Women's Health

WASHINGTON — Continuous glucose monitoring (CGM) is widely used during pregnancy for individuals with type 1 diabetes — with pregnancy-specific target metrics now chosen and benefits on perinatal outcomes demonstrated — but more research is needed to elucidate its role in the growing population of pregnant people with type 2 diabetes and gestational diabetes (GDM). And overall, there are still “many more questions unanswered about CGM use in pregnancy than what we have answered,” Celeste Durnwald, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

There’s much to learn about how to best interpret “the detailed and complex data that CGM provides,” and what targets in addition to time in range (TIR) are most important, said Dr. Durnwald, director of the perinatal diabetes program and associate professor of ob.gyn. at the Hospital of the University of Pennsylvania, Philadelphia, in a presentation on CGM.

Among other questions are whether fasting glucose is “as important in the era of CGM,” and whether there should be different glycemic targets for nocturnal versus daytime TIR, she said. Moreover, questions justifiably remain about whether the TIR targets for type 1 diabetes in pregnancy are indeed optimal, she said in a discussion period.

Ongoing research is looking at whether CGM can motivate and guide patients with GDM through diet and lifestyle changes such that “we can see changes in amounts of medication we use,” Dr. Durnwald noted in her presentation. “There’s a whole breadth of research looking at whether CGM can help predict diagnosis of GDM, large for gestational age, or preeclampsia, and what are the targets.”

Maternal hypoglycemia during pregnancy — a time when strict glycemic control is recommended to reduce the risk of congenital malformations and other fetal and neonatal morbidity — remains a concern in type 1 diabetes, even with widespread use of CGM in this population, said Barak Rosenn, MD, during a presentation on glycemic control in type 1 diabetes.

A pilot study of a newly designed pregnancy-specific closed-loop insulin delivery system, published last year (Diabetes Care. 2023;46:1425-31), has offered the first “really encouraging information about the ability to use our most up-to-date technology to help our type 1 patients maintain strict control and at the same time decrease their risk of severe hypoglycemia,” said Dr. Rosenn, a maternal-fetal medicine specialist at the Jersey City Medical Center, Jersey City, New Jersey.

Guidance for tight intrapartum glucose control, meanwhile, has been backed by little evidence, said Michal Fishel Bartal, MD, MS, and some recent studies and reviews have shown little to no effect of such tight control on neonatal hypoglycemia, which is the aim of the guidance.

“We need to reexamine current recommendations,” said Dr. Bartal, assistant professor in the division of maternal-fetal medicine at the University of Texas Health Science Center, Houston, during a presentation on intrapartum care. “There’s very limited evidence-based data for the way we manage people with diabetes [during labor and delivery].”

The Knowns And Unknowns of CGM in Pregnancy

The multicenter, international CONCEPTT trial (Continuous Glucose Monitoring in Pregnant Women With Type 1 Diabetes), published in 2017, was the first trial to demonstrate improvements in perinatal outcomes, and it “brought CGM to the forefront in terms of widespread use,” Dr. Durnwald said.

The trial randomized more than 300 patients with type 1 diabetes who were pregnant or planning pregnancy (both users of insulin pumps and users of multiple insulin injections) to continuous, real-time CGM in addition to finger-stick glucose monitoring, or standard finger-stick glucose tests alone. In addition to small improvements in A1c and 7% more TIR (without an increase in hypoglycemia), pregnant CGM users had reductions in large-for-gestational age (LGA) births (53% vs 69%, P = .0489), neonatal intensive care admissions lasting more than 24 hours, and severe neonatal hypoglycemia.

Numbers needed to treat to prevent adverse outcomes in the CONCEPTT trial were six for LGA, six for NICU admission, and eight for neonatal hypoglycemia.

Data from the CONCEPTT trial featured prominently in the development of consensus recommendations for CGM targets in pregnancy by an international expert panel endorsed by the American Diabetes Association. In its 2019 report, the group recommended a target range of 63-140 mg/dL for type 1 and type 2 diabetes during pregnancy (compared with 70-180 mg/dL outside of pregnancy), and a TIR > 70% for pregnant people with type 1 diabetes. (Targets for time below range and time above range are also defined for type 1.)

More data are needed, the group said, in order to recommend TIR targets for type 2 diabetes in pregnancy or GDM (Diabetes Care. 2019;42:1593-603). “Many argue,” Dr. Durnwald said, “that there could be more stringent targets for those at less risk for [maternal] hypoglycemia, especially our GDM population.”

There’s a question of whether even higher TIR would further improve perinatal outcomes, she said, “or will we reach a threshold where higher TIR doesn’t get us a [further] reduction in LGA or preeclampsia.”

And while TIR is “certainly our buzzword,” lower mean glucose levels have also been associated with a lower risk of LGA and other adverse neonatal outcomes. A 2019 retrospective study from Sweden, for instance, analyzed patterns of CGM data from 186 pregnant women with type 1 diabetes and found significant associations between elevated mean glucose levels (in the second and third trimesters) and both LGA and an adverse neonatal composite outcome (Diabetologia. 2019;62:1143-53).

Elevated TIR was also associated with LGA, but “mean glucose had the strongest association with the rate of LGA,” Dr. Durnwald said.

Similarly, a 2020 subanalysis of the CONCEPTT trial data found that a higher mean glucose at both 24 and 34 weeks of gestation was significantly associated with a greater risk of LGA (Diabetes Care. 2020;43:1178-84), and a smaller 2015 analysis of data from two randomized controlled trials of CGM in pregnant women with type 1 and type 2 diabetes found this association in trimesters 2 and 3 (Diabetes Care. 2015;38;1319-25).

The ADA’s Standards of Care in Diabetes (Diabetes Care. 2024;47:S282-S294) endorse CGM as an adjunctive tool in pregnancy — not as a replacement for all traditional blood glucose monitoring — and advise that the use of CGM-reported mean glucose is superior to the use of estimated A1c, glucose management indicator, and other calculations to estimate A1c. Changes occur in pregnancy, Dr. Durnwald pointed out. “Most experts will identify a [target] mean glucose < 120 mg/dL in those with type 1, but there’s potential to have a mean glucose closer to 100 in certainly our patients with GDM and some of our patients with type 2,” she said. To a lesser extent, researchers have also looked at the effect of CMG-reported glycemic variability on outcomes such as LGA, with at least two studies finding some association, and there has been some research on nocturnal glucose and LGA, Dr. Durnwald said. CGM “gives us the opportunity,” she said, “to think about nocturnal glucose as a possible target” for further optimizing diabetes management during pregnancy.

CGM in Type 2, GDM

CGM in type 2 diabetes in pregnancy was addressed in a recently published systematic review and meta-analysis, which found only three qualifying randomized controlled trials and concluded that CGM use was not associated with improvements in perinatal outcomes, as assessed by LGA and preeclampsia (Am J Obstet Gynecol MFM. 2023;5:100969). “It’s very limited by the small sample size and the fact that most [patients] were using intermittent CGM,” Dr. Durnwald said. “It highlights how important it is to perform larger studies with continuous CGM.”

While the 2024 ADA standards say there are insufficient data to support the use of CGM in all patients with type 2 diabetes or GDM — and that the decision should be individualized “based on treatment regimen, circumstance, preferences, and needs” — real-world access to CGM for type 2, and even a bit for GDM, is improving, she said.

Some insurers require patients to be on insulin, but the trends are such that “we certainly talk about CGM to all our patients with type 2 diabetes and even our patients with GDM,” Dr. Durnwald said in a later interview. “CGMs are being advertised so we definitely have people who ask about them upon diagnosis, and we try to make it work for them.”
 

Is Preventing Maternal Hypoglycemia Possible?

Advancements in technology and pharmacology aimed at optimizing glycemic control — increased adoption of CGM, the use of insulin pump therapy, and the use of more rapid insulin analogs — appear to have had little to no impact on rates of severe maternal hypoglycemia in type 1 diabetes in pregnancy, said Dr. Rosenn, referring to several published studies.

The CONCEPTT study in type 1 diabetes, for instance, “gave us the best data we have on the use of CGM,” but differences in the percentage of patients with severe hypoglycemia and the total number of severe hypoglycemia episodes were basically the same whether patients used CGM or not, he said.

Closed-loop insulin delivery systems have been found in nonpregnant patients with type 1 diabetes to “be helpful in keeping people in range and also possibly [decreasing nocturnal hypoglycemia],” but the systems are not approved for use in pregnancy. “There’s not enough data on use in pregnancy, but probably more important, the algorithms used in the closed-loop systems are not directed to the targets we consider ideal for pregnancy,” Dr. Rosenn said.

In a pilot study of a closed-loop delivery system customized for pregnancies complicated by type 1 diabetes, 10 pregnant women were recruited at 14-32 weeks and, after a 1- to 2-week run-in period using a regular CGM-augmented pump, they used the closed-loop system targeting a daytime glucose of 80-110 mg/dL and nocturnal glucose of 80-100 mg/dL.

Mean TIR (a target range of 63-140 mg/dL) increased from 65% during the run-in period to 79% on the closed-loop system, and there were significant decreases in both time above range and time in the hypoglycemic ranges of < 63 mg/dL and < 54 mg/dL. Hypoglycemic events per week (defined as < 54 mg/dL for over 15 minutes) decreased from 4 to 0.7 (Diabetes Care. 2023;46:1425-31).

The investigators are continuing their research, and there are currently two randomized controlled trials underway examining use of closed-loop systems designed for pregnancy, said Dr. Rosenn, who was involved in feasibility research leading up to the pilot study. “So I’m hopeful we’ll see some encouraging information in the future.”

Maternal hypoglycemia during pregnancy is more common in type 1 diabetes, but it also affects pregnancies complicated by type 2 diabetes and GDM. In addition to the strict glycemic control imposed to improve maternal and fetal outcomes, pregnancy itself plays a role.

Research several decades ago from the Diabetes in Pregnancy Program Project, a prospective cohort in Cincinnati which Dr. Rosenn co-led, documented impaired counterregulatory physiology in pregnancy. Even in nondiabetic patients, there are declines in secretion of glucagon and growth hormone in response to hypoglycemia, for instance. In patients with type 1 diabetes, the diminishment in counterregulatory response is more severe.

Rethinking Intrapartum Care

Guidance for tight blood glucose control during labor and delivery for insulin-treated individuals — as reflected in the American College of Obstetricians and Gynecologists Practice Bulletin No. 201 on Pregestational Diabetes and in recommendations from the United Kingdom’s National Institute for Health and Care Excellence (NICE) — is based on small case series and overall “poor-quality” evidence that more recent research has failed to back up, Dr. Bartal said.

A systematic review published in 2018, for example, concluded there is a paucity of high-quality data supporting the association of glucose during labor and delivery with neonatal hypoglycemia in pregnancies complicated by diabetes (Diabet Med. 2018;35:173-83). And in a subsequent retrospective cohort study of pregnant women with type 1/type 2/GDM and their neonates, the same investigators reported no difference in the target glucose in labor between those with and without neonatal hypotension, after adjustment for important neonatal factors such as LGA and preterm delivery (Diabet Med. 2020;37:138-46).

Also exemplifying the body of research, Dr. Bartal said, is another single-center retrospective study published in 2020 that evaluated outcomes in the years before and after the institution of a formal intrapartum insulin regimen (a standardized protocol for titration of insulin and glucose infusions) for women with pregestational or gestational diabetes. The protocol was associated with improved maternal glucose control, but an increased frequency of neonatal hypoglycemia (Obstet Gynecol. 2020;136:411-6).

Her own group at the University of Texas in Houston looked retrospectively at 233 insulin-treated pregnancies complicated by type 2 diabetes and found no significant difference in the rate of neonatal hypoglycemia between those placed on a drip and those who were not, Dr. Bartal said. Over 40% of the newborns had hypoglycemia; it occurred irrespective of the route of delivery as well (J Matern Fetal Neonatal Med. 2022;35:7445-51).

Only two published randomized controlled trials have evaluated blood sugar control in labor, she said. The first, published in 2006, compared a continuous insulin drip with a rotation of glucose and non–glucose-containing fluids in insulin-requiring diabetes and found no differences in maternal blood glucose (the primary outcome) and a similar risk of neonatal hypoglycemia (Am J Obstet Gynecol. 2006;195;1095-9).

The second RCT, published in 2019, evaluated tight versus liberalized control (60-100 mg/dL, checking every hour, versus 60-120 mg/dL, checking every 4 hours) in laboring women with GDM. The first neonatal blood glucose level was similar in both groups, while the mean neonatal blood glucose level in the first 24 hours of life was lower with tight control (54 vs 58 mg/dL, P = .49) (Obstet Gynecol. 2019;133:1171-7). Findings from a new RCT conducted at the University of Texas in Houston of usual care versus more permissive glucose control will be presented at the SMFM Pregnancy Meeting in February 2024, she said.

Neonatal hypoglycemia is associated with increased risk of NICU admission, “but it’s also associated with possible long-term developmental deficit,” Dr. Bartal said, with the risk highest in children exposed to severe, recurrent, or clinically undetected hypoglycemia. Research has documented significantly increased risks of low executive function and visual motor function, for instance, in children who experienced neonatal hypoglycemia.

