experiencing stillbirth to be vigilant for trouble.

Severe maternal morbidity among mothers experiencing stillbirth occurred in 578 cases per 10,000 deliveries, compared with 99 cases per 10,000 live deliveries, wrote Elizabeth Wall-Wieler, PhD, and coauthors. After statistical adjustment, the relative risk (RR) for severe maternal morbidity in a stillbirth compared with a live delivery was 4.77 (95% confidence interval, 4.53-5.02).

“Our findings indicate that nearly 1 in 17 women who deliver a stillbirth in California experience severe maternal morbidity. Furthermore, the risk of severe maternal morbidity was more than fourfold higher for women undergoing stillbirth delivery than live birth delivery,” the investigators wrote.

Major maternal organ dysfunction or failure – including acute renal failure, adult respiratory distress syndrome, disseminated intravascular coagulation, sepsis, or shock – all were more common in stillbirth deliveries, noted Dr. Wall-Wieler and colleagues. Hysterectomy, likely performed to control major loss of blood, also was more likely in stillbirth deliveries.

“Minimal attention has been given to maternal outcomes and acute complications experienced by women who have a stillbirth,” wrote Dr. Wall-Wieler, a postdoctoral research fellow in developmental and neonatal medicine, and colleagues at Stanford (Calif.) University. This is so because many analyses of maternal morbidity exclude stillbirth deliveries, or lump them with term deliveries, she and coauthors explained.

Using data from the Office of Statewide Health Planning and Development in California, Dr. Wall-Wieler and colleagues examined a total of 6,459,842 deliveries occurring in the state during 1999-2011; of these, 25,997 (0.4%) were stillbirths. For the cross-sectional study, the investigators included only deliveries for which fetal or neonatal vital records could be linked with the maternal hospital record.

Stillbirth was defined in the study as a fetal death delivered at or after 20 weeks’ gestation, so deliveries at less than 20 weeks’ gestation were excluded, as were any deliveries recorded as being at or after 45 weeks’ gestation, because the latter set were considered likely to be data entry errors.

Deliveries were considered to have severe maternal morbidity if any of the 18 indicators identified by the Centers for Disease Control and Prevention were coded in the medical record. The most common severe morbidities seen in stillbirth were blood transfusion, disseminated intravascular coagulation, and acute renal failure (adjusted RRs 5.38, 8.78, and 13.22, respectively). Although absolute occurrences were less frequent, relative risk for sepsis and shock were more than 14 times higher for stillbirths than for live birth deliveries.

“Taken together, these findings suggest the morbidity associated with obstetric hemorrhage and preeclampsia among women hospitalized for stillbirth delivery is a serious concern,” wrote Dr. Wall-Wieler and coauthors. They called for prospective studies to clarify cause and effect between stillbirth and these morbidities and to look into whether women carrying a nonviable fetus or with known fetal demise are managed differently than those with a viable fetus.

Overall, stillbirth deliveries were more likely for women who were older, for non-Hispanic black women, for those who did not have a college education, and those who did not have private insurance. Preexisting diabetes and hypertension, as well as a vaginal delivery, also upped the risk for stillbirth.

For reasons that are not completely clear, the risk for severe maternal morbidity with stillbirth climbed after 30 weeks’ gestation. Dr. Wall-Wieler and collaborators conducted an exploratory analysis that dichotomized deliveries for both stillbirth and live births into those occurring at fewer than 30 weeks’ gestation, or at or after 30 weeks’. They found no increased risk for severe maternal morbidity earlier than 30 weeks, but an RR of 5.4 for stillbirth at or after 30 weeks.

A reported cause of fetal demise was available for 71% of deliveries, with umbilical cord anomalies, obstetric complications, and placental conditions collectively accounting for almost half (46%) of the identified causes of demise. Severe maternal morbidity was most common in deaths related to hypertensive disorders, at 24/100, and least common in deaths from major fetal structural or genetic problems, at 1/100.

