Women's Health

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.

BUDAPEST, Hungary — A single dose of intravenous esketamine during delivery or cesarean section appears to reduce the risk for postpartum depression (PPD) by more than 50% in the first 6 weeks, a new meta-analysis suggested. However, the long-term safety and efficacy of the drug are still unclear.

Study investigator Angelina Kozhokar, MD, Department of Medicine, Universitat Internacional de Catalunya, Barcelona, Sant Cugat del Valles, Spain, told this news organization she was “surprised” by the size of the PPD risk reduction associated with the drug.

However, she added, “it’s important to consider that preliminary studies on a lot of medications used for postpartum depression have also shown very big effect sizes.”

Dr. Kozhokar believes that as more studies examining esketamine for PPD are conducted, “we will see more definitive effect sizes, and the safety profile for this new treatment” will become clearer.

The findings were presented at the European Psychiatric Association (EPA) Congress.
 

Significant Reduction

As previously reported by this news organization, intranasal esketamine (Spravato, Janssen) was shown to be superior to extended-release quetiapine (Seroquel, AstraZeneca), an atypical antipsychotic, for treatment-resistant depression.

With up to 13% of women experiencing PPD in the perinatal period, the researchers sought to examine the impact of esketamine administered prophylactically during labor or cesarean section on the incidence of the disorder.

They searched the PubMed, Scopus, and Google Scholar databases for randomized controlled trials examining the efficacy of esketamine and screened for PPD using the Edinburgh Postpartum Depression Scale (EPDS).

While the intranasal spray is the only form of esketamine approved by the US Food and Drug Administration, an injectable solution is also available. The researchers identified seven eligible trials that included a total of 1287 women. Of these participants, 635 (49.3%) received esketamine. Esketamine was delivered as either patient-controlled intravenous analgesia or a single intravenous dose during delivery or cesarean section.

Across the seven trials, esketamine was associated with a significant reduction in PPD at 1 week after delivery at a risk ratio vs placebo of 0.459 (P < .05). At 6 weeks, the reduction in PPD incidence was maintained, at a risk ratio of 0.470 (P < .01).

However, Dr. Kozhokar pointed out that the EPDS is a subjective measure of PPD, and the studies used different cutoff scores for depression, ranging from 9 to 13 points.
 

Unanswered Questions

She also cautioned that the adverse effects of esketamine on maternal and neonatal health need to be assessed, as well as the long-term cost/benefit ratio of prophylactic treatment.

All seven studies included in the meta-analysis were conducted in China, which limits the generalizability of the findings.

“I suppose they were quicker to get to the topic than the rest of the world,” Dr. Kozhokar said, while also suggesting that, potentially, “we are more regulated here in Europe.”

She pointed out that there is “an important safety concern about the use of medications such as ketamine and esketamine” in terms of the potential for addiction and the effect on babies over the long term, which is currently unknown.

Session chair Linda Rubene, MD, a psychiatrist in the Department of Psychiatry and Narcology at Riga Stradinš University, Riga, Latvia, welcomed the study.

“If we had more options to treat postpartum depression and to treat depression during pregnancy, it would be a great improvement,” she said.

However, she noted, because there are no long-term outcome data for esketamine in PPD, more study is needed. It is possible, said Dr. Rubene, that esketamine may not work for all women.

The investigators and Dr. Rubene reported no relevant financial disclosures.

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

BUDAPEST, Hungary — A single dose of intravenous esketamine during delivery or cesarean section appears to reduce the risk for postpartum depression (PPD) by more than 50% in the first 6 weeks, a new meta-analysis suggested. However, the long-term safety and efficacy of the drug are still unclear.

Study investigator Angelina Kozhokar, MD, Department of Medicine, Universitat Internacional de Catalunya, Barcelona, Sant Cugat del Valles, Spain, told this news organization she was “surprised” by the size of the PPD risk reduction associated with the drug.

However, she added, “it’s important to consider that preliminary studies on a lot of medications used for postpartum depression have also shown very big effect sizes.”

Dr. Kozhokar believes that as more studies examining esketamine for PPD are conducted, “we will see more definitive effect sizes, and the safety profile for this new treatment” will become clearer.

The findings were presented at the European Psychiatric Association (EPA) Congress.
 

Significant Reduction

As previously reported by this news organization, intranasal esketamine (Spravato, Janssen) was shown to be superior to extended-release quetiapine (Seroquel, AstraZeneca), an atypical antipsychotic, for treatment-resistant depression.

With up to 13% of women experiencing PPD in the perinatal period, the researchers sought to examine the impact of esketamine administered prophylactically during labor or cesarean section on the incidence of the disorder.

They searched the PubMed, Scopus, and Google Scholar databases for randomized controlled trials examining the efficacy of esketamine and screened for PPD using the Edinburgh Postpartum Depression Scale (EPDS).

While the intranasal spray is the only form of esketamine approved by the US Food and Drug Administration, an injectable solution is also available. The researchers identified seven eligible trials that included a total of 1287 women. Of these participants, 635 (49.3%) received esketamine. Esketamine was delivered as either patient-controlled intravenous analgesia or a single intravenous dose during delivery or cesarean section.

Across the seven trials, esketamine was associated with a significant reduction in PPD at 1 week after delivery at a risk ratio vs placebo of 0.459 (P < .05). At 6 weeks, the reduction in PPD incidence was maintained, at a risk ratio of 0.470 (P < .01).

However, Dr. Kozhokar pointed out that the EPDS is a subjective measure of PPD, and the studies used different cutoff scores for depression, ranging from 9 to 13 points.
 

Unanswered Questions

She also cautioned that the adverse effects of esketamine on maternal and neonatal health need to be assessed, as well as the long-term cost/benefit ratio of prophylactic treatment.

All seven studies included in the meta-analysis were conducted in China, which limits the generalizability of the findings.