The risk of neonatal hypoglycemia has been linked to a variety of factors outside of the intrapartum period such as diabetes control and weight gain during pregnancy, neonatal birth weight/LGA, neonatal adiposity, gestational age at delivery, maternal body mass index, smoking, and diabetes control prior to pregnancy, Dr. Bartal noted. Also challenging is the reality that neonatal hypoglycemia as a research outcome is not standardized; definitions have varied across studies.

Tight intrapartum control comes with “costs,” from close monitoring of labor to increased resource utilization, and it may affect the labor experience/satisfaction, Dr. Bartal said. “But furthermore,” she said, “there are studies coming out, especially in the anesthesiology journals, that show there may be possible harm,” such as the risk of maternal and neonatal hyponatremia, and maternal hypoglycemia. A 2016 editorial in Anaesthesia (2016;71:750) describes these concerns, she noted.

“I do think we need to rethink our current recommendations,” she said.

Dr. Durnwald reported serving on the Dexcom GDM advisory board and receiving funding from United Health Group and the Helmsley Charitable Trust. Dr. Bartal and Dr. Rosenn reported no conflicts of interest.

WASHINGTON — Continuous glucose monitoring (CGM) is widely used during pregnancy for individuals with type 1 diabetes — with pregnancy-specific target metrics now chosen and benefits on perinatal outcomes demonstrated — but more research is needed to elucidate its role in the growing population of pregnant people with type 2 diabetes and gestational diabetes (GDM). And overall, there are still “many more questions unanswered about CGM use in pregnancy than what we have answered,” Celeste Durnwald, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

There’s much to learn about how to best interpret “the detailed and complex data that CGM provides,” and what targets in addition to time in range (TIR) are most important, said Dr. Durnwald, director of the perinatal diabetes program and associate professor of ob.gyn. at the Hospital of the University of Pennsylvania, Philadelphia, in a presentation on CGM.

Among other questions are whether fasting glucose is “as important in the era of CGM,” and whether there should be different glycemic targets for nocturnal versus daytime TIR, she said. Moreover, questions justifiably remain about whether the TIR targets for type 1 diabetes in pregnancy are indeed optimal, she said in a discussion period.

Ongoing research is looking at whether CGM can motivate and guide patients with GDM through diet and lifestyle changes such that “we can see changes in amounts of medication we use,” Dr. Durnwald noted in her presentation. “There’s a whole breadth of research looking at whether CGM can help predict diagnosis of GDM, large for gestational age, or preeclampsia, and what are the targets.”

Maternal hypoglycemia during pregnancy — a time when strict glycemic control is recommended to reduce the risk of congenital malformations and other fetal and neonatal morbidity — remains a concern in type 1 diabetes, even with widespread use of CGM in this population, said Barak Rosenn, MD, during a presentation on glycemic control in type 1 diabetes.

A pilot study of a newly designed pregnancy-specific closed-loop insulin delivery system, published last year (Diabetes Care. 2023;46:1425-31), has offered the first “really encouraging information about the ability to use our most up-to-date technology to help our type 1 patients maintain strict control and at the same time decrease their risk of severe hypoglycemia,” said Dr. Rosenn, a maternal-fetal medicine specialist at the Jersey City Medical Center, Jersey City, New Jersey.

Guidance for tight intrapartum glucose control, meanwhile, has been backed by little evidence, said Michal Fishel Bartal, MD, MS, and some recent studies and reviews have shown little to no effect of such tight control on neonatal hypoglycemia, which is the aim of the guidance.

“We need to reexamine current recommendations,” said Dr. Bartal, assistant professor in the division of maternal-fetal medicine at the University of Texas Health Science Center, Houston, during a presentation on intrapartum care. “There’s very limited evidence-based data for the way we manage people with diabetes [during labor and delivery].”

The Knowns And Unknowns of CGM in Pregnancy

The multicenter, international CONCEPTT trial (Continuous Glucose Monitoring in Pregnant Women With Type 1 Diabetes), published in 2017, was the first trial to demonstrate improvements in perinatal outcomes, and it “brought CGM to the forefront in terms of widespread use,” Dr. Durnwald said.

The trial randomized more than 300 patients with type 1 diabetes who were pregnant or planning pregnancy (both users of insulin pumps and users of multiple insulin injections) to continuous, real-time CGM in addition to finger-stick glucose monitoring, or standard finger-stick glucose tests alone. In addition to small improvements in A1c and 7% more TIR (without an increase in hypoglycemia), pregnant CGM users had reductions in large-for-gestational age (LGA) births (53% vs 69%, P = .0489), neonatal intensive care admissions lasting more than 24 hours, and severe neonatal hypoglycemia.

Numbers needed to treat to prevent adverse outcomes in the CONCEPTT trial were six for LGA, six for NICU admission, and eight for neonatal hypoglycemia.

Data from the CONCEPTT trial featured prominently in the development of consensus recommendations for CGM targets in pregnancy by an international expert panel endorsed by the American Diabetes Association. In its 2019 report, the group recommended a target range of 63-140 mg/dL for type 1 and type 2 diabetes during pregnancy (compared with 70-180 mg/dL outside of pregnancy), and a TIR > 70% for pregnant people with type 1 diabetes. (Targets for time below range and time above range are also defined for type 1.)

More data are needed, the group said, in order to recommend TIR targets for type 2 diabetes in pregnancy or GDM (Diabetes Care. 2019;42:1593-603). “Many argue,” Dr. Durnwald said, “that there could be more stringent targets for those at less risk for [maternal] hypoglycemia, especially our GDM population.”

There’s a question of whether even higher TIR would further improve perinatal outcomes, she said, “or will we reach a threshold where higher TIR doesn’t get us a [further] reduction in LGA or preeclampsia.”

And while TIR is “certainly our buzzword,” lower mean glucose levels have also been associated with a lower risk of LGA and other adverse neonatal outcomes. A 2019 retrospective study from Sweden, for instance, analyzed patterns of CGM data from 186 pregnant women with type 1 diabetes and found significant associations between elevated mean glucose levels (in the second and third trimesters) and both LGA and an adverse neonatal composite outcome (Diabetologia. 2019;62:1143-53).

Elevated TIR was also associated with LGA, but “mean glucose had the strongest association with the rate of LGA,” Dr. Durnwald said.

Similarly, a 2020 subanalysis of the CONCEPTT trial data found that a higher mean glucose at both 24 and 34 weeks of gestation was significantly associated with a greater risk of LGA (Diabetes Care. 2020;43:1178-84), and a smaller 2015 analysis of data from two randomized controlled trials of CGM in pregnant women with type 1 and type 2 diabetes found this association in trimesters 2 and 3 (Diabetes Care. 2015;38;1319-25).

The ADA’s Standards of Care in Diabetes (Diabetes Care. 2024;47:S282-S294) endorse CGM as an adjunctive tool in pregnancy — not as a replacement for all traditional blood glucose monitoring — and advise that the use of CGM-reported mean glucose is superior to the use of estimated A1c, glucose management indicator, and other calculations to estimate A1c. Changes occur in pregnancy, Dr. Durnwald pointed out. “Most experts will identify a [target] mean glucose < 120 mg/dL in those with type 1, but there’s potential to have a mean glucose closer to 100 in certainly our patients with GDM and some of our patients with type 2,” she said. To a lesser extent, researchers have also looked at the effect of CMG-reported glycemic variability on outcomes such as LGA, with at least two studies finding some association, and there has been some research on nocturnal glucose and LGA, Dr. Durnwald said. CGM “gives us the opportunity,” she said, “to think about nocturnal glucose as a possible target” for further optimizing diabetes management during pregnancy.

CGM in Type 2, GDM

CGM in type 2 diabetes in pregnancy was addressed in a recently published systematic review and meta-analysis, which found only three qualifying randomized controlled trials and concluded that CGM use was not associated with improvements in perinatal outcomes, as assessed by LGA and preeclampsia (Am J Obstet Gynecol MFM. 2023;5:100969). “It’s very limited by the small sample size and the fact that most [patients] were using intermittent CGM,” Dr. Durnwald said. “It highlights how important it is to perform larger studies with continuous CGM.”

While the 2024 ADA standards say there are insufficient data to support the use of CGM in all patients with type 2 diabetes or GDM — and that the decision should be individualized “based on treatment regimen, circumstance, preferences, and needs” — real-world access to CGM for type 2, and even a bit for GDM, is improving, she said.

Some insurers require patients to be on insulin, but the trends are such that “we certainly talk about CGM to all our patients with type 2 diabetes and even our patients with GDM,” Dr. Durnwald said in a later interview. “CGMs are being advertised so we definitely have people who ask about them upon diagnosis, and we try to make it work for them.”
 

Is Preventing Maternal Hypoglycemia Possible?

Advancements in technology and pharmacology aimed at optimizing glycemic control — increased adoption of CGM, the use of insulin pump therapy, and the use of more rapid insulin analogs — appear to have had little to no impact on rates of severe maternal hypoglycemia in type 1 diabetes in pregnancy, said Dr. Rosenn, referring to several published studies.

The CONCEPTT study in type 1 diabetes, for instance, “gave us the best data we have on the use of CGM,” but differences in the percentage of patients with severe hypoglycemia and the total number of severe hypoglycemia episodes were basically the same whether patients used CGM or not, he said.

Closed-loop insulin delivery systems have been found in nonpregnant patients with type 1 diabetes to “be helpful in keeping people in range and also possibly [decreasing nocturnal hypoglycemia],” but the systems are not approved for use in pregnancy. “There’s not enough data on use in pregnancy, but probably more important, the algorithms used in the closed-loop systems are not directed to the targets we consider ideal for pregnancy,” Dr. Rosenn said.

In a pilot study of a closed-loop delivery system customized for pregnancies complicated by type 1 diabetes, 10 pregnant women were recruited at 14-32 weeks and, after a 1- to 2-week run-in period using a regular CGM-augmented pump, they used the closed-loop system targeting a daytime glucose of 80-110 mg/dL and nocturnal glucose of 80-100 mg/dL.

Mean TIR (a target range of 63-140 mg/dL) increased from 65% during the run-in period to 79% on the closed-loop system, and there were significant decreases in both time above range and time in the hypoglycemic ranges of < 63 mg/dL and < 54 mg/dL. Hypoglycemic events per week (defined as < 54 mg/dL for over 15 minutes) decreased from 4 to 0.7 (Diabetes Care. 2023;46:1425-31).

The investigators are continuing their research, and there are currently two randomized controlled trials underway examining use of closed-loop systems designed for pregnancy, said Dr. Rosenn, who was involved in feasibility research leading up to the pilot study. “So I’m hopeful we’ll see some encouraging information in the future.”

Maternal hypoglycemia during pregnancy is more common in type 1 diabetes, but it also affects pregnancies complicated by type 2 diabetes and GDM. In addition to the strict glycemic control imposed to improve maternal and fetal outcomes, pregnancy itself plays a role.

Research several decades ago from the Diabetes in Pregnancy Program Project, a prospective cohort in Cincinnati which Dr. Rosenn co-led, documented impaired counterregulatory physiology in pregnancy. Even in nondiabetic patients, there are declines in secretion of glucagon and growth hormone in response to hypoglycemia, for instance. In patients with type 1 diabetes, the diminishment in counterregulatory response is more severe.

Rethinking Intrapartum Care

Guidance for tight blood glucose control during labor and delivery for insulin-treated individuals — as reflected in the American College of Obstetricians and Gynecologists Practice Bulletin No. 201 on Pregestational Diabetes and in recommendations from the United Kingdom’s National Institute for Health and Care Excellence (NICE) — is based on small case series and overall “poor-quality” evidence that more recent research has failed to back up, Dr. Bartal said.

A systematic review published in 2018, for example, concluded there is a paucity of high-quality data supporting the association of glucose during labor and delivery with neonatal hypoglycemia in pregnancies complicated by diabetes (Diabet Med. 2018;35:173-83). And in a subsequent retrospective cohort study of pregnant women with type 1/type 2/GDM and their neonates, the same investigators reported no difference in the target glucose in labor between those with and without neonatal hypotension, after adjustment for important neonatal factors such as LGA and preterm delivery (Diabet Med. 2020;37:138-46).

Also exemplifying the body of research, Dr. Bartal said, is another single-center retrospective study published in 2020 that evaluated outcomes in the years before and after the institution of a formal intrapartum insulin regimen (a standardized protocol for titration of insulin and glucose infusions) for women with pregestational or gestational diabetes. The protocol was associated with improved maternal glucose control, but an increased frequency of neonatal hypoglycemia (Obstet Gynecol. 2020;136:411-6).

Her own group at the University of Texas in Houston looked retrospectively at 233 insulin-treated pregnancies complicated by type 2 diabetes and found no significant difference in the rate of neonatal hypoglycemia between those placed on a drip and those who were not, Dr. Bartal said. Over 40% of the newborns had hypoglycemia; it occurred irrespective of the route of delivery as well (J Matern Fetal Neonatal Med. 2022;35:7445-51).

