Women's Health

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

New research from the University of Birmingham, England, in collaboration with the World Health Organization, shows that tocolytic drugs used to delay preterm birth, and thus avert the ensuing associated mortality and morbidity, are all “probably effective in delaying preterm birth compared with placebo or no treatment.”

Expanded use of the drugs would be a safe means to reduce the global burden of neonatal death, the researchers suggest. Coauthor Victoria Hodgetts Morton, BMedSci, NIHR clinical lecturer in obstetrics at the University of Birmingham, said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under 5 years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”
 

Network meta‐analysis drew on 122 trials

The new paper, published in Cochrane Reviews, aimed to find out which tocolytic was most effective in delaying preterm birth, safest, and with the fewest side effects. Researchers brought together data from 122 randomized clinical trials in a network meta‐analysis.

Unlike conventional Cochrane Reviews, this type of review simultaneously pools all direct and indirect evidence into one single coherent analysis. Indirect evidence is obtained by inferring the relative effectiveness of two competing drugs through a common comparator, even when these two drugs have not been directly compared. The method also enables researchers to calculate the probability for each competing drug to constitute the most effective drug with the least side effects. This thereby allowed the researchers to rank the available tocolytic drugs.

The trials, published between 1966 and 2021, involved 13,697 women across 39 countries and included high, middle and low-income states. The researchers looked for trials involving women with live fetus(es) who presented with signs and symptoms of preterm labor, defined as uterine activity with or without ruptured membranes; or ruptured membranes, with or without cervical dilatation or shortening or biomarkers consistent with a high risk of preterm birth.

Trials were eligible if they involved tocolytic drugs of any dosage, route, or regimen for delaying preterm birth, and compared them with other tocolytic drugs, placebo, or no treatment.

The team reported that overall, the evidence varied widely in quality, and their confidence in the effect estimates ranged from very low to high. Only 25 of the 122 studies (20%) were judged to be at “low risk of bias.” The effectiveness of different drugs was less clear in some of the studies considered.

Compared with the use of placebo or no tocolytic treatment, “all tocolytic drug classes assessed and their combinations were probably or possibly effective in delaying preterm birth for 48 hours, and 7 days,” the researchers found. “The most effective tocolytics for delaying preterm birth by 48 hours and 7 days were the nitric oxide donors, calcium channel blockers, oxytocin receptor antagonists, and combination tocolytics.”

Their figures showed:

• Betamimetics are possibly effective in delaying preterm birth by 48 hours (risk ratio [RR] 1.12), and 7 days (RR 1.14).
• Calcium channel blockers (for example, nifedipine) may be effective in delaying preterm birth by 48 hours (RR 1.16), and probably effective in delaying preterm birth by 7 days (RR 1.15), and prolong pregnancy by a mean of 5 days (0.1 to 9.2).
• Magnesium sulphate is probably effective in delaying preterm birth by 48 hours (RR 1.12).
• Oxytocin receptor antagonists (e.g., atosiban) are effective in delaying preterm birth by 7 days (RR 1.18), are probably effective in delaying preterm birth by 48 hours (RR 1.13), and possibly prolong pregnancy by an average of 10 days (95% confidence interval, 2.3 to 16.7).
• Nitric oxide donors (e.g., glyceryl trinitrate) are probably effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.18).
• Cyclooxygenase-2 inhibitors (e.g., indomethacin) may be effective in delaying preterm birth by 48 hours (RR 1.11).
• Combination tocolytics – most common was magnesium sulphate with betamimetics - are probably effective effective in delaying preterm birth by 48 hours (RR 1.17), and 7 days (RR 1.19).

Uncertain mortality outcomes and a wide range of adverse effects

However, the effects of tocolytic use on neonatal and perinatal mortality, and on safety outcomes such as maternal and neonatal infection, were “uncertain,” the researchers said, and the drugs proved compatible with a wide range of effects compared with placebo or no tocolytic treatment for these outcomes.

“All tocolytics were compatible with a wide range of serious adverse effects (trials including 6,983 women) when compared with placebo or no treatment,” the researchers said. Betamimetics and combination tocolytics had the most side effects and were most likely to lead to cessation of treatment (results from 8,122 women).

Overall, “the findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects,” said first author Amie Wilson, PhD, research fellow in global maternal health at the University of Birmingham. “These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length,” she said.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the U.K. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organisation on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

A version of this article first appeared on Medscape UK.

After 49 years of labor, abortion foes received the ultimate victory in June when the United States Supreme Court struck down a federal right to terminate pregnancy. Among those most heartened by the ruling was a small organization of doctors who specialize in women’s reproductive health. The group’s leader, while grateful for the win, isn’t ready for a curtain call. Instead, she sees her task as moving from a national stage to 50 regional ones.

The decision in Dobbs v. Jackson, which overturned a woman’s constitutional right to obtain an abortion, was the biggest but not final quarry for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). “It actually doesn’t change anything except to turn the whole discussion on abortion back to the states, which in our opinion is where it should have been 50 years ago,” Donna Harrison, MD, the group’s chief executive officer, said in a recent interview.

Dr. Harrison, an obstetrician-gynecologist and adjunct professor of bioethics at Trinity International University in Deerfield, Ind., said she was proud of “our small role in bringing science” to the top court’s attention, noting that the ruling incorporated some of AAPLOG’s medical arguments in reversing Roe v. Wade, the 1973 decision that created a right to abortion – and prompted her group’s founding. The ruling, for instance, agreed – in a departure from the generally accepted science – that a fetus is viable at 15 weeks, and the procedure is risky for mothers thereafter. “You could congratulate us for perseverance and for bringing that information, which has been in the peer-reviewed literature for a long time, to the justices’ attention,” she said.

Dr. Harrison said she was pleased that the Supreme Court agreed with the “science” that guided its decision to overturn Roe. That the court was willing to embrace that evidence troubles the American College of Obstetricians and Gynecologists (ACOG), the nation’s leading professional group for reproductive health experts.  
 

Defending the ‘second patient’

AAPLOG operates under the belief that life begins at the moment of fertilization, at which point “we defend the life of our second patient, the human being in the womb,” Dr. Harrison said. “For a very long time, ob.gyns. who valued both patients were not given a voice, and I think now we’re finding our voice.” The group will continue supporting abortion restrictions at the state level.

AAPLOG, with 6,000 members, was considered a “special interest” group within ACOG until the college discontinued such subgroups in 2013. ACOG, numbering 60,000 members, calls the Dobbs ruling “a huge step back for women and everyone who is seeking access to ob.gyn. care,” said Molly Meegan, JD, ACOG’s chief legal officer. Ms. Meegan expressed concern over the newfound influence of AAPLOG, which she called “a single-issue, single-topic, single-advocacy organization.”

Pro-choice groups, including ACOG, worry that the reversal of Roe has provided AAPLOG with an undeserved veneer of medical expertise. The decision also allowed judges and legislators to “insert themselves into nuanced and complex situations” they know little about and will rely on groups like AAPLOG to exert influence, Ms. Meegan said.