“I suppose they were quicker to get to the topic than the rest of the world,” Dr. Kozhokar said, while also suggesting that, potentially, “we are more regulated here in Europe.”

She pointed out that there is “an important safety concern about the use of medications such as ketamine and esketamine” in terms of the potential for addiction and the effect on babies over the long term, which is currently unknown.

Session chair Linda Rubene, MD, a psychiatrist in the Department of Psychiatry and Narcology at Riga Stradinš University, Riga, Latvia, welcomed the study.

“If we had more options to treat postpartum depression and to treat depression during pregnancy, it would be a great improvement,” she said.

However, she noted, because there are no long-term outcome data for esketamine in PPD, more study is needed. It is possible, said Dr. Rubene, that esketamine may not work for all women.

The investigators and Dr. Rubene reported no relevant financial disclosures.

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

BUDAPEST, Hungary — A single dose of intravenous esketamine during delivery or cesarean section appears to reduce the risk for postpartum depression (PPD) by more than 50% in the first 6 weeks, a new meta-analysis suggested. However, the long-term safety and efficacy of the drug are still unclear.

Study investigator Angelina Kozhokar, MD, Department of Medicine, Universitat Internacional de Catalunya, Barcelona, Sant Cugat del Valles, Spain, told this news organization she was “surprised” by the size of the PPD risk reduction associated with the drug.

However, she added, “it’s important to consider that preliminary studies on a lot of medications used for postpartum depression have also shown very big effect sizes.”

Dr. Kozhokar believes that as more studies examining esketamine for PPD are conducted, “we will see more definitive effect sizes, and the safety profile for this new treatment” will become clearer.

The findings were presented at the European Psychiatric Association (EPA) Congress.
 

Significant Reduction

As previously reported by this news organization, intranasal esketamine (Spravato, Janssen) was shown to be superior to extended-release quetiapine (Seroquel, AstraZeneca), an atypical antipsychotic, for treatment-resistant depression.

With up to 13% of women experiencing PPD in the perinatal period, the researchers sought to examine the impact of esketamine administered prophylactically during labor or cesarean section on the incidence of the disorder.

They searched the PubMed, Scopus, and Google Scholar databases for randomized controlled trials examining the efficacy of esketamine and screened for PPD using the Edinburgh Postpartum Depression Scale (EPDS).

While the intranasal spray is the only form of esketamine approved by the US Food and Drug Administration, an injectable solution is also available. The researchers identified seven eligible trials that included a total of 1287 women. Of these participants, 635 (49.3%) received esketamine. Esketamine was delivered as either patient-controlled intravenous analgesia or a single intravenous dose during delivery or cesarean section.

Across the seven trials, esketamine was associated with a significant reduction in PPD at 1 week after delivery at a risk ratio vs placebo of 0.459 (P < .05). At 6 weeks, the reduction in PPD incidence was maintained, at a risk ratio of 0.470 (P < .01).

However, Dr. Kozhokar pointed out that the EPDS is a subjective measure of PPD, and the studies used different cutoff scores for depression, ranging from 9 to 13 points.
 

Unanswered Questions

She also cautioned that the adverse effects of esketamine on maternal and neonatal health need to be assessed, as well as the long-term cost/benefit ratio of prophylactic treatment.

All seven studies included in the meta-analysis were conducted in China, which limits the generalizability of the findings.

“I suppose they were quicker to get to the topic than the rest of the world,” Dr. Kozhokar said, while also suggesting that, potentially, “we are more regulated here in Europe.”

She pointed out that there is “an important safety concern about the use of medications such as ketamine and esketamine” in terms of the potential for addiction and the effect on babies over the long term, which is currently unknown.

Session chair Linda Rubene, MD, a psychiatrist in the Department of Psychiatry and Narcology at Riga Stradinš University, Riga, Latvia, welcomed the study.

“If we had more options to treat postpartum depression and to treat depression during pregnancy, it would be a great improvement,” she said.

However, she noted, because there are no long-term outcome data for esketamine in PPD, more study is needed. It is possible, said Dr. Rubene, that esketamine may not work for all women.

The investigators and Dr. Rubene reported no relevant financial disclosures.

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

Premenstrual disorders (PMDs) and perinatal depression (PND) appear to have a bidirectional association, a Swedish national registry-based analysis found.

In women with PND, 2.9% had PMDs before pregnancy vs 0.6% in a matched cohort of unaffected women, according to an international team led by Quian Yang, MD, PhD, of the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, Sweden. Their study appears in PLoS Medicine.

“Preconception and maternity care providers should be aware of the risk of developing perinatal depression among women with a history of PMDs,” Dr. Yang said in an interview. “Healthcare providers may inform women with perinatal depression about the potential risk of PMDs when menstruation returns after childbirth.” She recommended screening as part of routine perinatal care to identify and treat the condition at an early stage. Counseling and medication may help prevent adverse consequences.

In other findings, the correlation with PMDs held for both prenatal and postnatal depression, regardless of any history of psychiatric disorders and also in full-sister comparisons, the authors noted, with a stronger correlation in the absence of psychiatric disorders (P for interaction <.001).

“Interestingly, we noted a stronger association between PMDs and subsequent PND than the association in the other direction, Dr. Yang said. And although many experience PMD symptom onset in adolescence, symptom worsening has been reported with increasing age and parity. “It is possible that women with milder premenstrual symptoms experienced worse symptoms after pregnancy and are therefore first diagnosed with PMD after pregnancy,” the authors hypothesized.

Both PMDs and PND share depressive symptomatology and onset coinciding with hormonal fluctuations, particularly estrogen and progesterone, suggesting a shared etiology, Dr. Yang explained. “It’s plausible that an abnormal response to natural hormone fluctuations predisposes women to both PMDs and PND. However, the underlying mechanism is complex, and future research is needed to reveal the underlying etiology.”

