Women's Health

Black patients and those with public insurance are more likely than their White, wealthier counterparts to be screened for marijuana use during pregnancy, researchers have found.

The data build on a growing body of evidence that disparities in age, insurance type, and race affect which women undergo drug testing during pregnancy and come under scrutiny from state social service agencies.

Many states require health care facilities to notify child protective services or law enforcement of a positive drug screening, but the consequences for women vary greatly from state to state. Twenty-four states and the District of Columbia consider prenatal drug use to be child abuse. But recent evidence suggests that urine drug screenings may not be reliable but can lead to separation of parents and babies.

“In many ways, the health system is better equipped to address these concerns than the criminal justice system,” Rebecca Stone, PhD, associate professor of sociology and criminal justice at Suffolk University, Boston, told this news organization. “They shouldn’t be criminal justice problems in many cases,” added Dr. Stone, who was not involved with the study.

The researchers analyzed data from the 2,045 patients who gave birth between January and July 2020. Of those, roughly one-fourth (24%) underwent a urine drug screening. The most common reason for a screen was that clinicians either suspected or patients self-reported use of marijuana during or shortly before pregnancy, according to the researchers, who presented their findings at the American College of Obstetricians and Gynecologists (ACOG) 2022 Annual Meeting.

Nearly 80% of the 209 patients who underwent drug testing because of suspected marijuana use were Black, and nearly 61% had public insurance. The median age of persons who underwent drug testing was 25 years; the overall median age of pregnant patients was 29 years.

Of the 1,561 patients who didn’t undergo drug screening, 43% were Black, and 37% had public insurance coverage.

Clinicians reported that nearly all patients (117/125; 94%) who tested positive for marijuana were reported to the Missouri child abuse/neglect hotline. Only four women who tested positive for marijuana use also tested positive for at least one other illegal drug.

“Marijuana did not predict other drug exposure; thus, we suggest that a history of marijuana use should not be used as a criteria for sending a urine drug screen on patients [who are admitted to the labor unit],” said Jeannie Kelly, MD, medical director of maternal-fetal transport and labor and delivery at the Washington University School of Medicine, St. Louis, who is the senior author of the study. “In our experience, this is a policy that increases inequitable screening without improving our ability to identify families who need extra support or monitoring.”

All patients in the study verbally agreed to a urine drug screening. Hospitals around the country have faced lawsuits for failing to gain consent from women undergoing such tests. A 2001 ruling from the U.S. Supreme Court made informed consent mandatory in the absence of a warrant.
 

Legal consequences of a positive test

Children exposed to marijuana in the womb are at heightened risk for impaired cognition and learning disabilities, according to a 2015 report from ACOG’s Committee on Obstetric Practice. However, a lack of care before birth can be harmful to infants and result in low birth weight and severe neurologic and other problems.

In a 2015 study, Dr. Stone found that women were less likely to seek prenatal care if they worried about the legal consequences of a positive test.

Dr. Kelly said the threat of interference from child protective services is often the top worry of pregnant women with substance use disorders. She argued that clinicians should treat marijuana the same way they do tobacco: discourage its use without reporting patients to law enforcement.

“Our suggestion is that this history you elicit of someone using marijuana probably shouldn’t be used [as a trigger for drug screening],” Dr. Kelly said.

She added that doctors can use discretion in choosing to screen for drugs, and she urged clinicians and health care institutions to reevaluate their drug screening practices to reduce harm and increase equitable care.

“We can only work the system in the places that we have control over,” she said. “I can’t control the downward cascade, but I can definitely control who I send a urine drug screen on.”

Dr. Kelly and Dr. Stone reported no relevant financial relationships.

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

Black patients and those with public insurance are more likely than their White, wealthier counterparts to be screened for marijuana use during pregnancy, researchers have found.

The data build on a growing body of evidence that disparities in age, insurance type, and race affect which women undergo drug testing during pregnancy and come under scrutiny from state social service agencies.