In turn, Dr. Harrison described ACOG as engaging in “rabid, pro-abortion activism.”

The number of abortions in the United States had steadily declined from a peak of 1.4 million per year in 1990 until 2017, after which it has risen slightly. In 2019, according to the U.S. Centers for Disease Control and Prevention, 625,000 abortions occurred nationally. Of those, 42.3% were medication abortions performed in the first 9 weeks, using a combination of the drugs mifepristone and misoprostol. Medication abortions now account for more than half of all pregnancy terminations in the United States, according to the Guttmacher Institute.

Dr. Harrison said that medication abortions put women at an elevated risk of serious, sometimes deadly bleeding, while ACOG points to evidence that the risk of childbirth to women is significantly higher. She also is no fan of Plan B, the “morning after” pill, which is available to women without having to consult a doctor. She described abortifacients as “a huge danger to women being harmed” by medications available over the counter.

In Dr. Harrison’s view, the 10-year-old Ohio girl who traveled to Indiana to obtain an abortion after she became pregnant as the result of rape should have continued her pregnancy. So, too, should young girls who are the victims of incest. “Incest is a horrific crime,” she said, “but aborting a girl because of incest doesn’t make her un-raped. It just adds another trauma.”

When told of Dr. Harrison’s comment, Ms. Meegan paused for 5 seconds before saying, “I think that statement speaks for itself.”

Louise Perkins King, MD, JD, an ob.gyn. and director of reproductive bioethics at Harvard Medical School, Boston, said she had the “horrific” experience of delivering a baby to an 11-year-old girl.

“Children are not fully developed, and they should not be having children,” Dr. King said.

Anne-Marie E. Amies Oelschlager, MD, vice chair of ACOG’s Clinical Consensus Committee and an ob.gyn. at Seattle Children’s in Washington, said in a statement that adolescents who are sexually assaulted are at extremely high risk of depression and posttraumatic stress disorder. “Do we expect a fourth-grader to carry a pregnancy to term, deliver, and expect that child to carry on after this horror?,” she asked.

Dr. Harrison dismissed such concerns. “Somehow abortion is a mental health treatment? Abortion doesn’t treat mental health problems,” she said. “Is there any proof that aborting in those circumstances improves their mental health? I would tell you there is very little research about it. …There are human beings involved, and this child who was raped, who also had a child, who was a human being, who is no longer.”  

Dr. Harrison said the Dobbs decision would have no effect on up to 93% of ob.gyns. who don’t perform abortions. Dr. King said the reason that most don’t perform the procedure is the “stigma” attached to abortion. “It’s still frowned upon,” she said. “We don’t talk about it as health care.”

Ms. Meegan added that ob.gyns. are fearful in the wake of the Dobbs decision because “they might find themselves subject to civil and criminal penalties.”

Dr. Harrison said that Roe was always a political decision and the science was always behind AAPLOG – something both Ms. Meegan and Dr. King dispute. Ms. Meegan and Dr. King said they are concerned about the chilling effects on both women and their clinicians, especially with laws that prevent referrals and travel to other states.

“You can’t compel me to give blood or bone marrow,” Dr. King said. “You can’t even compel me to give my hair for somebody, and you can’t compel me to give an organ. And all of a sudden when I’m pregnant, all my rights are out the window?”

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

After 49 years of labor, abortion foes received the ultimate victory in June when the United States Supreme Court struck down a federal right to terminate pregnancy. Among those most heartened by the ruling was a small organization of doctors who specialize in women’s reproductive health. The group’s leader, while grateful for the win, isn’t ready for a curtain call. Instead, she sees her task as moving from a national stage to 50 regional ones.

The decision in Dobbs v. Jackson, which overturned a woman’s constitutional right to obtain an abortion, was the biggest but not final quarry for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). “It actually doesn’t change anything except to turn the whole discussion on abortion back to the states, which in our opinion is where it should have been 50 years ago,” Donna Harrison, MD, the group’s chief executive officer, said in a recent interview.

Dr. Harrison, an obstetrician-gynecologist and adjunct professor of bioethics at Trinity International University in Deerfield, Ind., said she was proud of “our small role in bringing science” to the top court’s attention, noting that the ruling incorporated some of AAPLOG’s medical arguments in reversing Roe v. Wade, the 1973 decision that created a right to abortion – and prompted her group’s founding. The ruling, for instance, agreed – in a departure from the generally accepted science – that a fetus is viable at 15 weeks, and the procedure is risky for mothers thereafter. “You could congratulate us for perseverance and for bringing that information, which has been in the peer-reviewed literature for a long time, to the justices’ attention,” she said.

Dr. Harrison said she was pleased that the Supreme Court agreed with the “science” that guided its decision to overturn Roe. That the court was willing to embrace that evidence troubles the American College of Obstetricians and Gynecologists (ACOG), the nation’s leading professional group for reproductive health experts.  
 

Defending the ‘second patient’

AAPLOG operates under the belief that life begins at the moment of fertilization, at which point “we defend the life of our second patient, the human being in the womb,” Dr. Harrison said. “For a very long time, ob.gyns. who valued both patients were not given a voice, and I think now we’re finding our voice.” The group will continue supporting abortion restrictions at the state level.

AAPLOG, with 6,000 members, was considered a “special interest” group within ACOG until the college discontinued such subgroups in 2013. ACOG, numbering 60,000 members, calls the Dobbs ruling “a huge step back for women and everyone who is seeking access to ob.gyn. care,” said Molly Meegan, JD, ACOG’s chief legal officer. Ms. Meegan expressed concern over the newfound influence of AAPLOG, which she called “a single-issue, single-topic, single-advocacy organization.”

Pro-choice groups, including ACOG, worry that the reversal of Roe has provided AAPLOG with an undeserved veneer of medical expertise. The decision also allowed judges and legislators to “insert themselves into nuanced and complex situations” they know little about and will rely on groups like AAPLOG to exert influence, Ms. Meegan said.

In turn, Dr. Harrison described ACOG as engaging in “rabid, pro-abortion activism.”

The number of abortions in the United States had steadily declined from a peak of 1.4 million per year in 1990 until 2017, after which it has risen slightly. In 2019, according to the U.S. Centers for Disease Control and Prevention, 625,000 abortions occurred nationally. Of those, 42.3% were medication abortions performed in the first 9 weeks, using a combination of the drugs mifepristone and misoprostol. Medication abortions now account for more than half of all pregnancy terminations in the United States, according to the Guttmacher Institute.

Dr. Harrison said that medication abortions put women at an elevated risk of serious, sometimes deadly bleeding, while ACOG points to evidence that the risk of childbirth to women is significantly higher. She also is no fan of Plan B, the “morning after” pill, which is available to women without having to consult a doctor. She described abortifacients as “a huge danger to women being harmed” by medications available over the counter.