Affecting a majority of women of reproductive age to some degree, PMDs in certain women can cause significant functional impairment and, when severe, have been linked to increased risks of accidents and suicidal behavior. The psychological symptoms of the more serious form, premenstrual dysphoric disorder, for example, are associated with a 50%-78% lifetime risk for psychiatric disorders, including major depressive, dysthymic, seasonal affective, and generalized anxiety disorders, as well as suicidality.

Mood disorders are common in pregnancy and the postpartum period.

The Swedish Study

In 1.8 million singleton pregnancies in Sweden during 2001-2018, the investigators identified 84,949 women with PND and 849,482 unaffected women and individually matched them 10:1 by age and calendar year. Incident PND and PMDs were identified through clinical diagnoses or prescribed medications, and adjustment was made for such demographics as country of birth, educational level, region of residency, and cohabitation status.

In an initial matched-cohort case-control study with a mean follow-up of 6.9 years, PMDs were associated with a nearly five times higher risk of subsequent PND (odds ratio, 4.76; 95% CI, 4.52-5.01; P <.001).

In another matched cohort with a mean follow-up of 7.0 years, there were 4227 newly diagnosed PMDs in women with PND (incidence rate [IR], 7.6/1000 person-years) and 21,326 among controls (IR, 3.8/1000). Compared with matched controls, women with PND were at almost twice the risk of subsequent PMDs (hazard ratio, 1.81; 95% CI, 1.74-1.88; P <.001).

Commenting on the study but not involved in it, Bernard L. Harlow, PhD, a professor of epidemiology at Boston University School of Public Health in Massachusetts who specializes in epidemiologic studies of female reproductive disorders, said he was not surprised at these findings, which clearly support the need for PMD screening in mothers-to-be. “Anything that is easy to measure and noninvasive that will minimize the risk of postpartum depression should be part of the standard of care during the prenatal period.” As to safety: If treatment is indicated, he added, “studies have shown that the risk to the mother and child is much greater if the mother’s mood disorder is not controlled than any risk to the baby due to depression treatment.” But though PMDs may be predictive of PND, there are still barriers to actual PND care. A 2023 analysis reported that 65% of mothers-to-be who screened positive for metal health comorbidities were not referred for treatment.

Dr. Yang and colleagues acknowledged that their findings may not be generalizable to mild forms of these disorders since the data were based on clinical diagnoses and prescriptions.

The study was supported by the Chinese Scholarship Council, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, and the Icelandic Research Fund. The authors and Dr. Harlow had no relevant competing interests to disclose.

Premenstrual disorders (PMDs) and perinatal depression (PND) appear to have a bidirectional association, a Swedish national registry-based analysis found.

In women with PND, 2.9% had PMDs before pregnancy vs 0.6% in a matched cohort of unaffected women, according to an international team led by Quian Yang, MD, PhD, of the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, Sweden. Their study appears in PLoS Medicine.

“Preconception and maternity care providers should be aware of the risk of developing perinatal depression among women with a history of PMDs,” Dr. Yang said in an interview. “Healthcare providers may inform women with perinatal depression about the potential risk of PMDs when menstruation returns after childbirth.” She recommended screening as part of routine perinatal care to identify and treat the condition at an early stage. Counseling and medication may help prevent adverse consequences.

In other findings, the correlation with PMDs held for both prenatal and postnatal depression, regardless of any history of psychiatric disorders and also in full-sister comparisons, the authors noted, with a stronger correlation in the absence of psychiatric disorders (P for interaction <.001).

“Interestingly, we noted a stronger association between PMDs and subsequent PND than the association in the other direction, Dr. Yang said. And although many experience PMD symptom onset in adolescence, symptom worsening has been reported with increasing age and parity. “It is possible that women with milder premenstrual symptoms experienced worse symptoms after pregnancy and are therefore first diagnosed with PMD after pregnancy,” the authors hypothesized.

Both PMDs and PND share depressive symptomatology and onset coinciding with hormonal fluctuations, particularly estrogen and progesterone, suggesting a shared etiology, Dr. Yang explained. “It’s plausible that an abnormal response to natural hormone fluctuations predisposes women to both PMDs and PND. However, the underlying mechanism is complex, and future research is needed to reveal the underlying etiology.”

Affecting a majority of women of reproductive age to some degree, PMDs in certain women can cause significant functional impairment and, when severe, have been linked to increased risks of accidents and suicidal behavior. The psychological symptoms of the more serious form, premenstrual dysphoric disorder, for example, are associated with a 50%-78% lifetime risk for psychiatric disorders, including major depressive, dysthymic, seasonal affective, and generalized anxiety disorders, as well as suicidality.

Mood disorders are common in pregnancy and the postpartum period.

The Swedish Study

In 1.8 million singleton pregnancies in Sweden during 2001-2018, the investigators identified 84,949 women with PND and 849,482 unaffected women and individually matched them 10:1 by age and calendar year. Incident PND and PMDs were identified through clinical diagnoses or prescribed medications, and adjustment was made for such demographics as country of birth, educational level, region of residency, and cohabitation status.

In an initial matched-cohort case-control study with a mean follow-up of 6.9 years, PMDs were associated with a nearly five times higher risk of subsequent PND (odds ratio, 4.76; 95% CI, 4.52-5.01; P <.001).

In another matched cohort with a mean follow-up of 7.0 years, there were 4227 newly diagnosed PMDs in women with PND (incidence rate [IR], 7.6/1000 person-years) and 21,326 among controls (IR, 3.8/1000). Compared with matched controls, women with PND were at almost twice the risk of subsequent PMDs (hazard ratio, 1.81; 95% CI, 1.74-1.88; P <.001).