Many states require health care facilities to notify child protective services or law enforcement of a positive drug screening, but the consequences for women vary greatly from state to state. Twenty-four states and the District of Columbia consider prenatal drug use to be child abuse. But recent evidence suggests that urine drug screenings may not be reliable but can lead to separation of parents and babies.

“In many ways, the health system is better equipped to address these concerns than the criminal justice system,” Rebecca Stone, PhD, associate professor of sociology and criminal justice at Suffolk University, Boston, told this news organization. “They shouldn’t be criminal justice problems in many cases,” added Dr. Stone, who was not involved with the study.

The researchers analyzed data from the 2,045 patients who gave birth between January and July 2020. Of those, roughly one-fourth (24%) underwent a urine drug screening. The most common reason for a screen was that clinicians either suspected or patients self-reported use of marijuana during or shortly before pregnancy, according to the researchers, who presented their findings at the American College of Obstetricians and Gynecologists (ACOG) 2022 Annual Meeting.

Nearly 80% of the 209 patients who underwent drug testing because of suspected marijuana use were Black, and nearly 61% had public insurance. The median age of persons who underwent drug testing was 25 years; the overall median age of pregnant patients was 29 years.

Of the 1,561 patients who didn’t undergo drug screening, 43% were Black, and 37% had public insurance coverage.

Clinicians reported that nearly all patients (117/125; 94%) who tested positive for marijuana were reported to the Missouri child abuse/neglect hotline. Only four women who tested positive for marijuana use also tested positive for at least one other illegal drug.

“Marijuana did not predict other drug exposure; thus, we suggest that a history of marijuana use should not be used as a criteria for sending a urine drug screen on patients [who are admitted to the labor unit],” said Jeannie Kelly, MD, medical director of maternal-fetal transport and labor and delivery at the Washington University School of Medicine, St. Louis, who is the senior author of the study. “In our experience, this is a policy that increases inequitable screening without improving our ability to identify families who need extra support or monitoring.”

All patients in the study verbally agreed to a urine drug screening. Hospitals around the country have faced lawsuits for failing to gain consent from women undergoing such tests. A 2001 ruling from the U.S. Supreme Court made informed consent mandatory in the absence of a warrant.
 

Legal consequences of a positive test

Children exposed to marijuana in the womb are at heightened risk for impaired cognition and learning disabilities, according to a 2015 report from ACOG’s Committee on Obstetric Practice. However, a lack of care before birth can be harmful to infants and result in low birth weight and severe neurologic and other problems.

In a 2015 study, Dr. Stone found that women were less likely to seek prenatal care if they worried about the legal consequences of a positive test.

Dr. Kelly said the threat of interference from child protective services is often the top worry of pregnant women with substance use disorders. She argued that clinicians should treat marijuana the same way they do tobacco: discourage its use without reporting patients to law enforcement.

“Our suggestion is that this history you elicit of someone using marijuana probably shouldn’t be used [as a trigger for drug screening],” Dr. Kelly said.

She added that doctors can use discretion in choosing to screen for drugs, and she urged clinicians and health care institutions to reevaluate their drug screening practices to reduce harm and increase equitable care.

“We can only work the system in the places that we have control over,” she said. “I can’t control the downward cascade, but I can definitely control who I send a urine drug screen on.”

Dr. Kelly and Dr. Stone reported no relevant financial relationships.

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

Black patients and those with public insurance are more likely than their White, wealthier counterparts to be screened for marijuana use during pregnancy, researchers have found.

The data build on a growing body of evidence that disparities in age, insurance type, and race affect which women undergo drug testing during pregnancy and come under scrutiny from state social service agencies.

Many states require health care facilities to notify child protective services or law enforcement of a positive drug screening, but the consequences for women vary greatly from state to state. Twenty-four states and the District of Columbia consider prenatal drug use to be child abuse. But recent evidence suggests that urine drug screenings may not be reliable but can lead to separation of parents and babies.