In Dr. Harrison’s view, the 10-year-old Ohio girl who traveled to Indiana to obtain an abortion after she became pregnant as the result of rape should have continued her pregnancy. So, too, should young girls who are the victims of incest. “Incest is a horrific crime,” she said, “but aborting a girl because of incest doesn’t make her un-raped. It just adds another trauma.”

When told of Dr. Harrison’s comment, Ms. Meegan paused for 5 seconds before saying, “I think that statement speaks for itself.”

Louise Perkins King, MD, JD, an ob.gyn. and director of reproductive bioethics at Harvard Medical School, Boston, said she had the “horrific” experience of delivering a baby to an 11-year-old girl.

“Children are not fully developed, and they should not be having children,” Dr. King said.

Anne-Marie E. Amies Oelschlager, MD, vice chair of ACOG’s Clinical Consensus Committee and an ob.gyn. at Seattle Children’s in Washington, said in a statement that adolescents who are sexually assaulted are at extremely high risk of depression and posttraumatic stress disorder. “Do we expect a fourth-grader to carry a pregnancy to term, deliver, and expect that child to carry on after this horror?,” she asked.

Dr. Harrison dismissed such concerns. “Somehow abortion is a mental health treatment? Abortion doesn’t treat mental health problems,” she said. “Is there any proof that aborting in those circumstances improves their mental health? I would tell you there is very little research about it. …There are human beings involved, and this child who was raped, who also had a child, who was a human being, who is no longer.”  

Dr. Harrison said the Dobbs decision would have no effect on up to 93% of ob.gyns. who don’t perform abortions. Dr. King said the reason that most don’t perform the procedure is the “stigma” attached to abortion. “It’s still frowned upon,” she said. “We don’t talk about it as health care.”

Ms. Meegan added that ob.gyns. are fearful in the wake of the Dobbs decision because “they might find themselves subject to civil and criminal penalties.”

Dr. Harrison said that Roe was always a political decision and the science was always behind AAPLOG – something both Ms. Meegan and Dr. King dispute. Ms. Meegan and Dr. King said they are concerned about the chilling effects on both women and their clinicians, especially with laws that prevent referrals and travel to other states.

“You can’t compel me to give blood or bone marrow,” Dr. King said. “You can’t even compel me to give my hair for somebody, and you can’t compel me to give an organ. And all of a sudden when I’m pregnant, all my rights are out the window?”

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

After 49 years of labor, abortion foes received the ultimate victory in June when the United States Supreme Court struck down a federal right to terminate pregnancy. Among those most heartened by the ruling was a small organization of doctors who specialize in women’s reproductive health. The group’s leader, while grateful for the win, isn’t ready for a curtain call. Instead, she sees her task as moving from a national stage to 50 regional ones.

The decision in Dobbs v. Jackson, which overturned a woman’s constitutional right to obtain an abortion, was the biggest but not final quarry for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). “It actually doesn’t change anything except to turn the whole discussion on abortion back to the states, which in our opinion is where it should have been 50 years ago,” Donna Harrison, MD, the group’s chief executive officer, said in a recent interview.

Dr. Harrison, an obstetrician-gynecologist and adjunct professor of bioethics at Trinity International University in Deerfield, Ind., said she was proud of “our small role in bringing science” to the top court’s attention, noting that the ruling incorporated some of AAPLOG’s medical arguments in reversing Roe v. Wade, the 1973 decision that created a right to abortion – and prompted her group’s founding. The ruling, for instance, agreed – in a departure from the generally accepted science – that a fetus is viable at 15 weeks, and the procedure is risky for mothers thereafter. “You could congratulate us for perseverance and for bringing that information, which has been in the peer-reviewed literature for a long time, to the justices’ attention,” she said.

Dr. Harrison said she was pleased that the Supreme Court agreed with the “science” that guided its decision to overturn Roe. That the court was willing to embrace that evidence troubles the American College of Obstetricians and Gynecologists (ACOG), the nation’s leading professional group for reproductive health experts.  
 

Defending the ‘second patient’

AAPLOG operates under the belief that life begins at the moment of fertilization, at which point “we defend the life of our second patient, the human being in the womb,” Dr. Harrison said. “For a very long time, ob.gyns. who valued both patients were not given a voice, and I think now we’re finding our voice.” The group will continue supporting abortion restrictions at the state level.

AAPLOG, with 6,000 members, was considered a “special interest” group within ACOG until the college discontinued such subgroups in 2013. ACOG, numbering 60,000 members, calls the Dobbs ruling “a huge step back for women and everyone who is seeking access to ob.gyn. care,” said Molly Meegan, JD, ACOG’s chief legal officer. Ms. Meegan expressed concern over the newfound influence of AAPLOG, which she called “a single-issue, single-topic, single-advocacy organization.”

Pro-choice groups, including ACOG, worry that the reversal of Roe has provided AAPLOG with an undeserved veneer of medical expertise. The decision also allowed judges and legislators to “insert themselves into nuanced and complex situations” they know little about and will rely on groups like AAPLOG to exert influence, Ms. Meegan said.

In turn, Dr. Harrison described ACOG as engaging in “rabid, pro-abortion activism.”

The number of abortions in the United States had steadily declined from a peak of 1.4 million per year in 1990 until 2017, after which it has risen slightly. In 2019, according to the U.S. Centers for Disease Control and Prevention, 625,000 abortions occurred nationally. Of those, 42.3% were medication abortions performed in the first 9 weeks, using a combination of the drugs mifepristone and misoprostol. Medication abortions now account for more than half of all pregnancy terminations in the United States, according to the Guttmacher Institute.

Dr. Harrison said that medication abortions put women at an elevated risk of serious, sometimes deadly bleeding, while ACOG points to evidence that the risk of childbirth to women is significantly higher. She also is no fan of Plan B, the “morning after” pill, which is available to women without having to consult a doctor. She described abortifacients as “a huge danger to women being harmed” by medications available over the counter.

In Dr. Harrison’s view, the 10-year-old Ohio girl who traveled to Indiana to obtain an abortion after she became pregnant as the result of rape should have continued her pregnancy. So, too, should young girls who are the victims of incest. “Incest is a horrific crime,” she said, “but aborting a girl because of incest doesn’t make her un-raped. It just adds another trauma.”

When told of Dr. Harrison’s comment, Ms. Meegan paused for 5 seconds before saying, “I think that statement speaks for itself.”

Louise Perkins King, MD, JD, an ob.gyn. and director of reproductive bioethics at Harvard Medical School, Boston, said she had the “horrific” experience of delivering a baby to an 11-year-old girl.

“Children are not fully developed, and they should not be having children,” Dr. King said.

Anne-Marie E. Amies Oelschlager, MD, vice chair of ACOG’s Clinical Consensus Committee and an ob.gyn. at Seattle Children’s in Washington, said in a statement that adolescents who are sexually assaulted are at extremely high risk of depression and posttraumatic stress disorder. “Do we expect a fourth-grader to carry a pregnancy to term, deliver, and expect that child to carry on after this horror?,” she asked.