Commenting on the study but not involved in it, Bernard L. Harlow, PhD, a professor of epidemiology at Boston University School of Public Health in Massachusetts who specializes in epidemiologic studies of female reproductive disorders, said he was not surprised at these findings, which clearly support the need for PMD screening in mothers-to-be. “Anything that is easy to measure and noninvasive that will minimize the risk of postpartum depression should be part of the standard of care during the prenatal period.” As to safety: If treatment is indicated, he added, “studies have shown that the risk to the mother and child is much greater if the mother’s mood disorder is not controlled than any risk to the baby due to depression treatment.” But though PMDs may be predictive of PND, there are still barriers to actual PND care. A 2023 analysis reported that 65% of mothers-to-be who screened positive for metal health comorbidities were not referred for treatment.

Dr. Yang and colleagues acknowledged that their findings may not be generalizable to mild forms of these disorders since the data were based on clinical diagnoses and prescriptions.

The study was supported by the Chinese Scholarship Council, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, and the Icelandic Research Fund. The authors and Dr. Harlow had no relevant competing interests to disclose.

Premenstrual disorders (PMDs) and perinatal depression (PND) appear to have a bidirectional association, a Swedish national registry-based analysis found.

In women with PND, 2.9% had PMDs before pregnancy vs 0.6% in a matched cohort of unaffected women, according to an international team led by Quian Yang, MD, PhD, of the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, Sweden. Their study appears in PLoS Medicine.

“Preconception and maternity care providers should be aware of the risk of developing perinatal depression among women with a history of PMDs,” Dr. Yang said in an interview. “Healthcare providers may inform women with perinatal depression about the potential risk of PMDs when menstruation returns after childbirth.” She recommended screening as part of routine perinatal care to identify and treat the condition at an early stage. Counseling and medication may help prevent adverse consequences.

In other findings, the correlation with PMDs held for both prenatal and postnatal depression, regardless of any history of psychiatric disorders and also in full-sister comparisons, the authors noted, with a stronger correlation in the absence of psychiatric disorders (P for interaction <.001).

“Interestingly, we noted a stronger association between PMDs and subsequent PND than the association in the other direction, Dr. Yang said. And although many experience PMD symptom onset in adolescence, symptom worsening has been reported with increasing age and parity. “It is possible that women with milder premenstrual symptoms experienced worse symptoms after pregnancy and are therefore first diagnosed with PMD after pregnancy,” the authors hypothesized.

Both PMDs and PND share depressive symptomatology and onset coinciding with hormonal fluctuations, particularly estrogen and progesterone, suggesting a shared etiology, Dr. Yang explained. “It’s plausible that an abnormal response to natural hormone fluctuations predisposes women to both PMDs and PND. However, the underlying mechanism is complex, and future research is needed to reveal the underlying etiology.”

Affecting a majority of women of reproductive age to some degree, PMDs in certain women can cause significant functional impairment and, when severe, have been linked to increased risks of accidents and suicidal behavior. The psychological symptoms of the more serious form, premenstrual dysphoric disorder, for example, are associated with a 50%-78% lifetime risk for psychiatric disorders, including major depressive, dysthymic, seasonal affective, and generalized anxiety disorders, as well as suicidality.

Mood disorders are common in pregnancy and the postpartum period.

The Swedish Study

In 1.8 million singleton pregnancies in Sweden during 2001-2018, the investigators identified 84,949 women with PND and 849,482 unaffected women and individually matched them 10:1 by age and calendar year. Incident PND and PMDs were identified through clinical diagnoses or prescribed medications, and adjustment was made for such demographics as country of birth, educational level, region of residency, and cohabitation status.

In an initial matched-cohort case-control study with a mean follow-up of 6.9 years, PMDs were associated with a nearly five times higher risk of subsequent PND (odds ratio, 4.76; 95% CI, 4.52-5.01; P <.001).

In another matched cohort with a mean follow-up of 7.0 years, there were 4227 newly diagnosed PMDs in women with PND (incidence rate [IR], 7.6/1000 person-years) and 21,326 among controls (IR, 3.8/1000). Compared with matched controls, women with PND were at almost twice the risk of subsequent PMDs (hazard ratio, 1.81; 95% CI, 1.74-1.88; P <.001).

Commenting on the study but not involved in it, Bernard L. Harlow, PhD, a professor of epidemiology at Boston University School of Public Health in Massachusetts who specializes in epidemiologic studies of female reproductive disorders, said he was not surprised at these findings, which clearly support the need for PMD screening in mothers-to-be. “Anything that is easy to measure and noninvasive that will minimize the risk of postpartum depression should be part of the standard of care during the prenatal period.” As to safety: If treatment is indicated, he added, “studies have shown that the risk to the mother and child is much greater if the mother’s mood disorder is not controlled than any risk to the baby due to depression treatment.” But though PMDs may be predictive of PND, there are still barriers to actual PND care. A 2023 analysis reported that 65% of mothers-to-be who screened positive for metal health comorbidities were not referred for treatment.

Dr. Yang and colleagues acknowledged that their findings may not be generalizable to mild forms of these disorders since the data were based on clinical diagnoses and prescriptions.

The study was supported by the Chinese Scholarship Council, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, and the Icelandic Research Fund. The authors and Dr. Harlow had no relevant competing interests to disclose.

Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.

Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).

Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.

The Study

In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.

Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.

Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.

On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.

A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.

These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.

Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.

The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”

This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.

Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.

Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).

Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.

The Study

In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.

Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.

Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.

On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.

A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.

These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.

Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.

The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”

This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.

Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.

Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).

Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.

The Study

In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.

Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.

Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.

On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.

A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.

These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.

Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.

The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”

This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

When her obstetrician-gynecologist recommended a mammogram, Emily Legg didn’t hesitate to schedule an appointment for the screening.

Her grandmother had been diagnosed with breast cancer and her father died of prostate cancer in his mid-50s. Ms. Legg also has polycystic ovary syndrome (PCOS), which increases the risk of some cancers.

Having just turned 40, Ms. Legg said she was determined to be as proactive as possible with cancer screenings.