The size of the study strengthens the findings, said the investigators, but the large amount of missing data in recording fetal deaths does introduce some limitations. These include the inability to distinguish between intrapartum and antepartum fetal death, as well as the fact that cause of fetal death was not recorded for over one in four stillbirths.

“Given the recent calls to reduce the national rate of severe maternal morbidity, new public health initiatives and practice guidelines are needed to highlight and address the morbidity risk associated with stillbirth identified in this study,” wrote Dr. Wall-Wieler and colleagues.

The study was funded by the National Institutes of Health and by Stanford University. Ronald S. Gibbs, MD, reported receiving money from Novavax/ACI. Alexander J. Butwick, MD, reported receiving money from Cerus Corp. and Instrumentation Laboratory. The other coauthors reported no relevant financial conflicts of interest.

[email protected]

SOURCE: Wall-Wieler E et al. Obstet Gynecol. 2019 Aug. 134:2;310-7.

There has been little to no recent improvement in the large share of cancer patients who are not receiving detailed information about survivorship care, suggests a nationally representative cross-sectional survey.

In 2006, the Institute of Medicine issued a seminal report recommending survivorship care planning to address the special needs of this patient population, noted the investigators, led by Ashish Rai, PhD, American Cancer Society, Framingham, Mass. Other organizations have since issued guidelines and policies in this area.

For the study, Dr. Rai and colleagues analyzed data from 2,266 survivors who completed the 2011 or 2016 Medical Expenditure Panel Survey – Experiences with Cancer questionnaire. Survivors were asked whether any clinician had ever discussed various aspects of survivorship care; responses were dichotomized as having had detailed discussion versus not (brief or no discussion, or not remembering).

Between 2011 and 2016, there was minimal change in the percentage of survivors who reported not receiving detailed information on follow-up care (from 35.1% to 35.4%), late or long-term adverse effects (from 54.2% to 55.5%), lifestyle recommendations (from 58.9% to 57.8%), and emotional or social needs (from 69.2% to 68.2%), the investigators wrote. Their report is in Journal of Oncology Practice.

When analyses were restricted to only those survivors who had received cancer-directed treatment within 3 years of the survey, findings were essentially the same.

About one-quarter of survivors reported having detailed discussions about all four topics in both 2011 (24.4%) and 2016 (21.9%).

In 2016, nearly half of survivors, 47.6%, reported not having detailed discussions with their providers about a summary of their cancer treatments. (This question was not asked in 2011.)

“Despite national efforts and organizations promoting survivorship care planning and highlighting the need for improved quality of survivorship care delivery, clear gaps in quality of communication between survivors of cancer and providers persist,” Dr. Rai and colleagues said.

“Continued efforts are needed to promote communication about survivorship issues, including implementation and evaluation of targeted interventions in key survivorship care areas,” they recommended. “These interventions may consist of furnishing guidance on optimal ways to identify and address survivors’ communication needs, streamlining the flow of information across provider types, ensuring better integration of primary care providers with the survivorship care paradigm, and augmenting the use of health information technology for collection and dissemination of information across the cancer control continuum.”

Dr. Rai did not disclose any relevant conflicts of interest. The study did not receive specific funding.

SOURCE: Rai A et al. J Oncol Pract. 2019 July 2. doi: 10.1200/JOP.19.00157.

There has been little to no recent improvement in the large share of cancer patients who are not receiving detailed information about survivorship care, suggests a nationally representative cross-sectional survey.

In 2006, the Institute of Medicine issued a seminal report recommending survivorship care planning to address the special needs of this patient population, noted the investigators, led by Ashish Rai, PhD, American Cancer Society, Framingham, Mass. Other organizations have since issued guidelines and policies in this area.

For the study, Dr. Rai and colleagues analyzed data from 2,266 survivors who completed the 2011 or 2016 Medical Expenditure Panel Survey – Experiences with Cancer questionnaire. Survivors were asked whether any clinician had ever discussed various aspects of survivorship care; responses were dichotomized as having had detailed discussion versus not (brief or no discussion, or not remembering).