Dr. Harrison dismissed such concerns. “Somehow abortion is a mental health treatment? Abortion doesn’t treat mental health problems,” she said. “Is there any proof that aborting in those circumstances improves their mental health? I would tell you there is very little research about it. …There are human beings involved, and this child who was raped, who also had a child, who was a human being, who is no longer.”  

Dr. Harrison said the Dobbs decision would have no effect on up to 93% of ob.gyns. who don’t perform abortions. Dr. King said the reason that most don’t perform the procedure is the “stigma” attached to abortion. “It’s still frowned upon,” she said. “We don’t talk about it as health care.”

Ms. Meegan added that ob.gyns. are fearful in the wake of the Dobbs decision because “they might find themselves subject to civil and criminal penalties.”

Dr. Harrison said that Roe was always a political decision and the science was always behind AAPLOG – something both Ms. Meegan and Dr. King dispute. Ms. Meegan and Dr. King said they are concerned about the chilling effects on both women and their clinicians, especially with laws that prevent referrals and travel to other states.

“You can’t compel me to give blood or bone marrow,” Dr. King said. “You can’t even compel me to give my hair for somebody, and you can’t compel me to give an organ. And all of a sudden when I’m pregnant, all my rights are out the window?”

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

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

Discontinuing antithyroid drugs during early pregnancy is linked to a possible rebound of hyperthyroidism and a high risk of adverse pregnancy outcomes, new research shows.

“Our study provides preliminary evidence that the risk of rebound increases in women with subnormal thyroid-stimulating hormone (TSH) and/or positive thyrotropin receptor antibody (TRAb) who stop antithyroid drugs in early pregnancy,” first author Xin Hou told this news organization.

“When discussing the pros and cons of antithyroid drug withdrawal early in pregnancy [clinicians] should consider the level of TSH and TRAb in early pregnancy,” said Hou, of the department of endocrinology and metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang.

Suvi Turunen, MD, of the University of Oulu (Finland), who has also conducted research on the issue, said the study adds important insights.

“I find this study very interesting,” Dr. Turunen said in an interview. “It is well known that medical treatment of hyperthyroidism outweighs the potential harms of antithyroid treatment.”

The new findings add to the evidence, she added. “I think that withdrawal of antithyroid drugs should be carefully considered, especially with autoantibody-positive patients,” Dr. Turunen said.
 

Hyperthyroidism a risk in pregnancy – with or without treatment

The potential risks of hyperthyroidism in pregnancy are well established and can range from preeclampsia to premature birth or miscarriage.

However, antithyroid drugs, including methimazole and propylthiouracil, carry their own risks. In crossing the placental barrier, the drugs can increase the risk of birth defects, particularly during 6-10 weeks of gestation, yet their discontinuation is linked to as much as a 50%-60% risk of relapse, the authors explain.

Because of the risks, the American Thyroid Association recommends that “women with a stable euthyroid state on 5-10 mg methimazole per day achieved within a few months, and a falling TRAb level, are likely candidates to withdraw from antithyroid drug therapy in early pregnancy,” the authors noted.

However, as the recommendations for women who are already pregnant are largely based on evidence from nonpregnant patients, Hou and colleagues sought to evaluate withdrawal among women who were pregnant.

For the study, published in Thyroid, they enrolled 63 women who were pregnant and part of an outpatient service of the department of endocrinology and metabolism at The First Affiliated Hospital of China Medical University, between September 2014 and March 2017, who had well-controlled hyperthyroidism in early pregnancy and discontinued the drugs.

The women were an average age of 27 years, and 28 were multigravida. Twenty-two had a history of miscarriage.

A follow-up of the patients until the end of their pregnancy showed that, overall, 20 (31.7%) had a rebound of hyperthyroidism during their pregnancy after withdrawing from the drugs.

Key factors associated with the highest risk of a rebound after discontinuation included having subnormal TSH levels (TSH < 0.35 mIU/L; odds ratio, 5.12; P  = .03) or having positive TRAb (TRAb > 1.75 IU/L; OR, 3.79; P = .02) at the time of medication withdrawal, compared with those with either normal TSH levels or negative TRAb.

The combination of both subnormal TSH and positive TRAb at the time of antithyroid medication withdrawal further boosted the risk of hyperthyroidism rebound (83.3%, 5 of 6), compared with those who had both normal TSH and negative TRAb (13%, 3 of 23; OR, 33.33; P = .003).

Adverse pregnancy outcomes increased

Importantly, among the 20 patients who had a rebound, 11 (55%) had adverse pregnancy outcomes, including miscarriage, premature birth, induced labor, gestational hypertension, and gestational diabetes, compared with only 4 (9.3%) of the 43 who had no rebound (OR, 11.92; P = .0002).

Neonatal abnormalities were also higher among those experiencing a rebound (20% vs. 4.7%), however, the authors noted that “larger prospective studies are required to conclude whether antithyroid drug withdrawal affects fetal outcome.”

In the rebound group, the mean duration of antithyroid medication use was 24.7 months versus 35.1 months in the nonrebound group, however, the difference was not statistically significant (P = .07). And 40% of the rebound group had a history of miscarriage versus 32.6% in the non-rebound group, but was also not significantly different (P = .56).

The authors noted that half of those in the rebound group developed hyperthyroidism more than 4 weeks after their withdrawal from antithyroid medications, “which seemed to have circumvented the most sensitive period of teratogenesis between 6 and 10 weeks of pregnancy.”

Hou added that restarting antithyroid medication did not increase the risk of adverse outcomes for offspring.

“A low dose of antithyroid medications may be a good choice for women with subnormal TSH and/or positive TRAb in early pregnancy,” Hou concluded. “Because of the small size of our study, a larger prospective study is needed to overcome the potential selection bias and to verify the conclusions.”
 

Findings consistent with Finnish study

In her own recent study, which included 2,144 women in Finland who experienced hyperthyroidism during pregnancy, Dr. Turunen and colleagues found that having hyperthyroidism, with or without antithyroid drug treatment, was associated with an increased odds of pregnancy and/or prenatal complications, compared with those without thyroid disease.

“In our study, we observed an increased risk of adverse pregnancy outcomes also in mothers with previous diagnosis and/or treatment of hyperthyroidism, not only with overt hyperthyroidism treated with antithyroid drugs,” she told this news organization.

“I think that especially those patients with positive antibodies [TRAbs] are at risk even if they are euthyroid,” she noted. “Withdrawal of antithyroid drugs in these patients is a risk.”

“Probably continuing antithyroid treatment with low dose is a better option,” she said.

The authors and Dr. Turunen reported no relevant financial relationships.

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

Discontinuing antithyroid drugs during early pregnancy is linked to a possible rebound of hyperthyroidism and a high risk of adverse pregnancy outcomes, new research shows.