Before the mammogram, she arranged for childcare for her 6-month-old daughter and filled out a required questionnaire online that asked about her history and health conditions. When the appointment day arrived, Ms. Legg made the 30-minute drive to the clinic where she was prepped for the procedure and escorted to the mammography room.

But just before the screening started, Ms. Legg happened to mention to the technician that she was breastfeeding. The surprised tech immediately halted the procedure, Ms. Legg said. Because of increased breast density caused by nursing, Ms. Legg was told to wait at least 6 weeks after weaning for a mammogram.

“I didn’t even consider that breastfeeding might prevent me from getting a mammogram,” said Ms. Legg, a writing professor from Hamilton, Ohio. “I had to go home. I was frustrated, mostly because I had driven all that way. I had hyped myself up. I had childcare in line. And now I had to wait until my daughter weaned? At the time, I didn’t know if my daughter was going to breastfeed for 2 years or be done at 6 months.”

Considering her family background, Ms. Legg worried about not receiving the screening. Her sister had recently undergone a mammogram while she was breastfeeding without any problems.

When she did research, Ms. Legg found conflicting information about the subject online so she turned to Reddit, where she started a thread asking if other moms over 40 had experienced similar issues. Dozens of moms responded with questions and concerns on the subject. Some wrote about being denied a mammogram while breastfeeding, while others wrote they received the procedure without question. Guidance from health professionals on the topic appeared to vastly differ.

“That’s why I turned to [social media] because I wasn’t finding anything else,” Ms. Legg said. “There’s just a lack of clear information. As an older mom, there’s less information out there for being postpartum and being over 40.”

Confusion over screenings during breastfeeding comes at the intersection of national guidelines lowering the recommended age for first mammograms, more women having babies later in life, and women getting breast cancer earlier.

Legg family

Most physician specialty associations agree that mammography is safe for breastfeeding patients and that they need not delay routine screenings. However, the safety of breast imaging during pregnancy and lactation is not well advertised, said Molly Peterson, MD, a radiologist based in St. Frances, Wisconsin, and lead author of a 2023 article about breast imaging during pregnancy and lactation in RadioGraphics, a journal of the Radiological Society of North America.

Conflicting information from nonscientific resources adds to the confusion, Dr. Peterson said. At the same time, health providers along the care spectrum may be uncertain about what imaging is safe and reasonable. Recommendations about mammography and lactation can also vary by institution, screening experts say.

“I’ve talked with pregnant and breastfeeding patients, both younger and older, who were unsure if they could have mammograms,” Dr. Peterson said. “I’ve also fielded questions from technologists, unclear what imaging we can offer these patients. ... Educating health professionals about evidence-based guidelines for screening and diagnostic imaging and reassuring patients about the safety of breast imaging during pregnancy and lactation is thus more important than ever.”
 

Differing Guidelines, Case-by-Case Considerations

The RadioGraphics paper emphasizes that both screening and diagnostic imaging can be safely performed using protocols based on age, breast cancer risk, and whether the patient is pregnant or lactating.

The American College of Radiology (ACR) Appropriateness Criteria also support mammography for certain patients during lactation. The guidelines state there is no contraindication to performing mammography during lactation, but note that challenges in evaluation can arise because of the unique physiological and structural breast changes that can occur.

“Hormones can change breast density and size of the breast, which could limit the clinical examination, mimic pathology, and obscure mammographic findings,” said Stamatia V. Destounis, MD, FACR, chair of the ACR Breast Imaging Commission. “It is important the patient pumps right before the mammogram or brings the baby to breastfeed prior to the imaging examination to offer the best imaging evaluation and reduce breast density as much as possible.”

In those patients who choose to prolong breastfeeding and are of the age to be screened, it is important they undergo yearly clinical breast exams, perform breast self-exams, and discuss breast cancer screening with their healthcare provider, she said. “They should not delay a routine screening mammogram. Most patients have dense breast tissue at this time, and frequently a breast ultrasound may be performed also.”

The American College of Obstetricians and Gynecologists (ACOG) does not have specific guidelines about breastfeeding mothers and mammography recommendations. Breastfeeding patients should discuss with their physicians or midwives the pros and cons of mammography, taking into account personal risk factors and how long they plan to nurse, said Joshua Copel, MD, vice chair of obstetrics, gynecology and reproductive sciences at Yale Medicine, New Haven, Connecticut, and a member of ACOG’s Committee on Obstetric Practice.

“The question for anybody to address with their physician will be, ‘Is my risk of breast cancer high enough that I should take that small risk that they’re going to over- or underread the mammogram because of my nursing status? Or should I wait until I wean the baby and have the mammogram then?’” he said.

Institutional and practice protocols meanwhile, can depend on a patient’s cancer risk.

Guidelines at the University of Wisconsin, for instance, advise that lactating patients 40 or over who are at average risk, wait 6-8 weeks after cessation of breastfeeding, said Alison Gegios, MD, a radiologist and assistant professor in breast imaging at the University of Wisconsin School of Medicine and Public Health. Average risk is defined as less than a 15% lifetime risk of breast cancer, she said.

Dr. Gegios, a coauthor on the RadioGraphics paper, said her institution recommends screening mammography if lactating patients are at intermediate or high risk, and are over 30. In such cases however, screening is generally deferred until 3-6 months after delivery, she noted.

“If patients are high risk, it’s also important to do screening breast MRIs,” Dr. Gegios said. “Studies have shown that screening breast MRIs are effective in breastfeeding patients despite their increased background parenchymal enhancement because breast cancer still stands out on our maximum intensity projections and stands out on the exam from the background.”
 

How to Clear Up Confusion, Promote Consistency

After her experience at the mammography practice, Ms. Legg went home and immediately sent a message to her ob.gyn. about what happened.

The doctor was similarly surprised and frustrated that Ms. Legg wasn’t able to get the mammogram, she said. To get around the difference in protocols, Ms. Legg’s ob.gyn. referred her to a high-risk clinic in Cincinnati. Ms. Legg’s history qualified her as high risk and she received genetic testing and a breast ultrasound at the clinic, she said.