“In many ways, the health system is better equipped to address these concerns than the criminal justice system,” Rebecca Stone, PhD, associate professor of sociology and criminal justice at Suffolk University, Boston, told this news organization. “They shouldn’t be criminal justice problems in many cases,” added Dr. Stone, who was not involved with the study.

The researchers analyzed data from the 2,045 patients who gave birth between January and July 2020. Of those, roughly one-fourth (24%) underwent a urine drug screening. The most common reason for a screen was that clinicians either suspected or patients self-reported use of marijuana during or shortly before pregnancy, according to the researchers, who presented their findings at the American College of Obstetricians and Gynecologists (ACOG) 2022 Annual Meeting.

Nearly 80% of the 209 patients who underwent drug testing because of suspected marijuana use were Black, and nearly 61% had public insurance. The median age of persons who underwent drug testing was 25 years; the overall median age of pregnant patients was 29 years.

Of the 1,561 patients who didn’t undergo drug screening, 43% were Black, and 37% had public insurance coverage.

Clinicians reported that nearly all patients (117/125; 94%) who tested positive for marijuana were reported to the Missouri child abuse/neglect hotline. Only four women who tested positive for marijuana use also tested positive for at least one other illegal drug.

“Marijuana did not predict other drug exposure; thus, we suggest that a history of marijuana use should not be used as a criteria for sending a urine drug screen on patients [who are admitted to the labor unit],” said Jeannie Kelly, MD, medical director of maternal-fetal transport and labor and delivery at the Washington University School of Medicine, St. Louis, who is the senior author of the study. “In our experience, this is a policy that increases inequitable screening without improving our ability to identify families who need extra support or monitoring.”

All patients in the study verbally agreed to a urine drug screening. Hospitals around the country have faced lawsuits for failing to gain consent from women undergoing such tests. A 2001 ruling from the U.S. Supreme Court made informed consent mandatory in the absence of a warrant.
 

Legal consequences of a positive test

Children exposed to marijuana in the womb are at heightened risk for impaired cognition and learning disabilities, according to a 2015 report from ACOG’s Committee on Obstetric Practice. However, a lack of care before birth can be harmful to infants and result in low birth weight and severe neurologic and other problems.

In a 2015 study, Dr. Stone found that women were less likely to seek prenatal care if they worried about the legal consequences of a positive test.

Dr. Kelly said the threat of interference from child protective services is often the top worry of pregnant women with substance use disorders. She argued that clinicians should treat marijuana the same way they do tobacco: discourage its use without reporting patients to law enforcement.

“Our suggestion is that this history you elicit of someone using marijuana probably shouldn’t be used [as a trigger for drug screening],” Dr. Kelly said.

She added that doctors can use discretion in choosing to screen for drugs, and she urged clinicians and health care institutions to reevaluate their drug screening practices to reduce harm and increase equitable care.

“We can only work the system in the places that we have control over,” she said. “I can’t control the downward cascade, but I can definitely control who I send a urine drug screen on.”

Dr. Kelly and Dr. Stone reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

New phase 3 data support the use of the levonorgestrel 52-mg intrauterine device in nulliparous women with obesity and heavy menstrual bleeding. The findings, presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, showed a 97% reduction in blood loss 6 months after placement of the device, which is sold as the contraceptive Liletta by Medicines360 and AbbVie.

Experts say the results fill a gap in research because prior clinical trials of the IUD and a competitor, Mirena (Bayer), excluded significantly obese as well as nulliparous populations.

William Schlaff, MD, professor and chairman of the department of obstetrics & gynecology, Thomas Jefferson University, Philadelphia, said the absence of confirmatory evidence in these women has meant that, although use of the IUD has been “pretty widespread,” clinicians have been uncertain about the efficacy of the approach.

“Now we have objective data from a well-designed study that supports a practice that many of us have felt is probably a good one,” Dr. Schlaff, who was not involved in the new study, said in an interview.