“Our study provides preliminary evidence that the risk of rebound increases in women with subnormal thyroid-stimulating hormone (TSH) and/or positive thyrotropin receptor antibody (TRAb) who stop antithyroid drugs in early pregnancy,” first author Xin Hou told this news organization.

“When discussing the pros and cons of antithyroid drug withdrawal early in pregnancy [clinicians] should consider the level of TSH and TRAb in early pregnancy,” said Hou, of the department of endocrinology and metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang.

Suvi Turunen, MD, of the University of Oulu (Finland), who has also conducted research on the issue, said the study adds important insights.

“I find this study very interesting,” Dr. Turunen said in an interview. “It is well known that medical treatment of hyperthyroidism outweighs the potential harms of antithyroid treatment.”

The new findings add to the evidence, she added. “I think that withdrawal of antithyroid drugs should be carefully considered, especially with autoantibody-positive patients,” Dr. Turunen said.
 

Hyperthyroidism a risk in pregnancy – with or without treatment

The potential risks of hyperthyroidism in pregnancy are well established and can range from preeclampsia to premature birth or miscarriage.

However, antithyroid drugs, including methimazole and propylthiouracil, carry their own risks. In crossing the placental barrier, the drugs can increase the risk of birth defects, particularly during 6-10 weeks of gestation, yet their discontinuation is linked to as much as a 50%-60% risk of relapse, the authors explain.

Because of the risks, the American Thyroid Association recommends that “women with a stable euthyroid state on 5-10 mg methimazole per day achieved within a few months, and a falling TRAb level, are likely candidates to withdraw from antithyroid drug therapy in early pregnancy,” the authors noted.

However, as the recommendations for women who are already pregnant are largely based on evidence from nonpregnant patients, Hou and colleagues sought to evaluate withdrawal among women who were pregnant.

For the study, published in Thyroid, they enrolled 63 women who were pregnant and part of an outpatient service of the department of endocrinology and metabolism at The First Affiliated Hospital of China Medical University, between September 2014 and March 2017, who had well-controlled hyperthyroidism in early pregnancy and discontinued the drugs.

The women were an average age of 27 years, and 28 were multigravida. Twenty-two had a history of miscarriage.

A follow-up of the patients until the end of their pregnancy showed that, overall, 20 (31.7%) had a rebound of hyperthyroidism during their pregnancy after withdrawing from the drugs.

Key factors associated with the highest risk of a rebound after discontinuation included having subnormal TSH levels (TSH < 0.35 mIU/L; odds ratio, 5.12; P  = .03) or having positive TRAb (TRAb > 1.75 IU/L; OR, 3.79; P = .02) at the time of medication withdrawal, compared with those with either normal TSH levels or negative TRAb.

The combination of both subnormal TSH and positive TRAb at the time of antithyroid medication withdrawal further boosted the risk of hyperthyroidism rebound (83.3%, 5 of 6), compared with those who had both normal TSH and negative TRAb (13%, 3 of 23; OR, 33.33; P = .003).

Adverse pregnancy outcomes increased

Importantly, among the 20 patients who had a rebound, 11 (55%) had adverse pregnancy outcomes, including miscarriage, premature birth, induced labor, gestational hypertension, and gestational diabetes, compared with only 4 (9.3%) of the 43 who had no rebound (OR, 11.92; P = .0002).

Neonatal abnormalities were also higher among those experiencing a rebound (20% vs. 4.7%), however, the authors noted that “larger prospective studies are required to conclude whether antithyroid drug withdrawal affects fetal outcome.”

In the rebound group, the mean duration of antithyroid medication use was 24.7 months versus 35.1 months in the nonrebound group, however, the difference was not statistically significant (P = .07). And 40% of the rebound group had a history of miscarriage versus 32.6% in the non-rebound group, but was also not significantly different (P = .56).

The authors noted that half of those in the rebound group developed hyperthyroidism more than 4 weeks after their withdrawal from antithyroid medications, “which seemed to have circumvented the most sensitive period of teratogenesis between 6 and 10 weeks of pregnancy.”

Hou added that restarting antithyroid medication did not increase the risk of adverse outcomes for offspring.

“A low dose of antithyroid medications may be a good choice for women with subnormal TSH and/or positive TRAb in early pregnancy,” Hou concluded. “Because of the small size of our study, a larger prospective study is needed to overcome the potential selection bias and to verify the conclusions.”
 

Findings consistent with Finnish study

In her own recent study, which included 2,144 women in Finland who experienced hyperthyroidism during pregnancy, Dr. Turunen and colleagues found that having hyperthyroidism, with or without antithyroid drug treatment, was associated with an increased odds of pregnancy and/or prenatal complications, compared with those without thyroid disease.

“In our study, we observed an increased risk of adverse pregnancy outcomes also in mothers with previous diagnosis and/or treatment of hyperthyroidism, not only with overt hyperthyroidism treated with antithyroid drugs,” she told this news organization.

“I think that especially those patients with positive antibodies [TRAbs] are at risk even if they are euthyroid,” she noted. “Withdrawal of antithyroid drugs in these patients is a risk.”

“Probably continuing antithyroid treatment with low dose is a better option,” she said.

The authors and Dr. Turunen reported no relevant financial relationships.

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

Discontinuing antithyroid drugs during early pregnancy is linked to a possible rebound of hyperthyroidism and a high risk of adverse pregnancy outcomes, new research shows.

“Our study provides preliminary evidence that the risk of rebound increases in women with subnormal thyroid-stimulating hormone (TSH) and/or positive thyrotropin receptor antibody (TRAb) who stop antithyroid drugs in early pregnancy,” first author Xin Hou told this news organization.

“When discussing the pros and cons of antithyroid drug withdrawal early in pregnancy [clinicians] should consider the level of TSH and TRAb in early pregnancy,” said Hou, of the department of endocrinology and metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang.

Suvi Turunen, MD, of the University of Oulu (Finland), who has also conducted research on the issue, said the study adds important insights.

“I find this study very interesting,” Dr. Turunen said in an interview. “It is well known that medical treatment of hyperthyroidism outweighs the potential harms of antithyroid treatment.”

The new findings add to the evidence, she added. “I think that withdrawal of antithyroid drugs should be carefully considered, especially with autoantibody-positive patients,” Dr. Turunen said.
 

Hyperthyroidism a risk in pregnancy – with or without treatment

The potential risks of hyperthyroidism in pregnancy are well established and can range from preeclampsia to premature birth or miscarriage.

However, antithyroid drugs, including methimazole and propylthiouracil, carry their own risks. In crossing the placental barrier, the drugs can increase the risk of birth defects, particularly during 6-10 weeks of gestation, yet their discontinuation is linked to as much as a 50%-60% risk of relapse, the authors explain.

Because of the risks, the American Thyroid Association recommends that “women with a stable euthyroid state on 5-10 mg methimazole per day achieved within a few months, and a falling TRAb level, are likely candidates to withdraw from antithyroid drug therapy in early pregnancy,” the authors noted.