Only two published randomized controlled trials have evaluated blood sugar control in labor, she said. The first, published in 2006, compared a continuous insulin drip with a rotation of glucose and non–glucose-containing fluids in insulin-requiring diabetes and found no differences in maternal blood glucose (the primary outcome) and a similar risk of neonatal hypoglycemia (Am J Obstet Gynecol. 2006;195;1095-9).

The second RCT, published in 2019, evaluated tight versus liberalized control (60-100 mg/dL, checking every hour, versus 60-120 mg/dL, checking every 4 hours) in laboring women with GDM. The first neonatal blood glucose level was similar in both groups, while the mean neonatal blood glucose level in the first 24 hours of life was lower with tight control (54 vs 58 mg/dL, P = .49) (Obstet Gynecol. 2019;133:1171-7). Findings from a new RCT conducted at the University of Texas in Houston of usual care versus more permissive glucose control will be presented at the SMFM Pregnancy Meeting in February 2024, she said.

Neonatal hypoglycemia is associated with increased risk of NICU admission, “but it’s also associated with possible long-term developmental deficit,” Dr. Bartal said, with the risk highest in children exposed to severe, recurrent, or clinically undetected hypoglycemia. Research has documented significantly increased risks of low executive function and visual motor function, for instance, in children who experienced neonatal hypoglycemia.

The risk of neonatal hypoglycemia has been linked to a variety of factors outside of the intrapartum period such as diabetes control and weight gain during pregnancy, neonatal birth weight/LGA, neonatal adiposity, gestational age at delivery, maternal body mass index, smoking, and diabetes control prior to pregnancy, Dr. Bartal noted. Also challenging is the reality that neonatal hypoglycemia as a research outcome is not standardized; definitions have varied across studies.

Tight intrapartum control comes with “costs,” from close monitoring of labor to increased resource utilization, and it may affect the labor experience/satisfaction, Dr. Bartal said. “But furthermore,” she said, “there are studies coming out, especially in the anesthesiology journals, that show there may be possible harm,” such as the risk of maternal and neonatal hyponatremia, and maternal hypoglycemia. A 2016 editorial in Anaesthesia (2016;71:750) describes these concerns, she noted.

“I do think we need to rethink our current recommendations,” she said.

Dr. Durnwald reported serving on the Dexcom GDM advisory board and receiving funding from United Health Group and the Helmsley Charitable Trust. Dr. Bartal and Dr. Rosenn reported no conflicts of interest.

WASHINGTON — Continuous glucose monitoring (CGM) is widely used during pregnancy for individuals with type 1 diabetes — with pregnancy-specific target metrics now chosen and benefits on perinatal outcomes demonstrated — but more research is needed to elucidate its role in the growing population of pregnant people with type 2 diabetes and gestational diabetes (GDM). And overall, there are still “many more questions unanswered about CGM use in pregnancy than what we have answered,” Celeste Durnwald, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

There’s much to learn about how to best interpret “the detailed and complex data that CGM provides,” and what targets in addition to time in range (TIR) are most important, said Dr. Durnwald, director of the perinatal diabetes program and associate professor of ob.gyn. at the Hospital of the University of Pennsylvania, Philadelphia, in a presentation on CGM.

Among other questions are whether fasting glucose is “as important in the era of CGM,” and whether there should be different glycemic targets for nocturnal versus daytime TIR, she said. Moreover, questions justifiably remain about whether the TIR targets for type 1 diabetes in pregnancy are indeed optimal, she said in a discussion period.

Ongoing research is looking at whether CGM can motivate and guide patients with GDM through diet and lifestyle changes such that “we can see changes in amounts of medication we use,” Dr. Durnwald noted in her presentation. “There’s a whole breadth of research looking at whether CGM can help predict diagnosis of GDM, large for gestational age, or preeclampsia, and what are the targets.”

Maternal hypoglycemia during pregnancy — a time when strict glycemic control is recommended to reduce the risk of congenital malformations and other fetal and neonatal morbidity — remains a concern in type 1 diabetes, even with widespread use of CGM in this population, said Barak Rosenn, MD, during a presentation on glycemic control in type 1 diabetes.

A pilot study of a newly designed pregnancy-specific closed-loop insulin delivery system, published last year (Diabetes Care. 2023;46:1425-31), has offered the first “really encouraging information about the ability to use our most up-to-date technology to help our type 1 patients maintain strict control and at the same time decrease their risk of severe hypoglycemia,” said Dr. Rosenn, a maternal-fetal medicine specialist at the Jersey City Medical Center, Jersey City, New Jersey.

Guidance for tight intrapartum glucose control, meanwhile, has been backed by little evidence, said Michal Fishel Bartal, MD, MS, and some recent studies and reviews have shown little to no effect of such tight control on neonatal hypoglycemia, which is the aim of the guidance.

“We need to reexamine current recommendations,” said Dr. Bartal, assistant professor in the division of maternal-fetal medicine at the University of Texas Health Science Center, Houston, during a presentation on intrapartum care. “There’s very limited evidence-based data for the way we manage people with diabetes [during labor and delivery].”

The Knowns And Unknowns of CGM in Pregnancy

The multicenter, international CONCEPTT trial (Continuous Glucose Monitoring in Pregnant Women With Type 1 Diabetes), published in 2017, was the first trial to demonstrate improvements in perinatal outcomes, and it “brought CGM to the forefront in terms of widespread use,” Dr. Durnwald said.

The trial randomized more than 300 patients with type 1 diabetes who were pregnant or planning pregnancy (both users of insulin pumps and users of multiple insulin injections) to continuous, real-time CGM in addition to finger-stick glucose monitoring, or standard finger-stick glucose tests alone. In addition to small improvements in A1c and 7% more TIR (without an increase in hypoglycemia), pregnant CGM users had reductions in large-for-gestational age (LGA) births (53% vs 69%, P = .0489), neonatal intensive care admissions lasting more than 24 hours, and severe neonatal hypoglycemia.

Numbers needed to treat to prevent adverse outcomes in the CONCEPTT trial were six for LGA, six for NICU admission, and eight for neonatal hypoglycemia.

Data from the CONCEPTT trial featured prominently in the development of consensus recommendations for CGM targets in pregnancy by an international expert panel endorsed by the American Diabetes Association. In its 2019 report, the group recommended a target range of 63-140 mg/dL for type 1 and type 2 diabetes during pregnancy (compared with 70-180 mg/dL outside of pregnancy), and a TIR > 70% for pregnant people with type 1 diabetes. (Targets for time below range and time above range are also defined for type 1.)

More data are needed, the group said, in order to recommend TIR targets for type 2 diabetes in pregnancy or GDM (Diabetes Care. 2019;42:1593-603). “Many argue,” Dr. Durnwald said, “that there could be more stringent targets for those at less risk for [maternal] hypoglycemia, especially our GDM population.”

There’s a question of whether even higher TIR would further improve perinatal outcomes, she said, “or will we reach a threshold where higher TIR doesn’t get us a [further] reduction in LGA or preeclampsia.”

And while TIR is “certainly our buzzword,” lower mean glucose levels have also been associated with a lower risk of LGA and other adverse neonatal outcomes. A 2019 retrospective study from Sweden, for instance, analyzed patterns of CGM data from 186 pregnant women with type 1 diabetes and found significant associations between elevated mean glucose levels (in the second and third trimesters) and both LGA and an adverse neonatal composite outcome (Diabetologia. 2019;62:1143-53).

Elevated TIR was also associated with LGA, but “mean glucose had the strongest association with the rate of LGA,” Dr. Durnwald said.

Similarly, a 2020 subanalysis of the CONCEPTT trial data found that a higher mean glucose at both 24 and 34 weeks of gestation was significantly associated with a greater risk of LGA (Diabetes Care. 2020;43:1178-84), and a smaller 2015 analysis of data from two randomized controlled trials of CGM in pregnant women with type 1 and type 2 diabetes found this association in trimesters 2 and 3 (Diabetes Care. 2015;38;1319-25).

The ADA’s Standards of Care in Diabetes (Diabetes Care. 2024;47:S282-S294) endorse CGM as an adjunctive tool in pregnancy — not as a replacement for all traditional blood glucose monitoring — and advise that the use of CGM-reported mean glucose is superior to the use of estimated A1c, glucose management indicator, and other calculations to estimate A1c. Changes occur in pregnancy, Dr. Durnwald pointed out. “Most experts will identify a [target] mean glucose < 120 mg/dL in those with type 1, but there’s potential to have a mean glucose closer to 100 in certainly our patients with GDM and some of our patients with type 2,” she said. To a lesser extent, researchers have also looked at the effect of CMG-reported glycemic variability on outcomes such as LGA, with at least two studies finding some association, and there has been some research on nocturnal glucose and LGA, Dr. Durnwald said. CGM “gives us the opportunity,” she said, “to think about nocturnal glucose as a possible target” for further optimizing diabetes management during pregnancy.

CGM in Type 2, GDM

CGM in type 2 diabetes in pregnancy was addressed in a recently published systematic review and meta-analysis, which found only three qualifying randomized controlled trials and concluded that CGM use was not associated with improvements in perinatal outcomes, as assessed by LGA and preeclampsia (Am J Obstet Gynecol MFM. 2023;5:100969). “It’s very limited by the small sample size and the fact that most [patients] were using intermittent CGM,” Dr. Durnwald said. “It highlights how important it is to perform larger studies with continuous CGM.”

While the 2024 ADA standards say there are insufficient data to support the use of CGM in all patients with type 2 diabetes or GDM — and that the decision should be individualized “based on treatment regimen, circumstance, preferences, and needs” — real-world access to CGM for type 2, and even a bit for GDM, is improving, she said.

Some insurers require patients to be on insulin, but the trends are such that “we certainly talk about CGM to all our patients with type 2 diabetes and even our patients with GDM,” Dr. Durnwald said in a later interview. “CGMs are being advertised so we definitely have people who ask about them upon diagnosis, and we try to make it work for them.”
 

Is Preventing Maternal Hypoglycemia Possible?

Advancements in technology and pharmacology aimed at optimizing glycemic control — increased adoption of CGM, the use of insulin pump therapy, and the use of more rapid insulin analogs — appear to have had little to no impact on rates of severe maternal hypoglycemia in type 1 diabetes in pregnancy, said Dr. Rosenn, referring to several published studies.

The CONCEPTT study in type 1 diabetes, for instance, “gave us the best data we have on the use of CGM,” but differences in the percentage of patients with severe hypoglycemia and the total number of severe hypoglycemia episodes were basically the same whether patients used CGM or not, he said.

Closed-loop insulin delivery systems have been found in nonpregnant patients with type 1 diabetes to “be helpful in keeping people in range and also possibly [decreasing nocturnal hypoglycemia],” but the systems are not approved for use in pregnancy. “There’s not enough data on use in pregnancy, but probably more important, the algorithms used in the closed-loop systems are not directed to the targets we consider ideal for pregnancy,” Dr. Rosenn said.

In a pilot study of a closed-loop delivery system customized for pregnancies complicated by type 1 diabetes, 10 pregnant women were recruited at 14-32 weeks and, after a 1- to 2-week run-in period using a regular CGM-augmented pump, they used the closed-loop system targeting a daytime glucose of 80-110 mg/dL and nocturnal glucose of 80-100 mg/dL.

Mean TIR (a target range of 63-140 mg/dL) increased from 65% during the run-in period to 79% on the closed-loop system, and there were significant decreases in both time above range and time in the hypoglycemic ranges of < 63 mg/dL and < 54 mg/dL. Hypoglycemic events per week (defined as < 54 mg/dL for over 15 minutes) decreased from 4 to 0.7 (Diabetes Care. 2023;46:1425-31).

The investigators are continuing their research, and there are currently two randomized controlled trials underway examining use of closed-loop systems designed for pregnancy, said Dr. Rosenn, who was involved in feasibility research leading up to the pilot study. “So I’m hopeful we’ll see some encouraging information in the future.”

Maternal hypoglycemia during pregnancy is more common in type 1 diabetes, but it also affects pregnancies complicated by type 2 diabetes and GDM. In addition to the strict glycemic control imposed to improve maternal and fetal outcomes, pregnancy itself plays a role.

Research several decades ago from the Diabetes in Pregnancy Program Project, a prospective cohort in Cincinnati which Dr. Rosenn co-led, documented impaired counterregulatory physiology in pregnancy. Even in nondiabetic patients, there are declines in secretion of glucagon and growth hormone in response to hypoglycemia, for instance. In patients with type 1 diabetes, the diminishment in counterregulatory response is more severe.

Rethinking Intrapartum Care

Guidance for tight blood glucose control during labor and delivery for insulin-treated individuals — as reflected in the American College of Obstetricians and Gynecologists Practice Bulletin No. 201 on Pregestational Diabetes and in recommendations from the United Kingdom’s National Institute for Health and Care Excellence (NICE) — is based on small case series and overall “poor-quality” evidence that more recent research has failed to back up, Dr. Bartal said.