Lead researcher Mitchell Creinin, MD, professor of obstetrics and gynecology at UC Davis Health, Sacramento, and colleagues at several centers across the country provided treatment with Liletta to 105 individuals with proven heavy menstrual bleeding. The patients’ median blood loss during two menses prior to placement of the device was 165 mL (range, 73-520 mL).

Participant demographics were: 65% White, 24% Black, 10% Hispanic, 4% Asian, and 7% who identified with other racial groups. Mean body mass index was 30.9 kg/m², and 45% of individuals met the criteria for obesity (BMI > 30), including 13% who had a BMI of at least 40. Nearly 30% of participants in the study had never given birth and none had known medical, anatomic, infectious, or neoplastic causes of bleeding.

According to Dr. Creinin, 86 women were assessed 3 months after device placement, and their median blood loss at the time was 9.5 mL (interquartile range, 2.5-22.9 mL), representing a median 93% decrease from baseline. Median blood loss 6 months after placement of the IUD was 3.8 mL (IQR, 0-10.1 mL), a 97% reduction from baseline.

Regardless of parity or BMI, blood loss at 6 months was 97%-97.5% lower than baseline, Dr. Creinin reported.

Among the 23% of participants who did not complete the study, 4% experienced expulsions of the device, which Dr. Creinin said is a rate twice as high as that seen in women using hormone-releasing IUDs for contraception. However, he said it “is consistent with other studies among patients with quantitatively proven heavy menstrual bleeding.”

Another 6% of women who did not complete the study removed the device owing to bleeding and cramping complaints, 9% were lost to follow-up or withdrew consent, and 5% discontinued treatment for unspecified reasons, Dr. Creinin said.

“Etiologies for heavy menstrual bleeding may be different in the individuals we studied, so our findings provide assurance that these populations with heavy menstrual bleeding are equally well treated” with the IUD, Dr. Creinin said.

Dr. Creinin reported study funding from Medicines360. Dr. Schlaff reported no financial conflicts of interest.

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

New phase 3 data support the use of the levonorgestrel 52-mg intrauterine device in nulliparous women with obesity and heavy menstrual bleeding. The findings, presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, showed a 97% reduction in blood loss 6 months after placement of the device, which is sold as the contraceptive Liletta by Medicines360 and AbbVie.

Experts say the results fill a gap in research because prior clinical trials of the IUD and a competitor, Mirena (Bayer), excluded significantly obese as well as nulliparous populations.

William Schlaff, MD, professor and chairman of the department of obstetrics & gynecology, Thomas Jefferson University, Philadelphia, said the absence of confirmatory evidence in these women has meant that, although use of the IUD has been “pretty widespread,” clinicians have been uncertain about the efficacy of the approach.

“Now we have objective data from a well-designed study that supports a practice that many of us have felt is probably a good one,” Dr. Schlaff, who was not involved in the new study, said in an interview.

Lead researcher Mitchell Creinin, MD, professor of obstetrics and gynecology at UC Davis Health, Sacramento, and colleagues at several centers across the country provided treatment with Liletta to 105 individuals with proven heavy menstrual bleeding. The patients’ median blood loss during two menses prior to placement of the device was 165 mL (range, 73-520 mL).

Participant demographics were: 65% White, 24% Black, 10% Hispanic, 4% Asian, and 7% who identified with other racial groups. Mean body mass index was 30.9 kg/m², and 45% of individuals met the criteria for obesity (BMI > 30), including 13% who had a BMI of at least 40. Nearly 30% of participants in the study had never given birth and none had known medical, anatomic, infectious, or neoplastic causes of bleeding.

According to Dr. Creinin, 86 women were assessed 3 months after device placement, and their median blood loss at the time was 9.5 mL (interquartile range, 2.5-22.9 mL), representing a median 93% decrease from baseline. Median blood loss 6 months after placement of the IUD was 3.8 mL (IQR, 0-10.1 mL), a 97% reduction from baseline.