However, as the recommendations for women who are already pregnant are largely based on evidence from nonpregnant patients, Hou and colleagues sought to evaluate withdrawal among women who were pregnant.

For the study, published in Thyroid, they enrolled 63 women who were pregnant and part of an outpatient service of the department of endocrinology and metabolism at The First Affiliated Hospital of China Medical University, between September 2014 and March 2017, who had well-controlled hyperthyroidism in early pregnancy and discontinued the drugs.

The women were an average age of 27 years, and 28 were multigravida. Twenty-two had a history of miscarriage.

A follow-up of the patients until the end of their pregnancy showed that, overall, 20 (31.7%) had a rebound of hyperthyroidism during their pregnancy after withdrawing from the drugs.

Key factors associated with the highest risk of a rebound after discontinuation included having subnormal TSH levels (TSH < 0.35 mIU/L; odds ratio, 5.12; P  = .03) or having positive TRAb (TRAb > 1.75 IU/L; OR, 3.79; P = .02) at the time of medication withdrawal, compared with those with either normal TSH levels or negative TRAb.

The combination of both subnormal TSH and positive TRAb at the time of antithyroid medication withdrawal further boosted the risk of hyperthyroidism rebound (83.3%, 5 of 6), compared with those who had both normal TSH and negative TRAb (13%, 3 of 23; OR, 33.33; P = .003).

Adverse pregnancy outcomes increased

Importantly, among the 20 patients who had a rebound, 11 (55%) had adverse pregnancy outcomes, including miscarriage, premature birth, induced labor, gestational hypertension, and gestational diabetes, compared with only 4 (9.3%) of the 43 who had no rebound (OR, 11.92; P = .0002).

Neonatal abnormalities were also higher among those experiencing a rebound (20% vs. 4.7%), however, the authors noted that “larger prospective studies are required to conclude whether antithyroid drug withdrawal affects fetal outcome.”

In the rebound group, the mean duration of antithyroid medication use was 24.7 months versus 35.1 months in the nonrebound group, however, the difference was not statistically significant (P = .07). And 40% of the rebound group had a history of miscarriage versus 32.6% in the non-rebound group, but was also not significantly different (P = .56).

The authors noted that half of those in the rebound group developed hyperthyroidism more than 4 weeks after their withdrawal from antithyroid medications, “which seemed to have circumvented the most sensitive period of teratogenesis between 6 and 10 weeks of pregnancy.”

Hou added that restarting antithyroid medication did not increase the risk of adverse outcomes for offspring.

“A low dose of antithyroid medications may be a good choice for women with subnormal TSH and/or positive TRAb in early pregnancy,” Hou concluded. “Because of the small size of our study, a larger prospective study is needed to overcome the potential selection bias and to verify the conclusions.”
 

Findings consistent with Finnish study

In her own recent study, which included 2,144 women in Finland who experienced hyperthyroidism during pregnancy, Dr. Turunen and colleagues found that having hyperthyroidism, with or without antithyroid drug treatment, was associated with an increased odds of pregnancy and/or prenatal complications, compared with those without thyroid disease.

“In our study, we observed an increased risk of adverse pregnancy outcomes also in mothers with previous diagnosis and/or treatment of hyperthyroidism, not only with overt hyperthyroidism treated with antithyroid drugs,” she told this news organization.

“I think that especially those patients with positive antibodies [TRAbs] are at risk even if they are euthyroid,” she noted. “Withdrawal of antithyroid drugs in these patients is a risk.”

“Probably continuing antithyroid treatment with low dose is a better option,” she said.

The authors and Dr. Turunen reported no relevant financial relationships.

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

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.

The use of laparoscopic power morcellators for minimally invasive hysterectomy has significantly decreased, and while the use of containment bags increased after the U.S. Food and Drug Administration’s 2014 safety warning about power morcellators, most procedures employing them are still performed without bags, according to a large database study in Obstetrics & Gynecology.

Containment bags are thought to limit the dissemination of potentially pathologic tissue, including unsuspected cancerous cells.

Rates of uterine cancer in women having morcellation were similar before and after the 2014 FDA guidance, and containment bags were used in only a small proportion of women with uterine cancer, according to findings from a research group led by Jason D. Wright, MD, of the division of gynecologic oncology at Columbia University, New York.

“Despite warnings from professional societies and regulatory agencies, as well as intense public scrutiny after the FDA warnings, the majority of morcellated uterine cancers occurred with uncontained laparoscopic power morcellation,” Dr. Wright and associates wrote, adding that the findings have important policy implications. First, efforts are needed to ensure morcellation is avoided in women with pathologic abnormalities. Second, despite regulatory approval, the safety and efficacy of containment bags remain uncertain, and the use and outcomes of these devices should be monitored closely.

The authors noted that laparoscopic power morcellation with a containment bag actually carries a small but significant increase in the risk of complications, compared with uncontained morcellation.

The study

Drawing on the Premier Healthcare Database, the researchers looked at deidentified patients aged 18 years or older who underwent laparoscopic supracervical hysterectomy from 2010 to 2018. The largest age group having the procedure consisted of women aged 40-49.

Patients were stratified based on use of laparoscopic power morcellators.

The cohort was further stratified as either pre–FDA guidance (2010 quarter 1 to 2014 quarter 1) or post–FDA guidance (2014 quarter 2 to 2018 quarter 2).

In the final cohort of 67,115 patients, laparoscopic power morcellator use decreased from 66.7% in 2013 quarter 4 to 13.3% by 2018 quarter 2. The likelihood of using this device decreased by 9.5% for each quarter elapsed in the post–FDA warning period (risk ratio, 0.91; 95% confidence interval, 0.90-0.91).

In other findings, containment bag use rose from 5.2% in 2013 quarter 4 to 15.2% by 2018 quarter 2. The likelihood of containment bag use rose by 3% for each quarter elapsed in the post–FDA warning period (RR, 1.03; 95% CI, 1.02-1.05).

Among women who underwent surgery with laparoscopic power morcellator use, uterine cancers or sarcomas were identified in 54 (0.17%) before the FDA guidance, compared with 7 (0.12%) after the guidance (P = .45).

Containment bags were used in 11.1% of women with uterine cancers or sarcomas before the FDA guidance, compared with 14.3% after the guidance (P = .12). The perioperative complication rate was 3.3% among women who had laparoscopic power morcellator use without a containment bag, compared with 4.5% (P = .001) in those with a containment bag (adjusted RR, 1.35; 95% CI, 1.12-1.64).

A related editorial argued that the backlash against power morcellation was unwarranted and an example of “reactionary medicine.”

Ben A. Abdu, MD, and Cameron Lowry, MD, of the department of obstetrics and gynecology at the University of Tennessee Health Science Center in Memphis, noted that with the known advantages of laparoscopy over laparotomy – decreased blood loss, decreased pain, and fewer wound complications and infections – it is of paramount importance to continue to offer minimally invasive surgery whenever possible. After the FDA raised safety concerns, there was a rise in the rate of open abdominal hysterectomy, which was accompanied by an increase in surgical morbidity. “Perhaps for now we should avoid throwing the baby out with the bath water,” they wrote.