A systematic review published in 2018, for example, concluded there is a paucity of high-quality data supporting the association of glucose during labor and delivery with neonatal hypoglycemia in pregnancies complicated by diabetes (Diabet Med. 2018;35:173-83). And in a subsequent retrospective cohort study of pregnant women with type 1/type 2/GDM and their neonates, the same investigators reported no difference in the target glucose in labor between those with and without neonatal hypotension, after adjustment for important neonatal factors such as LGA and preterm delivery (Diabet Med. 2020;37:138-46).

Also exemplifying the body of research, Dr. Bartal said, is another single-center retrospective study published in 2020 that evaluated outcomes in the years before and after the institution of a formal intrapartum insulin regimen (a standardized protocol for titration of insulin and glucose infusions) for women with pregestational or gestational diabetes. The protocol was associated with improved maternal glucose control, but an increased frequency of neonatal hypoglycemia (Obstet Gynecol. 2020;136:411-6).

Her own group at the University of Texas in Houston looked retrospectively at 233 insulin-treated pregnancies complicated by type 2 diabetes and found no significant difference in the rate of neonatal hypoglycemia between those placed on a drip and those who were not, Dr. Bartal said. Over 40% of the newborns had hypoglycemia; it occurred irrespective of the route of delivery as well (J Matern Fetal Neonatal Med. 2022;35:7445-51).

Only two published randomized controlled trials have evaluated blood sugar control in labor, she said. The first, published in 2006, compared a continuous insulin drip with a rotation of glucose and non–glucose-containing fluids in insulin-requiring diabetes and found no differences in maternal blood glucose (the primary outcome) and a similar risk of neonatal hypoglycemia (Am J Obstet Gynecol. 2006;195;1095-9).

The second RCT, published in 2019, evaluated tight versus liberalized control (60-100 mg/dL, checking every hour, versus 60-120 mg/dL, checking every 4 hours) in laboring women with GDM. The first neonatal blood glucose level was similar in both groups, while the mean neonatal blood glucose level in the first 24 hours of life was lower with tight control (54 vs 58 mg/dL, P = .49) (Obstet Gynecol. 2019;133:1171-7). Findings from a new RCT conducted at the University of Texas in Houston of usual care versus more permissive glucose control will be presented at the SMFM Pregnancy Meeting in February 2024, she said.

Neonatal hypoglycemia is associated with increased risk of NICU admission, “but it’s also associated with possible long-term developmental deficit,” Dr. Bartal said, with the risk highest in children exposed to severe, recurrent, or clinically undetected hypoglycemia. Research has documented significantly increased risks of low executive function and visual motor function, for instance, in children who experienced neonatal hypoglycemia.

The risk of neonatal hypoglycemia has been linked to a variety of factors outside of the intrapartum period such as diabetes control and weight gain during pregnancy, neonatal birth weight/LGA, neonatal adiposity, gestational age at delivery, maternal body mass index, smoking, and diabetes control prior to pregnancy, Dr. Bartal noted. Also challenging is the reality that neonatal hypoglycemia as a research outcome is not standardized; definitions have varied across studies.

Tight intrapartum control comes with “costs,” from close monitoring of labor to increased resource utilization, and it may affect the labor experience/satisfaction, Dr. Bartal said. “But furthermore,” she said, “there are studies coming out, especially in the anesthesiology journals, that show there may be possible harm,” such as the risk of maternal and neonatal hyponatremia, and maternal hypoglycemia. A 2016 editorial in Anaesthesia (2016;71:750) describes these concerns, she noted.

“I do think we need to rethink our current recommendations,” she said.

Dr. Durnwald reported serving on the Dexcom GDM advisory board and receiving funding from United Health Group and the Helmsley Charitable Trust. Dr. Bartal and Dr. Rosenn reported no conflicts of interest.

Exposure to even moderate concentrations of radon is associated with a significant increase in stroke risk, new research suggests.

An analysis of radon exposures in more than 150,000 postmenopausal women in the Women’s Health Initiative revealed a 14% higher stroke risk in those exposed to the highest concentrations compared with those exposed to the lowest concentrations. Even moderate concentrations of radon were associated with a 6% higher stroke risk.

Radon is the second leading cause of lung cancer, but little was known about how exposure to the gas might affect stroke risk in women. 

“Our research found an increased risk of stroke among participants exposed to radon above — and as many as 2 picocuries per liter (pCi/L) below — concentrations that usually trigger Environmental Protection Agency recommendations to install a home radon mitigation system,” senior author Eric A. Whitsel, MD, MPH, professor of epidemiology and medicine, University of North Carolina, Chapel Hill, said in a news release.

The study was published online on January 31, 2024, in Neurology.

Women Particularly Affected

Radon is a naturally occurring odorless radioactive gas produced when uranium or radium break down in rocks and soil. Its presence is increasing as a result of climate change, and it is increasingly being found in people’s homes. When inhaled, this air pollutant releases ionizing radiation in the lungs and is seen as second only to smoking as an established cause of lung cancer.

The National Radon Action Plan of the US Environmental Protection Agency (EPA) lays out testing and mitigation guidelines based on the known role of radon in lung carcinogenesis. But radon testing and mitigation are less common than recommended, and the EPA’s action plan doesn’t cover diseases other than lung cancer.

Compared with men, women have a higher rate of stroke and, in the US, typically spend about 11% more hours per day indoors at home, which investigators note highlights a “potential role of the residential environment among other risk factors specific to women.”

Researchers examined longitudinal associations between home radon exposure and incident stroke in 158,910 women at baseline (mean age 63.2 years; 83% White) over a mean follow-up of 13.4 years. During this time, participants experienced a total of 6979 strokes.

Participants’ home addresses were linked to radon concentration data drawn from the US Geological Survey and the EPA, which recommends that average indoor radon concentrations not exceed 4 pCi/L. 

The highest radon exposure group resided in areas where average radon concentrations were < 4 pCi/L; the middle exposure group lived in regions with average concentrations of 2-4 pCi/L; and the lowest exposure group lived in areas with average concentrations < 2 pCi/L. 

The researchers adjusted for demographic, social, behavioral, and clinical characteristics.

Public Health Implications

The incidence rates of stroke per 100,000 women in the lowest, middle, and highest radon concentration areas were 333, 343, and 349, respectively.

Stroke risk was 6% higher among those in the middle exposure group (adjusted hazard ratio [aHR], 1.06; 95% CI, 0.99-1.13) and 14% higher in the highest exposure group (aHR, 1.14; 95% CI, 1.05-1.22) compared with the lowest exposure group.

Notably, stroke risk was significant even at concentrations ranging from 2 to 4 pCi/L (P = .0004) vs < 2 pCi/L, which is below the EPA›s Radon Action Level for mitigation. 

The findings remained robust in sensitivity analyses, although the associations were slightly stronger for ischemic stroke (especially cardioembolic, small-vessel occlusive, and very large artery atherosclerotic) compared with hemorrhagic stroke.

“Radon is an indoor air pollutant that can only be detected through testing that measures concentrations of the gas in homes,” Dr. Whitsel said in the release. “More studies are needed to confirm our findings. Confirmation would present an opportunity to improve public health by addressing an emerging risk factor for stroke.”

The study lacked gender and racial/ethnic diversity, so the findings may not be generalizable to other populations. 

“Replication studies of individual-level radon exposures are needed to confirm this positive radon-stroke association,” the authors write. “Confirmation would present a potential opportunity to affect public health by addressing a pervasive environmental risk factor for stroke and thereby merit reconsideration of extant radon policy.”

The study was funded by the National Institute of Environmental Health Sciences and National Heart, Lung, and Blood Institute. Dr. Whitsel and coauthors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Exposure to even moderate concentrations of radon is associated with a significant increase in stroke risk, new research suggests.

An analysis of radon exposures in more than 150,000 postmenopausal women in the Women’s Health Initiative revealed a 14% higher stroke risk in those exposed to the highest concentrations compared with those exposed to the lowest concentrations. Even moderate concentrations of radon were associated with a 6% higher stroke risk.

Radon is the second leading cause of lung cancer, but little was known about how exposure to the gas might affect stroke risk in women. 

“Our research found an increased risk of stroke among participants exposed to radon above — and as many as 2 picocuries per liter (pCi/L) below — concentrations that usually trigger Environmental Protection Agency recommendations to install a home radon mitigation system,” senior author Eric A. Whitsel, MD, MPH, professor of epidemiology and medicine, University of North Carolina, Chapel Hill, said in a news release.

The study was published online on January 31, 2024, in Neurology.

Women Particularly Affected

Radon is a naturally occurring odorless radioactive gas produced when uranium or radium break down in rocks and soil. Its presence is increasing as a result of climate change, and it is increasingly being found in people’s homes. When inhaled, this air pollutant releases ionizing radiation in the lungs and is seen as second only to smoking as an established cause of lung cancer.

The National Radon Action Plan of the US Environmental Protection Agency (EPA) lays out testing and mitigation guidelines based on the known role of radon in lung carcinogenesis. But radon testing and mitigation are less common than recommended, and the EPA’s action plan doesn’t cover diseases other than lung cancer.

Compared with men, women have a higher rate of stroke and, in the US, typically spend about 11% more hours per day indoors at home, which investigators note highlights a “potential role of the residential environment among other risk factors specific to women.”

Researchers examined longitudinal associations between home radon exposure and incident stroke in 158,910 women at baseline (mean age 63.2 years; 83% White) over a mean follow-up of 13.4 years. During this time, participants experienced a total of 6979 strokes.

Participants’ home addresses were linked to radon concentration data drawn from the US Geological Survey and the EPA, which recommends that average indoor radon concentrations not exceed 4 pCi/L. 

The highest radon exposure group resided in areas where average radon concentrations were < 4 pCi/L; the middle exposure group lived in regions with average concentrations of 2-4 pCi/L; and the lowest exposure group lived in areas with average concentrations < 2 pCi/L. 

The researchers adjusted for demographic, social, behavioral, and clinical characteristics.

Public Health Implications

The incidence rates of stroke per 100,000 women in the lowest, middle, and highest radon concentration areas were 333, 343, and 349, respectively.

Stroke risk was 6% higher among those in the middle exposure group (adjusted hazard ratio [aHR], 1.06; 95% CI, 0.99-1.13) and 14% higher in the highest exposure group (aHR, 1.14; 95% CI, 1.05-1.22) compared with the lowest exposure group.

Notably, stroke risk was significant even at concentrations ranging from 2 to 4 pCi/L (P = .0004) vs < 2 pCi/L, which is below the EPA›s Radon Action Level for mitigation. 

The findings remained robust in sensitivity analyses, although the associations were slightly stronger for ischemic stroke (especially cardioembolic, small-vessel occlusive, and very large artery atherosclerotic) compared with hemorrhagic stroke.

“Radon is an indoor air pollutant that can only be detected through testing that measures concentrations of the gas in homes,” Dr. Whitsel said in the release. “More studies are needed to confirm our findings. Confirmation would present an opportunity to improve public health by addressing an emerging risk factor for stroke.”

The study lacked gender and racial/ethnic diversity, so the findings may not be generalizable to other populations. 

“Replication studies of individual-level radon exposures are needed to confirm this positive radon-stroke association,” the authors write. “Confirmation would present a potential opportunity to affect public health by addressing a pervasive environmental risk factor for stroke and thereby merit reconsideration of extant radon policy.”

The study was funded by the National Institute of Environmental Health Sciences and National Heart, Lung, and Blood Institute. Dr. Whitsel and coauthors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Exposure to even moderate concentrations of radon is associated with a significant increase in stroke risk, new research suggests.

An analysis of radon exposures in more than 150,000 postmenopausal women in the Women’s Health Initiative revealed a 14% higher stroke risk in those exposed to the highest concentrations compared with those exposed to the lowest concentrations. Even moderate concentrations of radon were associated with a 6% higher stroke risk.

Radon is the second leading cause of lung cancer, but little was known about how exposure to the gas might affect stroke risk in women. 

“Our research found an increased risk of stroke among participants exposed to radon above — and as many as 2 picocuries per liter (pCi/L) below — concentrations that usually trigger Environmental Protection Agency recommendations to install a home radon mitigation system,” senior author Eric A. Whitsel, MD, MPH, professor of epidemiology and medicine, University of North Carolina, Chapel Hill, said in a news release.

The study was published online on January 31, 2024, in Neurology.

Women Particularly Affected

Radon is a naturally occurring odorless radioactive gas produced when uranium or radium break down in rocks and soil. Its presence is increasing as a result of climate change, and it is increasingly being found in people’s homes. When inhaled, this air pollutant releases ionizing radiation in the lungs and is seen as second only to smoking as an established cause of lung cancer.

The National Radon Action Plan of the US Environmental Protection Agency (EPA) lays out testing and mitigation guidelines based on the known role of radon in lung carcinogenesis. But radon testing and mitigation are less common than recommended, and the EPA’s action plan doesn’t cover diseases other than lung cancer.