Between 2011 and 2016, there was minimal change in the percentage of survivors who reported not receiving detailed information on follow-up care (from 35.1% to 35.4%), late or long-term adverse effects (from 54.2% to 55.5%), lifestyle recommendations (from 58.9% to 57.8%), and emotional or social needs (from 69.2% to 68.2%), the investigators wrote. Their report is in Journal of Oncology Practice.

When analyses were restricted to only those survivors who had received cancer-directed treatment within 3 years of the survey, findings were essentially the same.

About one-quarter of survivors reported having detailed discussions about all four topics in both 2011 (24.4%) and 2016 (21.9%).

In 2016, nearly half of survivors, 47.6%, reported not having detailed discussions with their providers about a summary of their cancer treatments. (This question was not asked in 2011.)

“Despite national efforts and organizations promoting survivorship care planning and highlighting the need for improved quality of survivorship care delivery, clear gaps in quality of communication between survivors of cancer and providers persist,” Dr. Rai and colleagues said.

“Continued efforts are needed to promote communication about survivorship issues, including implementation and evaluation of targeted interventions in key survivorship care areas,” they recommended. “These interventions may consist of furnishing guidance on optimal ways to identify and address survivors’ communication needs, streamlining the flow of information across provider types, ensuring better integration of primary care providers with the survivorship care paradigm, and augmenting the use of health information technology for collection and dissemination of information across the cancer control continuum.”

Dr. Rai did not disclose any relevant conflicts of interest. The study did not receive specific funding.

SOURCE: Rai A et al. J Oncol Pract. 2019 July 2. doi: 10.1200/JOP.19.00157.

There has been little to no recent improvement in the large share of cancer patients who are not receiving detailed information about survivorship care, suggests a nationally representative cross-sectional survey.

In 2006, the Institute of Medicine issued a seminal report recommending survivorship care planning to address the special needs of this patient population, noted the investigators, led by Ashish Rai, PhD, American Cancer Society, Framingham, Mass. Other organizations have since issued guidelines and policies in this area.

For the study, Dr. Rai and colleagues analyzed data from 2,266 survivors who completed the 2011 or 2016 Medical Expenditure Panel Survey – Experiences with Cancer questionnaire. Survivors were asked whether any clinician had ever discussed various aspects of survivorship care; responses were dichotomized as having had detailed discussion versus not (brief or no discussion, or not remembering).

Between 2011 and 2016, there was minimal change in the percentage of survivors who reported not receiving detailed information on follow-up care (from 35.1% to 35.4%), late or long-term adverse effects (from 54.2% to 55.5%), lifestyle recommendations (from 58.9% to 57.8%), and emotional or social needs (from 69.2% to 68.2%), the investigators wrote. Their report is in Journal of Oncology Practice.

When analyses were restricted to only those survivors who had received cancer-directed treatment within 3 years of the survey, findings were essentially the same.

About one-quarter of survivors reported having detailed discussions about all four topics in both 2011 (24.4%) and 2016 (21.9%).

In 2016, nearly half of survivors, 47.6%, reported not having detailed discussions with their providers about a summary of their cancer treatments. (This question was not asked in 2011.)

“Despite national efforts and organizations promoting survivorship care planning and highlighting the need for improved quality of survivorship care delivery, clear gaps in quality of communication between survivors of cancer and providers persist,” Dr. Rai and colleagues said.

“Continued efforts are needed to promote communication about survivorship issues, including implementation and evaluation of targeted interventions in key survivorship care areas,” they recommended. “These interventions may consist of furnishing guidance on optimal ways to identify and address survivors’ communication needs, streamlining the flow of information across provider types, ensuring better integration of primary care providers with the survivorship care paradigm, and augmenting the use of health information technology for collection and dissemination of information across the cancer control continuum.”

Dr. Rai did not disclose any relevant conflicts of interest. The study did not receive specific funding.

SOURCE: Rai A et al. J Oncol Pract. 2019 July 2. doi: 10.1200/JOP.19.00157.