The editorialists pointed out that any surgery may entail unintended complications. “It is also important to remember that there is a risk of dissemination of malignant tissue whether or not power morcellation is used, and it has even been observed in laparotomy,” they stated, noting that bag rupture and tissue spillage can occur even when the containment bag remains intact.

The downward trend in the use of power morcellators observed by Dr. Wright’s group is of serious concern, the commentators added, especially because the FDA communication was made in response to a rare occurrence and possibly resting on an overestimation of risk. “Based on their review of the medical literature at the time, the FDA cited prevalence estimates of 1 in 352 for any uterine sarcoma and 1 in 498 for leiomyosarcoma,” they wrote. “Many authors have expressed concern that the FDA data review was overestimated.” For example, they cite a meta-analysis using prospective data in which the prevalence of occult leiomyosarcoma was estimated at 1 in 8,300. Despite this extremely low prevalence, there has been an almost total nationwide hospital moratorium on the use of power morcellation, which will likely continue. Some manufacturers have ceased or limited production, distribution, and sales of these devices, they noted.

According to Dr. Michael L. Nimaroff, MD, however, chief of minimally invasive gynecologic surgery at Northwell Health in New Hyde Park, N.Y., the general post–FDA-guidance backlash did not have much effect on expert practitioners in this surgical field. “Those of us who specialize in minimally invasive gynecologic surgery, which has many benefits for the patients, never pivoted,” he told this news organization. “We continued to perform it but more conscientiously and with more concern for safety.”

As for morcellator use, added Dr. Nimaroff, specialists were so accustomed to doing these surgeries before the containment systems were made available that they don’t miss the power morcellator. “We actually retrieve tissue manually, and most of our morcellations, if they’re not contained manually, are retrieved vaginally or through a slightly bigger incision. So patients still benefit from minimally invasive surgery, and in some cases these techniques actually shorten the operation.”

This study received no external funding. Dr. Wright is editor in chief of Obstetrics & Gynecology. He reported royalties from UpToDate and has received research support from Merck. Coauthor Dr. Hou has served as a consultant for Foundation Medicine and Natera. Dr. Abdu and Dr. Lowry disclosed no competing interests, as did Dr. Nimaroff.

The use of laparoscopic power morcellators for minimally invasive hysterectomy has significantly decreased, and while the use of containment bags increased after the U.S. Food and Drug Administration’s 2014 safety warning about power morcellators, most procedures employing them are still performed without bags, according to a large database study in Obstetrics & Gynecology.

Containment bags are thought to limit the dissemination of potentially pathologic tissue, including unsuspected cancerous cells.

Rates of uterine cancer in women having morcellation were similar before and after the 2014 FDA guidance, and containment bags were used in only a small proportion of women with uterine cancer, according to findings from a research group led by Jason D. Wright, MD, of the division of gynecologic oncology at Columbia University, New York.

“Despite warnings from professional societies and regulatory agencies, as well as intense public scrutiny after the FDA warnings, the majority of morcellated uterine cancers occurred with uncontained laparoscopic power morcellation,” Dr. Wright and associates wrote, adding that the findings have important policy implications. First, efforts are needed to ensure morcellation is avoided in women with pathologic abnormalities. Second, despite regulatory approval, the safety and efficacy of containment bags remain uncertain, and the use and outcomes of these devices should be monitored closely.

The authors noted that laparoscopic power morcellation with a containment bag actually carries a small but significant increase in the risk of complications, compared with uncontained morcellation.

The study

Drawing on the Premier Healthcare Database, the researchers looked at deidentified patients aged 18 years or older who underwent laparoscopic supracervical hysterectomy from 2010 to 2018. The largest age group having the procedure consisted of women aged 40-49.

Patients were stratified based on use of laparoscopic power morcellators.

The cohort was further stratified as either pre–FDA guidance (2010 quarter 1 to 2014 quarter 1) or post–FDA guidance (2014 quarter 2 to 2018 quarter 2).

In the final cohort of 67,115 patients, laparoscopic power morcellator use decreased from 66.7% in 2013 quarter 4 to 13.3% by 2018 quarter 2. The likelihood of using this device decreased by 9.5% for each quarter elapsed in the post–FDA warning period (risk ratio, 0.91; 95% confidence interval, 0.90-0.91).

In other findings, containment bag use rose from 5.2% in 2013 quarter 4 to 15.2% by 2018 quarter 2. The likelihood of containment bag use rose by 3% for each quarter elapsed in the post–FDA warning period (RR, 1.03; 95% CI, 1.02-1.05).

Among women who underwent surgery with laparoscopic power morcellator use, uterine cancers or sarcomas were identified in 54 (0.17%) before the FDA guidance, compared with 7 (0.12%) after the guidance (P = .45).

Containment bags were used in 11.1% of women with uterine cancers or sarcomas before the FDA guidance, compared with 14.3% after the guidance (P = .12). The perioperative complication rate was 3.3% among women who had laparoscopic power morcellator use without a containment bag, compared with 4.5% (P = .001) in those with a containment bag (adjusted RR, 1.35; 95% CI, 1.12-1.64).

A related editorial argued that the backlash against power morcellation was unwarranted and an example of “reactionary medicine.”

Ben A. Abdu, MD, and Cameron Lowry, MD, of the department of obstetrics and gynecology at the University of Tennessee Health Science Center in Memphis, noted that with the known advantages of laparoscopy over laparotomy – decreased blood loss, decreased pain, and fewer wound complications and infections – it is of paramount importance to continue to offer minimally invasive surgery whenever possible. After the FDA raised safety concerns, there was a rise in the rate of open abdominal hysterectomy, which was accompanied by an increase in surgical morbidity. “Perhaps for now we should avoid throwing the baby out with the bath water,” they wrote.

The editorialists pointed out that any surgery may entail unintended complications. “It is also important to remember that there is a risk of dissemination of malignant tissue whether or not power morcellation is used, and it has even been observed in laparotomy,” they stated, noting that bag rupture and tissue spillage can occur even when the containment bag remains intact.

The downward trend in the use of power morcellators observed by Dr. Wright’s group is of serious concern, the commentators added, especially because the FDA communication was made in response to a rare occurrence and possibly resting on an overestimation of risk. “Based on their review of the medical literature at the time, the FDA cited prevalence estimates of 1 in 352 for any uterine sarcoma and 1 in 498 for leiomyosarcoma,” they wrote. “Many authors have expressed concern that the FDA data review was overestimated.” For example, they cite a meta-analysis using prospective data in which the prevalence of occult leiomyosarcoma was estimated at 1 in 8,300. Despite this extremely low prevalence, there has been an almost total nationwide hospital moratorium on the use of power morcellation, which will likely continue. Some manufacturers have ceased or limited production, distribution, and sales of these devices, they noted.