Compared with men, women have a higher rate of stroke and, in the US, typically spend about 11% more hours per day indoors at home, which investigators note highlights a “potential role of the residential environment among other risk factors specific to women.”

Researchers examined longitudinal associations between home radon exposure and incident stroke in 158,910 women at baseline (mean age 63.2 years; 83% White) over a mean follow-up of 13.4 years. During this time, participants experienced a total of 6979 strokes.

Participants’ home addresses were linked to radon concentration data drawn from the US Geological Survey and the EPA, which recommends that average indoor radon concentrations not exceed 4 pCi/L. 

The highest radon exposure group resided in areas where average radon concentrations were < 4 pCi/L; the middle exposure group lived in regions with average concentrations of 2-4 pCi/L; and the lowest exposure group lived in areas with average concentrations < 2 pCi/L. 

The researchers adjusted for demographic, social, behavioral, and clinical characteristics.

Public Health Implications

The incidence rates of stroke per 100,000 women in the lowest, middle, and highest radon concentration areas were 333, 343, and 349, respectively.

Stroke risk was 6% higher among those in the middle exposure group (adjusted hazard ratio [aHR], 1.06; 95% CI, 0.99-1.13) and 14% higher in the highest exposure group (aHR, 1.14; 95% CI, 1.05-1.22) compared with the lowest exposure group.

Notably, stroke risk was significant even at concentrations ranging from 2 to 4 pCi/L (P = .0004) vs < 2 pCi/L, which is below the EPA›s Radon Action Level for mitigation. 

The findings remained robust in sensitivity analyses, although the associations were slightly stronger for ischemic stroke (especially cardioembolic, small-vessel occlusive, and very large artery atherosclerotic) compared with hemorrhagic stroke.

“Radon is an indoor air pollutant that can only be detected through testing that measures concentrations of the gas in homes,” Dr. Whitsel said in the release. “More studies are needed to confirm our findings. Confirmation would present an opportunity to improve public health by addressing an emerging risk factor for stroke.”

The study lacked gender and racial/ethnic diversity, so the findings may not be generalizable to other populations. 

“Replication studies of individual-level radon exposures are needed to confirm this positive radon-stroke association,” the authors write. “Confirmation would present a potential opportunity to affect public health by addressing a pervasive environmental risk factor for stroke and thereby merit reconsideration of extant radon policy.”

The study was funded by the National Institute of Environmental Health Sciences and National Heart, Lung, and Blood Institute. Dr. Whitsel and coauthors report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

Comorbidities may play a large role in driving poor pregnancy outcomes in pregnant people with certain immune-mediated inflammatory diseases (IMIDs).

In a new study of 12 individual IMIDs, people with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD) did not have signficantly increased risk for preterm birth (PTB) or low birth weight (LBW), compared with people who did not have an IMID, after adjusting for additional chronic conditions and other confounding factors.

The study was published online on February 1 in eClinicalMedicine.

While many studies have explored the relationships between pregnancy outcomes and IMIDs, “the impact of comorbidities on the relation between IMIDs and pregnancy course is insufficiently examined,” the authors wrote. These previous studies also tended to have a small sample size.
 

Pregnancy Outcome Risks Varied Between IMIDs

To remedy this, researchers used electronic health record data from Providence St Joseph Health — a multistate integrated healthcare system — to identify more than 365,000 pregnant people with live births between January 1, 2013, and December 31, 2022. The cohort included more than 5700 people with at least one of 12 IMIDs: Psoriasis, IBD, RA, spondyloarthritis (SpA), multiple sclerosis, systemic lupus erythematosus (SLE), psoriatic arthritis (PsA), antiphospholipid syndrome (APS), Sjögren syndrome (SjS), vasculitis, sarcoidosis, and systemic sclerosis. The study included only live births with a gestational age of 20 weeks or greater.

Researchers compared maternal-fetal health outcomes between the two groups, controlling for comorbidities including diabetes, cardiovascular disease, chronic kidney disease, obesity, and depression. They also accounted for confounding variables including race, age, smoking status, and socioeconomic status.

In total, 83% of people in the IMID group had no immunomodulatory medication prescriptions during their pregnancy. Of the 17% taking medication, 48%-70% continued taking their medication until delivery. Most patients were White, comprising 62.9% of the non-IMID group and 73.1% of the IMID group.

After adjusting for comorbidities, patients with any of the 12 IMIDs had a 10%-20% higher risk for PTB, LBW, small for gestation age (SGA), and cesarean section than did comparators.

But these risks varied between IMIDs. Patients with RA and IBD did not have an increased risk for PTB or LBW. However, when researchers did not control for comorbidities, pregnancy risks were higher and showed statistical significance in these two groups.

“This suggests that for RA and IBD, comorbidities may be a more important factor for adverse outcomes than the underlying autoimmune disease,” senior author Jennifer Hadlock, MD, an associate professor and director of medical data science at the Institute for Systems Biology in Seattle, Washington, said in a video accompanying a press release.

Overall, the analysis found that women with IMIDs were approximately two to three times more likely to have chronic comorbidities than the control group.

Like previous studies, there was a strong association between SLE and APS and poor pregnancy outcomes, even after controlling for confounding factors. Patients with SpA had a 50% increased risk for PTB, while those with SLE and APS had more than a twofold higher risk. Patients with SLE were 90% more likely than comparators to deliver babies with an SGA condition, while RA patients had a 30% higher risk. SLE was the only condition with an increased risk for LBW (relative risk, 3.5). IBD, RA, PsA, SpA, SLE, APS, and SjS were all associated with a higher likelihood of delivery via cesarean section.

“The findings of this study reveal that the associations between IMIDs and adverse pregnancy outcomes are influenced by the specific type of IMIDs and the presence of comorbidities,” the authors wrote.
 

A Large Study, But How Representative Is It?

Asked to comment on the study, Catherine Sims, MD, a rheumatologist at Duke University Medical Center in Durham, North Carolina, noted that the analysis was much larger than many reproductive rheumatology studies, and “their statistics were phenomenal.”

She agreed that “not all autoimmune diseases are created equal when it comes to pregnancy-associated risks.” However, she added that this study’s patient population may not be totally representative of pregnant people with IMIDs or autoimmune diseases.

“We’re making generalizations about autoimmune diseases based on this demographic of White women who are not taking immunosuppression,” she said.

“We know that race and ethnicity play a huge role in pregnancy outcomes, and Black women have higher maternal and fetal morbidity and mortality, which is likely related to systemic racism and biases in the medical system,” she added. “While the study did control for sociodemographic factors, the population studied is not diverse.”

Only 17% of people with IMID in the cohort were on immunosuppressive medication, which could suggest low disease activity in the study population, Dr. Sims said. If the population generally had well-controlled disease, that could have positioned them for better pregnancy outcomes.

The authors noted that their analysis did not have information on IMID disease activity or severity — one of the limitations of the study.

However, the authors argued that the observed low prescription rate during the study may have increased poor pregnancy outcomes.

“Although this reflects real-world care in the population studied, results from this study may show higher risk than might be achieved with recommended care guidelines,” they wrote.

Ultimately, the authors argued that these findings show how co-occurring health conditions can affect pregnancy outcomes in autoimmune diseases, particularly for RA and IBD.

“There is a need to take comorbidities into consideration for guidelines for patients with inflammatory bowel disease and rheumatoid arthritis and when designing future research to investigate maternal health in patients with IMIDs,” they wrote.

The study was funded by the National Institutes of Health. Dr. Sims declared no relevant financial relationships. Dr. Hadlock has received research funding (paid to the institute) from Pfizer, Novartis, Janssen, Bristol-Myers Squibb, and Gilead.

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

Cases of menstrual disorders, particularly unusually heavy menstrual bleeding, have been reported following RNA vaccination against COVID-19.

In France, this safety signal has been confirmed and added to the product characteristics summaries and vaccine leaflets for mRNA vaccines in October 2022. However, few studies have accurately measured this risk to date.

To address this gap in research, the French scientific interest group in the epidemiology of health products, ANSM-Cnam EPI-PHARE, conducted a study to assess the risk for heavy menstrual bleeding requiring hospitalization after COVID-19 vaccination in France.

“This study provides new evidence supporting the existence of an increased risk for heavy menstrual bleeding following COVID-19 vaccination with mRNA vaccines,” wrote the authors.
 

Study Details

The study included all women aged 15-50 years who were diagnosed with heavy menstrual bleeding in the hospital between May 12, 2021, and August 31, 2022. Participants were identified in the National Health Data System, and the study population totaled 4610 women.

Each participant was randomly matched with as many as 30 women who had not been hospitalized for abnormal genital bleeding and had similar characteristics in terms of age, department of residence, social deprivation index of the commune of residence, and contraceptive method.

Women who had a recent pregnancy, hysterectomy, or coagulation disorder within the specified time frames were excluded.

At the time of the study, 71% of cases and 70% of controls had received at least one dose of the COVID-19 vaccine. Among vaccinated participants, 68% and 66%, respectively, received a vaccination dose (first or second dose). An mRNA vaccine (Comirnaty or Spikevax) was the last vaccine for 99.8% of the population.
 

Increased Risk 

Compared with control women, those hospitalized for heavy menstrual bleeding were more likely to have received their last dose of mRNA vaccine (Comirnaty or Spikevax) in the previous 1-3 months. This association was observed for vaccination doses (odds ratio [OR], 1.20), indicating a 20% increased risk, but it was not found for booster doses (OR, 1.07).

This association was particularly notable for women residing in socially disadvantaged communities (OR, 1.28) and women not using hormonal contraception (OR, 1.28).

The risk did not appear to be increased beyond 3 months after vaccination. Researchers noted that the increased risk may have occurred earlier, considering the likely interval between initial symptoms and hospitalization.

Assuming a causal relationship, the estimated number of cases attributable to vaccination was 8 cases per million vaccinated women, totaling 103 cases among all women aged 15-50 years who were vaccinated in France between May 12, 2021, and August 31, 2022.

As of the study date and in the 3 years before the study, none of the authors had any conflicts of interest with pharmaceutical companies. 
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Cases of menstrual disorders, particularly unusually heavy menstrual bleeding, have been reported following RNA vaccination against COVID-19.

In France, this safety signal has been confirmed and added to the product characteristics summaries and vaccine leaflets for mRNA vaccines in October 2022. However, few studies have accurately measured this risk to date.

To address this gap in research, the French scientific interest group in the epidemiology of health products, ANSM-Cnam EPI-PHARE, conducted a study to assess the risk for heavy menstrual bleeding requiring hospitalization after COVID-19 vaccination in France.

“This study provides new evidence supporting the existence of an increased risk for heavy menstrual bleeding following COVID-19 vaccination with mRNA vaccines,” wrote the authors.
 

Study Details

The study included all women aged 15-50 years who were diagnosed with heavy menstrual bleeding in the hospital between May 12, 2021, and August 31, 2022. Participants were identified in the National Health Data System, and the study population totaled 4610 women.

Each participant was randomly matched with as many as 30 women who had not been hospitalized for abnormal genital bleeding and had similar characteristics in terms of age, department of residence, social deprivation index of the commune of residence, and contraceptive method.

Women who had a recent pregnancy, hysterectomy, or coagulation disorder within the specified time frames were excluded.

At the time of the study, 71% of cases and 70% of controls had received at least one dose of the COVID-19 vaccine. Among vaccinated participants, 68% and 66%, respectively, received a vaccination dose (first or second dose). An mRNA vaccine (Comirnaty or Spikevax) was the last vaccine for 99.8% of the population.
 

Increased Risk 

Compared with control women, those hospitalized for heavy menstrual bleeding were more likely to have received their last dose of mRNA vaccine (Comirnaty or Spikevax) in the previous 1-3 months. This association was observed for vaccination doses (odds ratio [OR], 1.20), indicating a 20% increased risk, but it was not found for booster doses (OR, 1.07).

This association was particularly notable for women residing in socially disadvantaged communities (OR, 1.28) and women not using hormonal contraception (OR, 1.28).

The risk did not appear to be increased beyond 3 months after vaccination. Researchers noted that the increased risk may have occurred earlier, considering the likely interval between initial symptoms and hospitalization.

Assuming a causal relationship, the estimated number of cases attributable to vaccination was 8 cases per million vaccinated women, totaling 103 cases among all women aged 15-50 years who were vaccinated in France between May 12, 2021, and August 31, 2022.

As of the study date and in the 3 years before the study, none of the authors had any conflicts of interest with pharmaceutical companies. 
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Cases of menstrual disorders, particularly unusually heavy menstrual bleeding, have been reported following RNA vaccination against COVID-19.

In France, this safety signal has been confirmed and added to the product characteristics summaries and vaccine leaflets for mRNA vaccines in October 2022. However, few studies have accurately measured this risk to date.

To address this gap in research, the French scientific interest group in the epidemiology of health products, ANSM-Cnam EPI-PHARE, conducted a study to assess the risk for heavy menstrual bleeding requiring hospitalization after COVID-19 vaccination in France.