“The ultrasound showed some shady spots,” Ms. Legg recalled. “They weren’t quite sure what they were. Another ultrasound later, they determined the spots were symmetrical and it ended up not being anything [serious]. Genetic-wise, I did not have any markers for cancer.”

Ms. Legg was relieved and she eventually received a mammogram when she finished breastfeeding, she said. However, she feels the overlap of older, breastfeeding moms and mammography guidelines deserves more attention.

“I would encourage all of us in the ‘geriatric mother’s club,’ to advocate for yourself, do your research, and also turn to your medical professionals and ask questions,” she said. “Make sure you know what they recommend for moms who are older and just had a baby.”

On the provider side, Dr. Destounis said physicians should revisit with patients the most updated guidelines about breastfeeding and mammography at routine appointments.

“Patients and their physicians have to have communication about screening for breast cancer if they are of screening age,” she said.

Dr. Copel advises physicians to run through the risks and benefits of mammograms with older, breastfeeding patients and make a shared decision. “It’s all going to vary with the individual circumstances,” he said. “If someone [has] a BRCA gene and their sister and mother had breast cancer, maybe it’s worth it. If somebody has absolutely no family history and just crossed the threshold for meeting a mammogram [recommendation], then sure, wait.”

Ms. Legg would like to see more professional literature and educational material directed toward the older, breastfeeding population about mammograms.

“At minimum, work together across departments to create an intake form, a questionnaire that is inclusive of everything,” she said. “There should be a question before you even get to the tech that asks, ‘Are you breastfeeding?’ ”

TOPLINE:

A study comparing cervical pessary and vaginal progesterone for the prevention of preterm birth in women with a short cervix of ≤ 35 mm found no significant difference between the interventions for perinatal complications. Among women with a cervical length of ≤ 25 mm, however, pessaries appeared to be less effective at preventing spontaneous preterm birth and adverse outcomes, according to the researchers.

METHODOLOGY:

• Researchers conducted an open-label, randomized controlled trial at 20 hospitals and five obstetric ultrasound practices in the Netherlands.
• The study included 635 women with healthy singleton pregnancies between 18 and 22 weeks’ gestation and an asymptomatic short cervix of ≤ 35 mm. Participants had no history of spontaneous preterm birth.
• Women were randomly assigned to receive either an Arabin cervical pessary or 200 mg/d vaginal progesterone for ≤ 36 weeks of gestation.
• The investigators examined a composite measure of adverse perinatal outcomes, including  (grade, > 1), chronic lung disease,  (grade, III or IV),  (stage, > 1), , stillbirth, and death of the baby.

TAKEAWAY:

• Adverse perinatal outcomes occurred in 6% of each treatment group, and the rate of spontaneous preterm birth did not differ significantly between the groups.
• In a subgroup analysis of 131 patients with a cervical length of ≤ 25 mm, spontaneous preterm birth at < 28 weeks occurred more often in the pessary group (16% vs 4%).
• Adverse perinatal outcomes also seemed to occur more frequently in the pessary group (24% vs 12%; relative risk, 2.1 [95% CI, 0.95-4.60]), in the subgroup analysis, according to the researchers.

IN PRACTICE:

“Even though the study was not powered for the subgroup with a short cervix of ≤ 25 mm, results suggest that a cervical pessary should not be used as preventive treatment in this group,” the researchers wrote.

SOURCE:

The study was led by Charlotte E. van Dijk, MD, with Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. It was published online in The BMJ.

LIMITATIONS:

The researchers were unable to mask the treatment groups, which could introduce bias. The study’s reliance on self-reported medication adherence in the progesterone group and a lack of extra training for pessary placement might have influenced the outcomes, the researchers noted.

DISCLOSURES:

The study was supported by Stichting Stoptevroegbevallen, a nonprofit research foundation. An author disclosed financial ties with Merck.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A study comparing cervical pessary and vaginal progesterone for the prevention of preterm birth in women with a short cervix of ≤ 35 mm found no significant difference between the interventions for perinatal complications. Among women with a cervical length of ≤ 25 mm, however, pessaries appeared to be less effective at preventing spontaneous preterm birth and adverse outcomes, according to the researchers.

METHODOLOGY:

• Researchers conducted an open-label, randomized controlled trial at 20 hospitals and five obstetric ultrasound practices in the Netherlands.
• The study included 635 women with healthy singleton pregnancies between 18 and 22 weeks’ gestation and an asymptomatic short cervix of ≤ 35 mm. Participants had no history of spontaneous preterm birth.
• Women were randomly assigned to receive either an Arabin cervical pessary or 200 mg/d vaginal progesterone for ≤ 36 weeks of gestation.
• The investigators examined a composite measure of adverse perinatal outcomes, including  (grade, > 1), chronic lung disease,  (grade, III or IV),  (stage, > 1), , stillbirth, and death of the baby.

TAKEAWAY:

• Adverse perinatal outcomes occurred in 6% of each treatment group, and the rate of spontaneous preterm birth did not differ significantly between the groups.
• In a subgroup analysis of 131 patients with a cervical length of ≤ 25 mm, spontaneous preterm birth at < 28 weeks occurred more often in the pessary group (16% vs 4%).
• Adverse perinatal outcomes also seemed to occur more frequently in the pessary group (24% vs 12%; relative risk, 2.1 [95% CI, 0.95-4.60]), in the subgroup analysis, according to the researchers.

IN PRACTICE:

“Even though the study was not powered for the subgroup with a short cervix of ≤ 25 mm, results suggest that a cervical pessary should not be used as preventive treatment in this group,” the researchers wrote.

SOURCE:

The study was led by Charlotte E. van Dijk, MD, with Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. It was published online in The BMJ.