According to Dr. Michael L. Nimaroff, MD, however, chief of minimally invasive gynecologic surgery at Northwell Health in New Hyde Park, N.Y., the general post–FDA-guidance backlash did not have much effect on expert practitioners in this surgical field. “Those of us who specialize in minimally invasive gynecologic surgery, which has many benefits for the patients, never pivoted,” he told this news organization. “We continued to perform it but more conscientiously and with more concern for safety.”

As for morcellator use, added Dr. Nimaroff, specialists were so accustomed to doing these surgeries before the containment systems were made available that they don’t miss the power morcellator. “We actually retrieve tissue manually, and most of our morcellations, if they’re not contained manually, are retrieved vaginally or through a slightly bigger incision. So patients still benefit from minimally invasive surgery, and in some cases these techniques actually shorten the operation.”

This study received no external funding. Dr. Wright is editor in chief of Obstetrics & Gynecology. He reported royalties from UpToDate and has received research support from Merck. Coauthor Dr. Hou has served as a consultant for Foundation Medicine and Natera. Dr. Abdu and Dr. Lowry disclosed no competing interests, as did Dr. Nimaroff.

The use of laparoscopic power morcellators for minimally invasive hysterectomy has significantly decreased, and while the use of containment bags increased after the U.S. Food and Drug Administration’s 2014 safety warning about power morcellators, most procedures employing them are still performed without bags, according to a large database study in Obstetrics & Gynecology.

Containment bags are thought to limit the dissemination of potentially pathologic tissue, including unsuspected cancerous cells.

Rates of uterine cancer in women having morcellation were similar before and after the 2014 FDA guidance, and containment bags were used in only a small proportion of women with uterine cancer, according to findings from a research group led by Jason D. Wright, MD, of the division of gynecologic oncology at Columbia University, New York.

“Despite warnings from professional societies and regulatory agencies, as well as intense public scrutiny after the FDA warnings, the majority of morcellated uterine cancers occurred with uncontained laparoscopic power morcellation,” Dr. Wright and associates wrote, adding that the findings have important policy implications. First, efforts are needed to ensure morcellation is avoided in women with pathologic abnormalities. Second, despite regulatory approval, the safety and efficacy of containment bags remain uncertain, and the use and outcomes of these devices should be monitored closely.

The authors noted that laparoscopic power morcellation with a containment bag actually carries a small but significant increase in the risk of complications, compared with uncontained morcellation.

The study

Drawing on the Premier Healthcare Database, the researchers looked at deidentified patients aged 18 years or older who underwent laparoscopic supracervical hysterectomy from 2010 to 2018. The largest age group having the procedure consisted of women aged 40-49.

Patients were stratified based on use of laparoscopic power morcellators.

The cohort was further stratified as either pre–FDA guidance (2010 quarter 1 to 2014 quarter 1) or post–FDA guidance (2014 quarter 2 to 2018 quarter 2).

In the final cohort of 67,115 patients, laparoscopic power morcellator use decreased from 66.7% in 2013 quarter 4 to 13.3% by 2018 quarter 2. The likelihood of using this device decreased by 9.5% for each quarter elapsed in the post–FDA warning period (risk ratio, 0.91; 95% confidence interval, 0.90-0.91).

In other findings, containment bag use rose from 5.2% in 2013 quarter 4 to 15.2% by 2018 quarter 2. The likelihood of containment bag use rose by 3% for each quarter elapsed in the post–FDA warning period (RR, 1.03; 95% CI, 1.02-1.05).

Among women who underwent surgery with laparoscopic power morcellator use, uterine cancers or sarcomas were identified in 54 (0.17%) before the FDA guidance, compared with 7 (0.12%) after the guidance (P = .45).

Containment bags were used in 11.1% of women with uterine cancers or sarcomas before the FDA guidance, compared with 14.3% after the guidance (P = .12). The perioperative complication rate was 3.3% among women who had laparoscopic power morcellator use without a containment bag, compared with 4.5% (P = .001) in those with a containment bag (adjusted RR, 1.35; 95% CI, 1.12-1.64).

A related editorial argued that the backlash against power morcellation was unwarranted and an example of “reactionary medicine.”

Ben A. Abdu, MD, and Cameron Lowry, MD, of the department of obstetrics and gynecology at the University of Tennessee Health Science Center in Memphis, noted that with the known advantages of laparoscopy over laparotomy – decreased blood loss, decreased pain, and fewer wound complications and infections – it is of paramount importance to continue to offer minimally invasive surgery whenever possible. After the FDA raised safety concerns, there was a rise in the rate of open abdominal hysterectomy, which was accompanied by an increase in surgical morbidity. “Perhaps for now we should avoid throwing the baby out with the bath water,” they wrote.

The editorialists pointed out that any surgery may entail unintended complications. “It is also important to remember that there is a risk of dissemination of malignant tissue whether or not power morcellation is used, and it has even been observed in laparotomy,” they stated, noting that bag rupture and tissue spillage can occur even when the containment bag remains intact.

The downward trend in the use of power morcellators observed by Dr. Wright’s group is of serious concern, the commentators added, especially because the FDA communication was made in response to a rare occurrence and possibly resting on an overestimation of risk. “Based on their review of the medical literature at the time, the FDA cited prevalence estimates of 1 in 352 for any uterine sarcoma and 1 in 498 for leiomyosarcoma,” they wrote. “Many authors have expressed concern that the FDA data review was overestimated.” For example, they cite a meta-analysis using prospective data in which the prevalence of occult leiomyosarcoma was estimated at 1 in 8,300. Despite this extremely low prevalence, there has been an almost total nationwide hospital moratorium on the use of power morcellation, which will likely continue. Some manufacturers have ceased or limited production, distribution, and sales of these devices, they noted.

According to Dr. Michael L. Nimaroff, MD, however, chief of minimally invasive gynecologic surgery at Northwell Health in New Hyde Park, N.Y., the general post–FDA-guidance backlash did not have much effect on expert practitioners in this surgical field. “Those of us who specialize in minimally invasive gynecologic surgery, which has many benefits for the patients, never pivoted,” he told this news organization. “We continued to perform it but more conscientiously and with more concern for safety.”

As for morcellator use, added Dr. Nimaroff, specialists were so accustomed to doing these surgeries before the containment systems were made available that they don’t miss the power morcellator. “We actually retrieve tissue manually, and most of our morcellations, if they’re not contained manually, are retrieved vaginally or through a slightly bigger incision. So patients still benefit from minimally invasive surgery, and in some cases these techniques actually shorten the operation.”

This study received no external funding. Dr. Wright is editor in chief of Obstetrics & Gynecology. He reported royalties from UpToDate and has received research support from Merck. Coauthor Dr. Hou has served as a consultant for Foundation Medicine and Natera. Dr. Abdu and Dr. Lowry disclosed no competing interests, as did Dr. Nimaroff.

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

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

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

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

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

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

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.