“This study provides new evidence supporting the existence of an increased risk for heavy menstrual bleeding following COVID-19 vaccination with mRNA vaccines,” wrote the authors.
 

Study Details

The study included all women aged 15-50 years who were diagnosed with heavy menstrual bleeding in the hospital between May 12, 2021, and August 31, 2022. Participants were identified in the National Health Data System, and the study population totaled 4610 women.

Each participant was randomly matched with as many as 30 women who had not been hospitalized for abnormal genital bleeding and had similar characteristics in terms of age, department of residence, social deprivation index of the commune of residence, and contraceptive method.

Women who had a recent pregnancy, hysterectomy, or coagulation disorder within the specified time frames were excluded.

At the time of the study, 71% of cases and 70% of controls had received at least one dose of the COVID-19 vaccine. Among vaccinated participants, 68% and 66%, respectively, received a vaccination dose (first or second dose). An mRNA vaccine (Comirnaty or Spikevax) was the last vaccine for 99.8% of the population.
 

Increased Risk 

Compared with control women, those hospitalized for heavy menstrual bleeding were more likely to have received their last dose of mRNA vaccine (Comirnaty or Spikevax) in the previous 1-3 months. This association was observed for vaccination doses (odds ratio [OR], 1.20), indicating a 20% increased risk, but it was not found for booster doses (OR, 1.07).

This association was particularly notable for women residing in socially disadvantaged communities (OR, 1.28) and women not using hormonal contraception (OR, 1.28).

The risk did not appear to be increased beyond 3 months after vaccination. Researchers noted that the increased risk may have occurred earlier, considering the likely interval between initial symptoms and hospitalization.

Assuming a causal relationship, the estimated number of cases attributable to vaccination was 8 cases per million vaccinated women, totaling 103 cases among all women aged 15-50 years who were vaccinated in France between May 12, 2021, and August 31, 2022.

As of the study date and in the 3 years before the study, none of the authors had any conflicts of interest with pharmaceutical companies. 
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Violence against women by partners is a serious human rights violation and a significant global public health issue. Overall, an estimated 27% of women aged 15-49 years who have been in a relationship have experienced physical or sexual violence (SV) at the hands of a partner. According to 2019 data from the US Department of Justice, SV in the United States occurs every 73 seconds, with child victims every 9 minutes. Lifetime rates of SV are around 17%-18% for women and 3% for men.

The emergency department remains the most common place where patients who have experienced SV seek comprehensive care, including emergency contraception, prophylaxis against sexually transmitted infections, forensic evidence collection for rape cases, and treatment for injuries.

Physical injuries from SV are not always detectable. Studies report variable percentages, ranging from 30%-80% of patients with traumatic SV injuries. Evidence regarding their severity is conflicting. Genital injuries are more common in assaults by acquaintances and in victims not using hormonal contraceptives.

The presence or absence of anogenital injuries following SV is a factor that can influence both victims’ willingness to report a crime and the judicial decision-making process regarding accusations and convictions. 

Rape Myths

The mythology of rape has been under discussion for more than 50 years, encompassing concerns that rape myths reinforce ideas about what does and does not constitute SV and who is a credible victim.

Rape myths, classically defined in the 1980s, are “prejudiced, stereotyped, and false beliefs about rape, rape victims, and rapists,” designed to “deny or minimize perceived harm or blame victims for their victimization.” The concept remains relevant to contemporary societal beliefs and concerns.

A systematic review analyzed elements of rape myths related to victim characteristics and their impact on credibility and blame attribution in the investigative process. Victims who knew the (male) perpetrator and were deemed provocative based on attire were assigned greater blame. In addition, detail and consistency in victims› statements and the presence of physical evidence and injuries increased credibility. However, in certain situations, rape myths may lead to blaming victims who do not fit the “real victim” stereotype, thus resulting in secondary victimization or revictimization.

Anogenital Injuries 

Anogenital injuries can occur in relation to consensual sexual activity (CSA), and SV may not be associated with injuries. Therefore, the presence of anogenital injuries does not “prove” SV nor does their absence exclude rape.

This statement is supported by a systematic review and meta-analysis investigating the prevalence of anogenital injuries in women following SV and CSA, using consistent examination techniques for better forensic evidence evaluation in criminal proceedings.

The following two groups were defined for comparison: SV, indicating any nonconsensual sexual contact with the survivor’s anogenital area, and CSA, representing the same type of sexual contact with participants’ consent.

The outcome measure was the presence of anogenital injury (defined as any genital, anal, or perineal injury detected using described techniques in each study). With no universal definition of genital trauma, the result assessment was dichotomous: The presence or absence of injury.

The systematic search yielded 1401 results, and 10 cohort studies published from 1997 to 2022 met the inclusion criteria. The study participants were 3165 women, with 59% (1874/3165) surviving SV.

Anogenital injuries were found in 48% of women who experienced SV (901/1874) and in 31% of those with CSA (394/1291). Anogenital injuries were significantly more likely in women who had experienced SV, compared with those with CSA (risk ratio, 1.59; P < .001). However, both groups had cases where anogenital injuries were either detected or not.

Some SV survivors had no identified anogenital injuries, and women examined after CSA had detectable anogenital injuries. Subgroup analysis for high-quality studies showed no significant differences between groups. These data support the hypothesis that the presence of anogenital injuries does not prove SV, and the absence of injuries does not disprove it.

Point for Practice

Numerous myths reinforce cultural attitudes toward reporting SV. One myth suggests that physical violence, and thus injuries, are inevitable accompaniments to rape. If the victim does not react physically, it might be argued that it was not really rape, or without physical trauma, one might be less inclined to believe that a rape occurred.

Physicians and healthcare professionals involved in the care and support of SV survivors must explicitly reassure them that the lack of anogenital injury evidence does not diminish the credibility of their account.
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Violence against women by partners is a serious human rights violation and a significant global public health issue. Overall, an estimated 27% of women aged 15-49 years who have been in a relationship have experienced physical or sexual violence (SV) at the hands of a partner. According to 2019 data from the US Department of Justice, SV in the United States occurs every 73 seconds, with child victims every 9 minutes. Lifetime rates of SV are around 17%-18% for women and 3% for men.

The emergency department remains the most common place where patients who have experienced SV seek comprehensive care, including emergency contraception, prophylaxis against sexually transmitted infections, forensic evidence collection for rape cases, and treatment for injuries.

Physical injuries from SV are not always detectable. Studies report variable percentages, ranging from 30%-80% of patients with traumatic SV injuries. Evidence regarding their severity is conflicting. Genital injuries are more common in assaults by acquaintances and in victims not using hormonal contraceptives.

The presence or absence of anogenital injuries following SV is a factor that can influence both victims’ willingness to report a crime and the judicial decision-making process regarding accusations and convictions. 

Rape Myths

The mythology of rape has been under discussion for more than 50 years, encompassing concerns that rape myths reinforce ideas about what does and does not constitute SV and who is a credible victim.

Rape myths, classically defined in the 1980s, are “prejudiced, stereotyped, and false beliefs about rape, rape victims, and rapists,” designed to “deny or minimize perceived harm or blame victims for their victimization.” The concept remains relevant to contemporary societal beliefs and concerns.

A systematic review analyzed elements of rape myths related to victim characteristics and their impact on credibility and blame attribution in the investigative process. Victims who knew the (male) perpetrator and were deemed provocative based on attire were assigned greater blame. In addition, detail and consistency in victims› statements and the presence of physical evidence and injuries increased credibility. However, in certain situations, rape myths may lead to blaming victims who do not fit the “real victim” stereotype, thus resulting in secondary victimization or revictimization.

Anogenital Injuries 

Anogenital injuries can occur in relation to consensual sexual activity (CSA), and SV may not be associated with injuries. Therefore, the presence of anogenital injuries does not “prove” SV nor does their absence exclude rape.

This statement is supported by a systematic review and meta-analysis investigating the prevalence of anogenital injuries in women following SV and CSA, using consistent examination techniques for better forensic evidence evaluation in criminal proceedings.

The following two groups were defined for comparison: SV, indicating any nonconsensual sexual contact with the survivor’s anogenital area, and CSA, representing the same type of sexual contact with participants’ consent.

The outcome measure was the presence of anogenital injury (defined as any genital, anal, or perineal injury detected using described techniques in each study). With no universal definition of genital trauma, the result assessment was dichotomous: The presence or absence of injury.

The systematic search yielded 1401 results, and 10 cohort studies published from 1997 to 2022 met the inclusion criteria. The study participants were 3165 women, with 59% (1874/3165) surviving SV.

Anogenital injuries were found in 48% of women who experienced SV (901/1874) and in 31% of those with CSA (394/1291). Anogenital injuries were significantly more likely in women who had experienced SV, compared with those with CSA (risk ratio, 1.59; P < .001). However, both groups had cases where anogenital injuries were either detected or not.

Some SV survivors had no identified anogenital injuries, and women examined after CSA had detectable anogenital injuries. Subgroup analysis for high-quality studies showed no significant differences between groups. These data support the hypothesis that the presence of anogenital injuries does not prove SV, and the absence of injuries does not disprove it.

Point for Practice

Numerous myths reinforce cultural attitudes toward reporting SV. One myth suggests that physical violence, and thus injuries, are inevitable accompaniments to rape. If the victim does not react physically, it might be argued that it was not really rape, or without physical trauma, one might be less inclined to believe that a rape occurred.

Physicians and healthcare professionals involved in the care and support of SV survivors must explicitly reassure them that the lack of anogenital injury evidence does not diminish the credibility of their account.
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Violence against women by partners is a serious human rights violation and a significant global public health issue. Overall, an estimated 27% of women aged 15-49 years who have been in a relationship have experienced physical or sexual violence (SV) at the hands of a partner. According to 2019 data from the US Department of Justice, SV in the United States occurs every 73 seconds, with child victims every 9 minutes. Lifetime rates of SV are around 17%-18% for women and 3% for men.

The emergency department remains the most common place where patients who have experienced SV seek comprehensive care, including emergency contraception, prophylaxis against sexually transmitted infections, forensic evidence collection for rape cases, and treatment for injuries.

Physical injuries from SV are not always detectable. Studies report variable percentages, ranging from 30%-80% of patients with traumatic SV injuries. Evidence regarding their severity is conflicting. Genital injuries are more common in assaults by acquaintances and in victims not using hormonal contraceptives.

The presence or absence of anogenital injuries following SV is a factor that can influence both victims’ willingness to report a crime and the judicial decision-making process regarding accusations and convictions. 

Rape Myths

The mythology of rape has been under discussion for more than 50 years, encompassing concerns that rape myths reinforce ideas about what does and does not constitute SV and who is a credible victim.

Rape myths, classically defined in the 1980s, are “prejudiced, stereotyped, and false beliefs about rape, rape victims, and rapists,” designed to “deny or minimize perceived harm or blame victims for their victimization.” The concept remains relevant to contemporary societal beliefs and concerns.

A systematic review analyzed elements of rape myths related to victim characteristics and their impact on credibility and blame attribution in the investigative process. Victims who knew the (male) perpetrator and were deemed provocative based on attire were assigned greater blame. In addition, detail and consistency in victims› statements and the presence of physical evidence and injuries increased credibility. However, in certain situations, rape myths may lead to blaming victims who do not fit the “real victim” stereotype, thus resulting in secondary victimization or revictimization.

Anogenital Injuries 

Anogenital injuries can occur in relation to consensual sexual activity (CSA), and SV may not be associated with injuries. Therefore, the presence of anogenital injuries does not “prove” SV nor does their absence exclude rape.

This statement is supported by a systematic review and meta-analysis investigating the prevalence of anogenital injuries in women following SV and CSA, using consistent examination techniques for better forensic evidence evaluation in criminal proceedings.

The following two groups were defined for comparison: SV, indicating any nonconsensual sexual contact with the survivor’s anogenital area, and CSA, representing the same type of sexual contact with participants’ consent.

The outcome measure was the presence of anogenital injury (defined as any genital, anal, or perineal injury detected using described techniques in each study). With no universal definition of genital trauma, the result assessment was dichotomous: The presence or absence of injury.

The systematic search yielded 1401 results, and 10 cohort studies published from 1997 to 2022 met the inclusion criteria. The study participants were 3165 women, with 59% (1874/3165) surviving SV.

Anogenital injuries were found in 48% of women who experienced SV (901/1874) and in 31% of those with CSA (394/1291). Anogenital injuries were significantly more likely in women who had experienced SV, compared with those with CSA (risk ratio, 1.59; P < .001). However, both groups had cases where anogenital injuries were either detected or not.

Some SV survivors had no identified anogenital injuries, and women examined after CSA had detectable anogenital injuries. Subgroup analysis for high-quality studies showed no significant differences between groups. These data support the hypothesis that the presence of anogenital injuries does not prove SV, and the absence of injuries does not disprove it.

Point for Practice

Numerous myths reinforce cultural attitudes toward reporting SV. One myth suggests that physical violence, and thus injuries, are inevitable accompaniments to rape. If the victim does not react physically, it might be argued that it was not really rape, or without physical trauma, one might be less inclined to believe that a rape occurred.