Regardless of parity or BMI, blood loss at 6 months was 97%-97.5% lower than baseline, Dr. Creinin reported.

Among the 23% of participants who did not complete the study, 4% experienced expulsions of the device, which Dr. Creinin said is a rate twice as high as that seen in women using hormone-releasing IUDs for contraception. However, he said it “is consistent with other studies among patients with quantitatively proven heavy menstrual bleeding.”

Another 6% of women who did not complete the study removed the device owing to bleeding and cramping complaints, 9% were lost to follow-up or withdrew consent, and 5% discontinued treatment for unspecified reasons, Dr. Creinin said.

“Etiologies for heavy menstrual bleeding may be different in the individuals we studied, so our findings provide assurance that these populations with heavy menstrual bleeding are equally well treated” with the IUD, Dr. Creinin said.

Dr. Creinin reported study funding from Medicines360. Dr. Schlaff reported no financial conflicts of interest.

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

New phase 3 data support the use of the levonorgestrel 52-mg intrauterine device in nulliparous women with obesity and heavy menstrual bleeding. The findings, presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, showed a 97% reduction in blood loss 6 months after placement of the device, which is sold as the contraceptive Liletta by Medicines360 and AbbVie.

Experts say the results fill a gap in research because prior clinical trials of the IUD and a competitor, Mirena (Bayer), excluded significantly obese as well as nulliparous populations.

William Schlaff, MD, professor and chairman of the department of obstetrics & gynecology, Thomas Jefferson University, Philadelphia, said the absence of confirmatory evidence in these women has meant that, although use of the IUD has been “pretty widespread,” clinicians have been uncertain about the efficacy of the approach.

“Now we have objective data from a well-designed study that supports a practice that many of us have felt is probably a good one,” Dr. Schlaff, who was not involved in the new study, said in an interview.

Lead researcher Mitchell Creinin, MD, professor of obstetrics and gynecology at UC Davis Health, Sacramento, and colleagues at several centers across the country provided treatment with Liletta to 105 individuals with proven heavy menstrual bleeding. The patients’ median blood loss during two menses prior to placement of the device was 165 mL (range, 73-520 mL).

Participant demographics were: 65% White, 24% Black, 10% Hispanic, 4% Asian, and 7% who identified with other racial groups. Mean body mass index was 30.9 kg/m², and 45% of individuals met the criteria for obesity (BMI > 30), including 13% who had a BMI of at least 40. Nearly 30% of participants in the study had never given birth and none had known medical, anatomic, infectious, or neoplastic causes of bleeding.

According to Dr. Creinin, 86 women were assessed 3 months after device placement, and their median blood loss at the time was 9.5 mL (interquartile range, 2.5-22.9 mL), representing a median 93% decrease from baseline. Median blood loss 6 months after placement of the IUD was 3.8 mL (IQR, 0-10.1 mL), a 97% reduction from baseline.

Regardless of parity or BMI, blood loss at 6 months was 97%-97.5% lower than baseline, Dr. Creinin reported.

Among the 23% of participants who did not complete the study, 4% experienced expulsions of the device, which Dr. Creinin said is a rate twice as high as that seen in women using hormone-releasing IUDs for contraception. However, he said it “is consistent with other studies among patients with quantitatively proven heavy menstrual bleeding.”

Another 6% of women who did not complete the study removed the device owing to bleeding and cramping complaints, 9% were lost to follow-up or withdrew consent, and 5% discontinued treatment for unspecified reasons, Dr. Creinin said.

“Etiologies for heavy menstrual bleeding may be different in the individuals we studied, so our findings provide assurance that these populations with heavy menstrual bleeding are equally well treated” with the IUD, Dr. Creinin said.

Dr. Creinin reported study funding from Medicines360. Dr. Schlaff reported no financial conflicts of interest.

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

When Stephanie Mejia Arciñiega drove her friend to a Planned Parenthood clinic in Ann Arbor, Mich., they were surrounded by anti-abortion protesters as soon as they tried to park.