LIMITATIONS:

The researchers were unable to mask the treatment groups, which could introduce bias. The study’s reliance on self-reported medication adherence in the progesterone group and a lack of extra training for pessary placement might have influenced the outcomes, the researchers noted.

DISCLOSURES:

The study was supported by Stichting Stoptevroegbevallen, a nonprofit research foundation. An author disclosed financial ties with Merck.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A study comparing cervical pessary and vaginal progesterone for the prevention of preterm birth in women with a short cervix of ≤ 35 mm found no significant difference between the interventions for perinatal complications. Among women with a cervical length of ≤ 25 mm, however, pessaries appeared to be less effective at preventing spontaneous preterm birth and adverse outcomes, according to the researchers.

METHODOLOGY:

• Researchers conducted an open-label, randomized controlled trial at 20 hospitals and five obstetric ultrasound practices in the Netherlands.
• The study included 635 women with healthy singleton pregnancies between 18 and 22 weeks’ gestation and an asymptomatic short cervix of ≤ 35 mm. Participants had no history of spontaneous preterm birth.
• Women were randomly assigned to receive either an Arabin cervical pessary or 200 mg/d vaginal progesterone for ≤ 36 weeks of gestation.
• The investigators examined a composite measure of adverse perinatal outcomes, including  (grade, > 1), chronic lung disease,  (grade, III or IV),  (stage, > 1), , stillbirth, and death of the baby.

TAKEAWAY:

• Adverse perinatal outcomes occurred in 6% of each treatment group, and the rate of spontaneous preterm birth did not differ significantly between the groups.
• In a subgroup analysis of 131 patients with a cervical length of ≤ 25 mm, spontaneous preterm birth at < 28 weeks occurred more often in the pessary group (16% vs 4%).
• Adverse perinatal outcomes also seemed to occur more frequently in the pessary group (24% vs 12%; relative risk, 2.1 [95% CI, 0.95-4.60]), in the subgroup analysis, according to the researchers.

IN PRACTICE:

“Even though the study was not powered for the subgroup with a short cervix of ≤ 25 mm, results suggest that a cervical pessary should not be used as preventive treatment in this group,” the researchers wrote.

SOURCE:

The study was led by Charlotte E. van Dijk, MD, with Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. It was published online in The BMJ.

LIMITATIONS:

The researchers were unable to mask the treatment groups, which could introduce bias. The study’s reliance on self-reported medication adherence in the progesterone group and a lack of extra training for pessary placement might have influenced the outcomes, the researchers noted.

DISCLOSURES:

The study was supported by Stichting Stoptevroegbevallen, a nonprofit research foundation. An author disclosed financial ties with Merck.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Using polygenic risk scores along with positive family histories and breast cancer-associated gene mutations improves risk stratification for breast cancer screening.

METHODOLOGY:

A polygenic risk score — a measure of an individual’s risk for a disease based on the estimated effects of many genetic variants — is not typically included alongside family histories and pathogenic variants of genes, such as BRCA1 and PALB2, when assessing a woman’s risk for breast cancer and the need for earlier or more frequent screening.

To assess the potential for a polygenic risk score to improve breast cancer risk stratification, investigators in Finland used a nationwide genetic database to calculate polygenic risk score scores for 117,252 women and then linked the scores to their breast cancer outcomes, using the country’s nationwide mammography screening program, which screens women, ages 50-69 years, every 2 years.

The researchers evaluated the use of polygenic risk scores both alone and in combination with family histories and pathogenic variants — specifically, CHEK2 and PALB2 variants common in Finland.

The researchers also looked at how well polygenic risk scores predicted a person’s risk for any breast cancer as well as invasive, in situ, and bilateral at three timepoints: before, during, and after screening age.

TAKEAWAY:

Compared with a lower polygenic risk score (below 90%), a high polygenic risk score — a score in the top 10% — was associated with more than a twofold higher risk for any breast cancer before, during, and after screening age (hazard ratio [HR], 2.50, 2.38, and 2.11, respectively). Pathogenic variants and family histories led to similar risk assessments (HR, 3.13, 2.30, and 1.95, respectively, for pathogenic variants; HR, 1.97, 1.96, and 1.68, respectively, for family history).

A high polygenic risk score had a positive predictive value of 39.5% for a breast cancer diagnosis after a positive screening mammography, about the same as positive family history (35.5%) and pathogenic variants (35.9%). Combining a high polygenic risk score with a positive family history increased the positive predictive value to 44.6% and with pathogenic variant carriers increased the positive predictive value to 50.6%.

A high polygenic risk score was also associated with a twofold higher risk for interval breast cancer — a cancer diagnosed between screenings — and a higher risk for bilateral breast cancer during screening ages (HR, 4.71), suggesting that women with high scores may benefit from a shorter time interval between screenings or earlier screening, the researchers said.

Women with scores in the bottom 10% had a very low risk for both interval and screen-detected cancers. Those with negative family histories and no pathogenic variants did not reach the 2% cumulative incidence threshold for breast cancer screening until age 62 years, “suggesting opportunities for less frequent screens,” the researchers noted.

IN PRACTICE:

This study demonstrates the effectiveness of using a breast cancer polygenic risk score for risk stratification, “with optimal stratification reached through combining” this information with family history and pathogenic variants, the researchers concluded.

SOURCE:

The study, led by Nina Mars, MD, PhD, of the University of Helsinki, Helsinki, Finland, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The work was limited largely to people with Finnish genetic ancestry. The benefits of including polygenic risk scores in screening programs need to be confirmed in clinical trials in areas with broader genetic ancestry; several trials are underway in the United States and elsewhere.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 research and innovation program, the Cancer Foundation Finland, and others. The investigators didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Using polygenic risk scores along with positive family histories and breast cancer-associated gene mutations improves risk stratification for breast cancer screening.

METHODOLOGY:

A polygenic risk score — a measure of an individual’s risk for a disease based on the estimated effects of many genetic variants — is not typically included alongside family histories and pathogenic variants of genes, such as BRCA1 and PALB2, when assessing a woman’s risk for breast cancer and the need for earlier or more frequent screening.