Physicians and healthcare professionals involved in the care and support of SV survivors must explicitly reassure them that the lack of anogenital injury evidence does not diminish the credibility of their account.
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

TOPLINE:

People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.

METHODOLOGY:

• Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
• A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
• Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
• Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.

TAKEAWAY:

• Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
• MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
• Those in the PCOS group were more likely to be White and have diabetes than those in the control group.

IN PRACTICE:

“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.

SOURCE:

Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.

LIMITATIONS:

PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.

DISCLOSURES:

The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.

A version of this article appeared on Medscape.com.

TOPLINE:

People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.

METHODOLOGY:

• Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
• A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
• Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
• Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.

TAKEAWAY:

• Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
• MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
• Those in the PCOS group were more likely to be White and have diabetes than those in the control group.

IN PRACTICE:

“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.

SOURCE:

Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.

LIMITATIONS:

PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.

DISCLOSURES:

The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.

A version of this article appeared on Medscape.com.

TOPLINE:

People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.

METHODOLOGY:

• Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
• A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
• Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
• Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.

TAKEAWAY:

• Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
• MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
• Those in the PCOS group were more likely to be White and have diabetes than those in the control group.

IN PRACTICE:

“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.

SOURCE:

Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.

LIMITATIONS:

PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.

DISCLOSURES:

The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.

METHODOLOGY:

• Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
• This is the first investigation of whether cold water swimming has an impact on these symptoms.
• Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
• Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.

TAKEAWAY:

• Researchers found that cold water swimming had multiple beneficial effects on both menstrual and perimenopausal symptoms.
• Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
• Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
• Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.

IN PRACTICE:

“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.

SOURCE:

The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.

LIMITATIONS:

This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.

DISCLOSURES:

Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.

METHODOLOGY:

• Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
• This is the first investigation of whether cold water swimming has an impact on these symptoms.
• Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
• Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.

TAKEAWAY:

• Researchers found that cold water swimming had multiple beneficial effects on both menstrual and perimenopausal symptoms.
• Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
• Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
• Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.

IN PRACTICE:

“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.

SOURCE:

The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.

LIMITATIONS:

This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.

DISCLOSURES:

Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with menstrual or perimenopausal symptoms can relieve common physical and psychological issues through cold water swimming, a new study finds.

METHODOLOGY:

• Symptoms of menstrual cycles and perimenopause vary widely but frequently include mood swings, anxiety, depression, fatigue, hot flashes, and sleep disturbances.
• This is the first investigation of whether cold water swimming has an impact on these symptoms.
• Researchers conducted a 42-question online survey of 1114 women who were regularly swam in cold water. More than two-thirds of respondents (68.1%) were between 45 and 59 years of age.
• Some of the data included responses by women who were perimenopausal but still had menstrual symptoms.

TAKEAWAY:

• Researchers found that cold water swimming had multiple beneficial effects on both menstrual and perimenopausal symptoms.
• Women who swam more frequently and for longer reported more beneficial effects than women who swam less often or for less time per swim.
• Reduction of psychological and vasomotor symptoms were most often cited by cold-water swimmers.
• Perimenopausal women who swam regularly in winter and summer saw greater reduction in anxiety and hot flashes than did those who swam in the other seasons.

IN PRACTICE:

“Teaching women to swim safely and encouraging them to swim regularly may have a benefit on the debilitating symptoms associated with the perimenopause,” the authors wrote.

SOURCE:

The study was conducted by researchers from University College, London, and published online in Post Reproductive Health. The corresponding author is Joyce Harper, PhD, professor of reproductive science at EGA Institute for Women’s Health, University College London, England.

LIMITATIONS:

This was an observational study, with no control group. The underlying cause of improved psychological symptoms of perimenopause were not fully evaluated owing to unaccounted multiple variables. Use of an online survey may introduce sampling bias and not align with the population of all menstruating or perimenopausal women. Participants were primarily White and highly educated.

DISCLOSURES:

Dr. Harper disclosed giving paid talks on menopause to businesses and at conferences.

A version of this article appeared on Medscape.com.

New evidence suggests that nausea and vomiting of pregnancy (NVP) is tied to elevated levels of the fetal placenta–derived hormone GDF15, and targeting the hormone prophylactically may reduce this common gestational condition.

This protein acts on the brainstem to cause emesis, and, significantly, a mother’s prior exposure to it determines the degree of NVP severity she will experience, according to international researchers including Marlena Fejzo, PhD, a clinical assistant professor of population and public Health at Keck School of Medicine, University of Southern California, Los Angeles.

“GDF15 is at the mechanistic heart of NVP and HG [hyperemesis gravidarum],” Dr. Fejzo and colleagues wrote in Nature, pointing to the need for preventive and therapeutic strategies.

Courtesy HER Foundation

“My previous research showed an association between variation in the GDF15 gene and nausea and vomiting of pregnancy and HG, and this study takes it one step further by elucidating the mechanism. It confirms that the nausea and vomiting (N/V) hormone GDF15 is a major cause of NVP and HG,” Dr. Fejzo said.

The etiology of NVP remains poorly understood although it affects up to 80% of pregnancies. In the US, its severe form, HG, is the leading cause of hospitalization in early pregnancy and the second-leading reason for pregnancy hospitalization overall.

The immunoassay-based study showed that the majority of GDF15 in maternal blood during pregnancy comes from the fetal part of the placenta, and confirms previous studies reporting higher levels in pregnancies with more severe NVP, said Dr. Fejzo, who is who is a board member of the Hyperemesis Education and Research Foundation.

“However, what was really fascinating and surprising is that prior to pregnancy the women who have more severe NVP symptoms actually have lower levels of the hormone.”

Although the gene variant linked to HG was previously associated with higher circulating levels in maternal blood, counterintuitively, this new research showed that women with abnormally high levels prior to pregnancy have either no or very little NVP, said Dr. Fejzo. “That suggests that in humans higher levels may lead to a desensitization to the high levels of the hormone in pregnancy. Then we also proved that desensitization can occur in a mouse model.” 

According to Erin Higgins, MD, a clinical assistant professor of obgyn and reproductive biology at the Cleveland Clinic, Cleveland, Ohio, who was not involved in the study, “This is an exciting finding that may help us to better target treatment of N/V in pregnancy. Factors for NVP have been identified, but to my knowledge there has not been a clear etiology.”

Courtesy Cleveland Clinic

Dr. Higgins cautioned, however, that the GDF15 gene seems important in normal placentation, “so it’s not as simple as blocking the gene or its receptor.” But since preconception exposure to GDF15 might decrease nausea and vomiting once a woman is pregnant, prophylactic treatment may be possible, and metformin has been suggested as a possibility, she said.

The study findings emerged from immunoassays on maternal blood samples collected at about 15 weeks (first trimester and early second trimester), from women with NVP (n = 168) or seen at a hospital for HG (n = 57). Results were compared with those from controls having similar characteristics but no significant symptoms.

Interestingly, GDF15 is also associated with cachexia, a condition similar to HG and characterized by loss of appetite and weight loss, Dr. Fejzo noted. “The hormone can be produced by malignant tumors at levels similar to those seen in pregnancy, and symptoms can be reduced by blocking GDF15 or its receptor, GFRAL. Clinical trials are already underway in cancer patients to test this.”

She is seeking funding to test the impact of increasing GDF15 levels prior to pregnancy in patients who previously experienced HG. “I am confident that desensitizing patients by increasing GDF15 prior to pregnancy and by lowering GDF15 levels during pregnancy will work. But we need to make sure we do safety studies and get the dosing and duration right, and that will take some time.”

Desensitization will need testing first in HG, where the risk for adverse maternal and fetal outcomes is high, so the benefit will outweigh any possible risk of testing medication in pregnancy, she continued. “It will take some time before we get to patients with normal NVP, but I do believe eventually the new findings will result in game-changing therapeutics for the condition.”

Dr. Higgins added, “Even if this isn’t the golden ticket, researchers and clinicians are working toward improvements in the treatment of NVP. We’ve already come a long way in recent years with the development of treatment algorithms and the advent of doxylamine/pyridoxine.”

This study was supported primarily by the Medical Research Council UK and National Institute for Health and Care Research UK, with additional support from various research funding organizations, including Novo Nordisk Foundation.

Dr. Fejzo is a paid consultant for Materna Biosciences and NGM Biopharmaceuticals, and a board member and science adviser for the Hyperemesis Education and Research Foundation.

Numerous study co-authors disclosed financial relationships with private-sector companies, including employment and patent ownership.

Dr. Higgins disclosed no competing interests relevant to her comments but is an instructor for Organon.

New evidence suggests that nausea and vomiting of pregnancy (NVP) is tied to elevated levels of the fetal placenta–derived hormone GDF15, and targeting the hormone prophylactically may reduce this common gestational condition.

This protein acts on the brainstem to cause emesis, and, significantly, a mother’s prior exposure to it determines the degree of NVP severity she will experience, according to international researchers including Marlena Fejzo, PhD, a clinical assistant professor of population and public Health at Keck School of Medicine, University of Southern California, Los Angeles.

“GDF15 is at the mechanistic heart of NVP and HG [hyperemesis gravidarum],” Dr. Fejzo and colleagues wrote in Nature, pointing to the need for preventive and therapeutic strategies.

Courtesy HER Foundation

“My previous research showed an association between variation in the GDF15 gene and nausea and vomiting of pregnancy and HG, and this study takes it one step further by elucidating the mechanism. It confirms that the nausea and vomiting (N/V) hormone GDF15 is a major cause of NVP and HG,” Dr. Fejzo said.

The etiology of NVP remains poorly understood although it affects up to 80% of pregnancies. In the US, its severe form, HG, is the leading cause of hospitalization in early pregnancy and the second-leading reason for pregnancy hospitalization overall.

The immunoassay-based study showed that the majority of GDF15 in maternal blood during pregnancy comes from the fetal part of the placenta, and confirms previous studies reporting higher levels in pregnancies with more severe NVP, said Dr. Fejzo, who is who is a board member of the Hyperemesis Education and Research Foundation.

“However, what was really fascinating and surprising is that prior to pregnancy the women who have more severe NVP symptoms actually have lower levels of the hormone.”

Although the gene variant linked to HG was previously associated with higher circulating levels in maternal blood, counterintuitively, this new research showed that women with abnormally high levels prior to pregnancy have either no or very little NVP, said Dr. Fejzo. “That suggests that in humans higher levels may lead to a desensitization to the high levels of the hormone in pregnancy. Then we also proved that desensitization can occur in a mouse model.” 

According to Erin Higgins, MD, a clinical assistant professor of obgyn and reproductive biology at the Cleveland Clinic, Cleveland, Ohio, who was not involved in the study, “This is an exciting finding that may help us to better target treatment of N/V in pregnancy. Factors for NVP have been identified, but to my knowledge there has not been a clear etiology.”

Courtesy Cleveland Clinic

Dr. Higgins cautioned, however, that the GDF15 gene seems important in normal placentation, “so it’s not as simple as blocking the gene or its receptor.” But since preconception exposure to GDF15 might decrease nausea and vomiting once a woman is pregnant, prophylactic treatment may be possible, and metformin has been suggested as a possibility, she said.

The study findings emerged from immunoassays on maternal blood samples collected at about 15 weeks (first trimester and early second trimester), from women with NVP (n = 168) or seen at a hospital for HG (n = 57). Results were compared with those from controls having similar characteristics but no significant symptoms.

Interestingly, GDF15 is also associated with cachexia, a condition similar to HG and characterized by loss of appetite and weight loss, Dr. Fejzo noted. “The hormone can be produced by malignant tumors at levels similar to those seen in pregnancy, and symptoms can be reduced by blocking GDF15 or its receptor, GFRAL. Clinical trials are already underway in cancer patients to test this.”

She is seeking funding to test the impact of increasing GDF15 levels prior to pregnancy in patients who previously experienced HG. “I am confident that desensitizing patients by increasing GDF15 prior to pregnancy and by lowering GDF15 levels during pregnancy will work. But we need to make sure we do safety studies and get the dosing and duration right, and that will take some time.”

Desensitization will need testing first in HG, where the risk for adverse maternal and fetal outcomes is high, so the benefit will outweigh any possible risk of testing medication in pregnancy, she continued. “It will take some time before we get to patients with normal NVP, but I do believe eventually the new findings will result in game-changing therapeutics for the condition.”

Dr. Higgins added, “Even if this isn’t the golden ticket, researchers and clinicians are working toward improvements in the treatment of NVP. We’ve already come a long way in recent years with the development of treatment algorithms and the advent of doxylamine/pyridoxine.”

This study was supported primarily by the Medical Research Council UK and National Institute for Health and Care Research UK, with additional support from various research funding organizations, including Novo Nordisk Foundation.

Dr. Fejzo is a paid consultant for Materna Biosciences and NGM Biopharmaceuticals, and a board member and science adviser for the Hyperemesis Education and Research Foundation.

Numerous study co-authors disclosed financial relationships with private-sector companies, including employment and patent ownership.

Dr. Higgins disclosed no competing interests relevant to her comments but is an instructor for Organon.

New evidence suggests that nausea and vomiting of pregnancy (NVP) is tied to elevated levels of the fetal placenta–derived hormone GDF15, and targeting the hormone prophylactically may reduce this common gestational condition.

This protein acts on the brainstem to cause emesis, and, significantly, a mother’s prior exposure to it determines the degree of NVP severity she will experience, according to international researchers including Marlena Fejzo, PhD, a clinical assistant professor of population and public Health at Keck School of Medicine, University of Southern California, Los Angeles.

“GDF15 is at the mechanistic heart of NVP and HG [hyperemesis gravidarum],” Dr. Fejzo and colleagues wrote in Nature, pointing to the need for preventive and therapeutic strategies.

Courtesy HER Foundation

“My previous research showed an association between variation in the GDF15 gene and nausea and vomiting of pregnancy and HG, and this study takes it one step further by elucidating the mechanism. It confirms that the nausea and vomiting (N/V) hormone GDF15 is a major cause of NVP and HG,” Dr. Fejzo said.

The etiology of NVP remains poorly understood although it affects up to 80% of pregnancies. In the US, its severe form, HG, is the leading cause of hospitalization in early pregnancy and the second-leading reason for pregnancy hospitalization overall.

The immunoassay-based study showed that the majority of GDF15 in maternal blood during pregnancy comes from the fetal part of the placenta, and confirms previous studies reporting higher levels in pregnancies with more severe NVP, said Dr. Fejzo, who is who is a board member of the Hyperemesis Education and Research Foundation.

“However, what was really fascinating and surprising is that prior to pregnancy the women who have more severe NVP symptoms actually have lower levels of the hormone.”

Although the gene variant linked to HG was previously associated with higher circulating levels in maternal blood, counterintuitively, this new research showed that women with abnormally high levels prior to pregnancy have either no or very little NVP, said Dr. Fejzo. “That suggests that in humans higher levels may lead to a desensitization to the high levels of the hormone in pregnancy. Then we also proved that desensitization can occur in a mouse model.” 

According to Erin Higgins, MD, a clinical assistant professor of obgyn and reproductive biology at the Cleveland Clinic, Cleveland, Ohio, who was not involved in the study, “This is an exciting finding that may help us to better target treatment of N/V in pregnancy. Factors for NVP have been identified, but to my knowledge there has not been a clear etiology.”

Courtesy Cleveland Clinic

Dr. Higgins cautioned, however, that the GDF15 gene seems important in normal placentation, “so it’s not as simple as blocking the gene or its receptor.” But since preconception exposure to GDF15 might decrease nausea and vomiting once a woman is pregnant, prophylactic treatment may be possible, and metformin has been suggested as a possibility, she said.

The study findings emerged from immunoassays on maternal blood samples collected at about 15 weeks (first trimester and early second trimester), from women with NVP (n = 168) or seen at a hospital for HG (n = 57). Results were compared with those from controls having similar characteristics but no significant symptoms.

Interestingly, GDF15 is also associated with cachexia, a condition similar to HG and characterized by loss of appetite and weight loss, Dr. Fejzo noted. “The hormone can be produced by malignant tumors at levels similar to those seen in pregnancy, and symptoms can be reduced by blocking GDF15 or its receptor, GFRAL. Clinical trials are already underway in cancer patients to test this.”

She is seeking funding to test the impact of increasing GDF15 levels prior to pregnancy in patients who previously experienced HG. “I am confident that desensitizing patients by increasing GDF15 prior to pregnancy and by lowering GDF15 levels during pregnancy will work. But we need to make sure we do safety studies and get the dosing and duration right, and that will take some time.”

Desensitization will need testing first in HG, where the risk for adverse maternal and fetal outcomes is high, so the benefit will outweigh any possible risk of testing medication in pregnancy, she continued. “It will take some time before we get to patients with normal NVP, but I do believe eventually the new findings will result in game-changing therapeutics for the condition.”

Dr. Higgins added, “Even if this isn’t the golden ticket, researchers and clinicians are working toward improvements in the treatment of NVP. We’ve already come a long way in recent years with the development of treatment algorithms and the advent of doxylamine/pyridoxine.”

This study was supported primarily by the Medical Research Council UK and National Institute for Health and Care Research UK, with additional support from various research funding organizations, including Novo Nordisk Foundation.

Dr. Fejzo is a paid consultant for Materna Biosciences and NGM Biopharmaceuticals, and a board member and science adviser for the Hyperemesis Education and Research Foundation.

Numerous study co-authors disclosed financial relationships with private-sector companies, including employment and patent ownership.

Dr. Higgins disclosed no competing interests relevant to her comments but is an instructor for Organon.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

Symptoms of anxiety and depression increased in adults living in trigger states that immediately banned abortions after the US Supreme Court Dobbs decision overturned Roe v. Wade, which revoked a woman’s constitutional right to an abortion, new research shows.

This could be due to a variety of factors, investigators led by Benjamin Thornburg, Johns Hopkins Bloomberg School of Public Health, Baltimore, noted. These include fear about the imminent risk of being denied an abortion, uncertainty around future limitations on abortion and other related rights such as contraception, worry over the ability to receive lifesaving medical care during pregnancy, and a general sense of violation and powerlessness related to loss of the right to reproductive autonomy.

The study was published online on January 23, 2024, in JAMA. 
 

Mental Health Harm

In June 2022, the US Supreme Court overturned Roe vs Wade, removing federal protections for abortion rights. Thirteen states had “trigger laws” that immediately banned or severely restricted abortion — raising concerns this could negatively affect mental health.

The researchers used data from the Household Pulse Survey to estimate changes in anxiety and depression symptoms after vs before the Dobbs decision in nearly 160,000 adults living in 13 states with trigger laws compared with roughly 559,000 adults living in 37 states without trigger laws.

The mean age of respondents was 48 years, and 51% were women. Anxiety and depression symptoms were measured via the Patient Health Questionnaire-4 (PHQ-4). 

In trigger states, the mean PHQ-4 score at baseline (before Dobbs) was 3.51 (out of 12) and increased to 3.81 after the Dobbs decision. In nontrigger states, the mean PHQ-4 score at baseline was 3.31 and increased to 3.49 after Dobbs.

Living in a trigger state was associated with a small but statistically significant worsening (0.11-point; P < .001) in anxiety/depression symptoms following the Dobbs decision vs living in a nontrigger state, the investigators report.

Women aged 18-45 years faced greater worsening of anxiety and depression symptoms following Dobbs in trigger vs nontrigger states, whereas men of a similar age experienced minimal or negligible changes. 
 

Implications for Care 

In an accompanying editorial, Julie Steinberg, PhD, with University of Maryland in College Park, notes the study results provide “emerging evidence that at an individual level taking away reproductive autonomy (by not having legal access to an abortion) may increase symptoms of anxiety and depression in all people and particularly females of reproductive age.”

These results add to findings from two other studies that examined abortion restrictions and mental health outcomes. Both found that limiting access to abortion was associated with more mental health symptoms among females of reproductive age than among others,” Dr. Steinberg pointed out.

“Together these findings highlight the need for clinicians who practice in states where abortion is banned to be aware that female patients of reproductive age may be experiencing significantly more distress than before the Dobbs decision,” Dr. Steinberg added. 

The study received no specific funding. The authors had no relevant conflicts of interest. Dr. Steinberg reported serving as a paid expert scientist on abortion and mental health in seven cases challenging abortion policies.

A version of this article appeared on Medscape.com.

Symptoms of anxiety and depression increased in adults living in trigger states that immediately banned abortions after the US Supreme Court Dobbs decision overturned Roe v. Wade, which revoked a woman’s constitutional right to an abortion, new research shows.

This could be due to a variety of factors, investigators led by Benjamin Thornburg, Johns Hopkins Bloomberg School of Public Health, Baltimore, noted. These include fear about the imminent risk of being denied an abortion, uncertainty around future limitations on abortion and other related rights such as contraception, worry over the ability to receive lifesaving medical care during pregnancy, and a general sense of violation and powerlessness related to loss of the right to reproductive autonomy.

The study was published online on January 23, 2024, in JAMA. 
 

Mental Health Harm

In June 2022, the US Supreme Court overturned Roe vs Wade, removing federal protections for abortion rights. Thirteen states had “trigger laws” that immediately banned or severely restricted abortion — raising concerns this could negatively affect mental health.

The researchers used data from the Household Pulse Survey to estimate changes in anxiety and depression symptoms after vs before the Dobbs decision in nearly 160,000 adults living in 13 states with trigger laws compared with roughly 559,000 adults living in 37 states without trigger laws.

The mean age of respondents was 48 years, and 51% were women. Anxiety and depression symptoms were measured via the Patient Health Questionnaire-4 (PHQ-4). 

In trigger states, the mean PHQ-4 score at baseline (before Dobbs) was 3.51 (out of 12) and increased to 3.81 after the Dobbs decision. In nontrigger states, the mean PHQ-4 score at baseline was 3.31 and increased to 3.49 after Dobbs.

Living in a trigger state was associated with a small but statistically significant worsening (0.11-point; P < .001) in anxiety/depression symptoms following the Dobbs decision vs living in a nontrigger state, the investigators report.

Women aged 18-45 years faced greater worsening of anxiety and depression symptoms following Dobbs in trigger vs nontrigger states, whereas men of a similar age experienced minimal or negligible changes. 
 

Implications for Care 

In an accompanying editorial, Julie Steinberg, PhD, with University of Maryland in College Park, notes the study results provide “emerging evidence that at an individual level taking away reproductive autonomy (by not having legal access to an abortion) may increase symptoms of anxiety and depression in all people and particularly females of reproductive age.”

These results add to findings from two other studies that examined abortion restrictions and mental health outcomes. Both found that limiting access to abortion was associated with more mental health symptoms among females of reproductive age than among others,” Dr. Steinberg pointed out.

“Together these findings highlight the need for clinicians who practice in states where abortion is banned to be aware that female patients of reproductive age may be experiencing significantly more distress than before the Dobbs decision,” Dr. Steinberg added. 

The study received no specific funding. The authors had no relevant conflicts of interest. Dr. Steinberg reported serving as a paid expert scientist on abortion and mental health in seven cases challenging abortion policies.

A version of this article appeared on Medscape.com.

Symptoms of anxiety and depression increased in adults living in trigger states that immediately banned abortions after the US Supreme Court Dobbs decision overturned Roe v. Wade, which revoked a woman’s constitutional right to an abortion, new research shows.

This could be due to a variety of factors, investigators led by Benjamin Thornburg, Johns Hopkins Bloomberg School of Public Health, Baltimore, noted. These include fear about the imminent risk of being denied an abortion, uncertainty around future limitations on abortion and other related rights such as contraception, worry over the ability to receive lifesaving medical care during pregnancy, and a general sense of violation and powerlessness related to loss of the right to reproductive autonomy.

The study was published online on January 23, 2024, in JAMA. 
 

Mental Health Harm

In June 2022, the US Supreme Court overturned Roe vs Wade, removing federal protections for abortion rights. Thirteen states had “trigger laws” that immediately banned or severely restricted abortion — raising concerns this could negatively affect mental health.

The researchers used data from the Household Pulse Survey to estimate changes in anxiety and depression symptoms after vs before the Dobbs decision in nearly 160,000 adults living in 13 states with trigger laws compared with roughly 559,000 adults living in 37 states without trigger laws.

The mean age of respondents was 48 years, and 51% were women. Anxiety and depression symptoms were measured via the Patient Health Questionnaire-4 (PHQ-4). 

In trigger states, the mean PHQ-4 score at baseline (before Dobbs) was 3.51 (out of 12) and increased to 3.81 after the Dobbs decision. In nontrigger states, the mean PHQ-4 score at baseline was 3.31 and increased to 3.49 after Dobbs.

Living in a trigger state was associated with a small but statistically significant worsening (0.11-point; P < .001) in anxiety/depression symptoms following the Dobbs decision vs living in a nontrigger state, the investigators report.

Women aged 18-45 years faced greater worsening of anxiety and depression symptoms following Dobbs in trigger vs nontrigger states, whereas men of a similar age experienced minimal or negligible changes. 
 

Implications for Care 

In an accompanying editorial, Julie Steinberg, PhD, with University of Maryland in College Park, notes the study results provide “emerging evidence that at an individual level taking away reproductive autonomy (by not having legal access to an abortion) may increase symptoms of anxiety and depression in all people and particularly females of reproductive age.”

These results add to findings from two other studies that examined abortion restrictions and mental health outcomes. Both found that limiting access to abortion was associated with more mental health symptoms among females of reproductive age than among others,” Dr. Steinberg pointed out.

“Together these findings highlight the need for clinicians who practice in states where abortion is banned to be aware that female patients of reproductive age may be experiencing significantly more distress than before the Dobbs decision,” Dr. Steinberg added. 

The study received no specific funding. The authors had no relevant conflicts of interest. Dr. Steinberg reported serving as a paid expert scientist on abortion and mental health in seven cases challenging abortion policies.

A version of this article appeared on Medscape.com.