To assess the potential for a polygenic risk score to improve breast cancer risk stratification, investigators in Finland used a nationwide genetic database to calculate polygenic risk score scores for 117,252 women and then linked the scores to their breast cancer outcomes, using the country’s nationwide mammography screening program, which screens women, ages 50-69 years, every 2 years.

The researchers evaluated the use of polygenic risk scores both alone and in combination with family histories and pathogenic variants — specifically, CHEK2 and PALB2 variants common in Finland.

The researchers also looked at how well polygenic risk scores predicted a person’s risk for any breast cancer as well as invasive, in situ, and bilateral at three timepoints: before, during, and after screening age.

TAKEAWAY:

Compared with a lower polygenic risk score (below 90%), a high polygenic risk score — a score in the top 10% — was associated with more than a twofold higher risk for any breast cancer before, during, and after screening age (hazard ratio [HR], 2.50, 2.38, and 2.11, respectively). Pathogenic variants and family histories led to similar risk assessments (HR, 3.13, 2.30, and 1.95, respectively, for pathogenic variants; HR, 1.97, 1.96, and 1.68, respectively, for family history).

A high polygenic risk score had a positive predictive value of 39.5% for a breast cancer diagnosis after a positive screening mammography, about the same as positive family history (35.5%) and pathogenic variants (35.9%). Combining a high polygenic risk score with a positive family history increased the positive predictive value to 44.6% and with pathogenic variant carriers increased the positive predictive value to 50.6%.

A high polygenic risk score was also associated with a twofold higher risk for interval breast cancer — a cancer diagnosed between screenings — and a higher risk for bilateral breast cancer during screening ages (HR, 4.71), suggesting that women with high scores may benefit from a shorter time interval between screenings or earlier screening, the researchers said.

Women with scores in the bottom 10% had a very low risk for both interval and screen-detected cancers. Those with negative family histories and no pathogenic variants did not reach the 2% cumulative incidence threshold for breast cancer screening until age 62 years, “suggesting opportunities for less frequent screens,” the researchers noted.

IN PRACTICE:

This study demonstrates the effectiveness of using a breast cancer polygenic risk score for risk stratification, “with optimal stratification reached through combining” this information with family history and pathogenic variants, the researchers concluded.

SOURCE:

The study, led by Nina Mars, MD, PhD, of the University of Helsinki, Helsinki, Finland, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The work was limited largely to people with Finnish genetic ancestry. The benefits of including polygenic risk scores in screening programs need to be confirmed in clinical trials in areas with broader genetic ancestry; several trials are underway in the United States and elsewhere.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 research and innovation program, the Cancer Foundation Finland, and others. The investigators didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Using polygenic risk scores along with positive family histories and breast cancer-associated gene mutations improves risk stratification for breast cancer screening.

METHODOLOGY:

A polygenic risk score — a measure of an individual’s risk for a disease based on the estimated effects of many genetic variants — is not typically included alongside family histories and pathogenic variants of genes, such as BRCA1 and PALB2, when assessing a woman’s risk for breast cancer and the need for earlier or more frequent screening.

To assess the potential for a polygenic risk score to improve breast cancer risk stratification, investigators in Finland used a nationwide genetic database to calculate polygenic risk score scores for 117,252 women and then linked the scores to their breast cancer outcomes, using the country’s nationwide mammography screening program, which screens women, ages 50-69 years, every 2 years.

The researchers evaluated the use of polygenic risk scores both alone and in combination with family histories and pathogenic variants — specifically, CHEK2 and PALB2 variants common in Finland.

The researchers also looked at how well polygenic risk scores predicted a person’s risk for any breast cancer as well as invasive, in situ, and bilateral at three timepoints: before, during, and after screening age.

TAKEAWAY:

Compared with a lower polygenic risk score (below 90%), a high polygenic risk score — a score in the top 10% — was associated with more than a twofold higher risk for any breast cancer before, during, and after screening age (hazard ratio [HR], 2.50, 2.38, and 2.11, respectively). Pathogenic variants and family histories led to similar risk assessments (HR, 3.13, 2.30, and 1.95, respectively, for pathogenic variants; HR, 1.97, 1.96, and 1.68, respectively, for family history).

A high polygenic risk score had a positive predictive value of 39.5% for a breast cancer diagnosis after a positive screening mammography, about the same as positive family history (35.5%) and pathogenic variants (35.9%). Combining a high polygenic risk score with a positive family history increased the positive predictive value to 44.6% and with pathogenic variant carriers increased the positive predictive value to 50.6%.

A high polygenic risk score was also associated with a twofold higher risk for interval breast cancer — a cancer diagnosed between screenings — and a higher risk for bilateral breast cancer during screening ages (HR, 4.71), suggesting that women with high scores may benefit from a shorter time interval between screenings or earlier screening, the researchers said.

Women with scores in the bottom 10% had a very low risk for both interval and screen-detected cancers. Those with negative family histories and no pathogenic variants did not reach the 2% cumulative incidence threshold for breast cancer screening until age 62 years, “suggesting opportunities for less frequent screens,” the researchers noted.

IN PRACTICE:

This study demonstrates the effectiveness of using a breast cancer polygenic risk score for risk stratification, “with optimal stratification reached through combining” this information with family history and pathogenic variants, the researchers concluded.

SOURCE:

The study, led by Nina Mars, MD, PhD, of the University of Helsinki, Helsinki, Finland, was published in the Journal of Clinical Oncology.

LIMITATIONS:

The work was limited largely to people with Finnish genetic ancestry. The benefits of including polygenic risk scores in screening programs need to be confirmed in clinical trials in areas with broader genetic ancestry; several trials are underway in the United States and elsewhere.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 research and innovation program, the Cancer Foundation Finland, and others. The investigators didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.