“They come up to your car super fast,” Ms. Mejia Arciñiega said. “You don’t want to run their feet over, so we had to stop and be like, ‘OK, no thank you.’ But then they started throwing a bunch of papers and resources at us. We tried to go inside, but we couldn’t.”

The clinic, which offers abortion care as well as birth control, cancer screenings, and STD treatment, has long been the target of anti-abortion protesters. Protesters’ efforts to limit abortions in the state may soon get a huge boost, if the Supreme Court strikes down Roe v. Wade.

In Michigan, this would have an immediate impact. Overnight, nearly all abortions would become a felony carrying a penalty of up to 4 years, even in cases of rape and incest. That’s because an old state law, last updated in 1931, was never repealed, even after Roe made it unenforceable in 1973.

Michigan Attorney General Dana Nessel, a Democrat, said she won’t enforce the law if it springs back into effect. But Michigan has 83 local county prosecutors, and Ms. Nessel said they could enforce the 1931 law. “I don’t think that I have the authority to tell the duly elected county prosecutors what they can and what they cannot charge,” Ms. Nessel told journalists.

Ms. Mejia Arciñiega, 18, who drove her friend to the Ann Arbor clinic, said she never imagined a world where abortion is illegal. “You wouldn’t think that in 2022, we’d be worrying about women’s rights, reproduction rights,” she said. “You wouldn’t want someone young that isn’t ready [to] have to have a baby because the law says ‘No.’ It’s not fair.”

The way the old state law is written, Ms. Nessel said, it’s possible that prosecutors could go after anyone who provides an abortion, as well as those who take medications to end their own pregnancies.

That could “create a scenario where if a woman has self-aborted and she seeks medical care after that, will the doctor then have to report that to law enforcement?”

Speaking to reporters, Ms. Nessel also discussed the abortion she had years ago – one that would be illegal in the state if Roe falls. She was pregnant with triplets and doctors told her the embryos weren’t growing in utero, she said.

“And I was told very, very specifically that there was no way that all three would make it to term. But if I aborted one, that it was possible that the other two might live,” Ms. Nessel said. “I took my doctor’s advice … And you know what? It turned out that he was right. And now I have two beautiful sons.”

The 1931 law allows just one exemption: Abortions “to preserve the life” of the woman. Yet doctors say they have no idea how to interpret that. Consider a woman who has severe heart disease with a 20%-30% chance of dying during pregnancy.

“Is that enough of a chance?” asked Dr. Lisa Harris, a University of Michigan professor and ob.gyn., speaking on Michigan Radio’s Stateside. “I hate to even put it that way, but is that enough of a chance of dying that that person would qualify under Michigan’s ban for a lifesaving abortion? Or would their risk of dying need to be 50% or 100%?”

Or what if a pregnant person has cancer and needs to end the pregnancy to begin chemotherapy? “There’s not an imminent risk of dying, but there might be a risk of dying years later if they didn’t have chemotherapy,” Dr. Harris said. “So these are the kind of situations doctors are wondering about.”

It’s also unclear whether a woman whose pregnancy would become life-threatening only in its later stages would be required to delay termination until then.

“We see people with things like kidney disease or other problems, where they’re actually OK during early pregnancy. But if the pregnancy were to continue and they were to give birth, then they would have a very high chance of dying,” Dr. Harris explained.

The state legislature is controlled by Republicans, but Michigan Gov. Gretchen Whitmer, a Democrat, filed a preemptive lawsuit seeking to block the 1931 law from taking effect. Planned Parenthood filed a similar suit as well. And a campaign to collect enough signatures is underway to put abortion on the ballot in November. But that would be months after the U.S. Supreme Court makes its final ruling on Roe, which is expected in late June or early July.

In the meantime, the confusion and uncertainty caused by the 1931 law could be enough for some health care professionals to stop offering abortions, Ms. Nessel said.

“I think that this will have the kind of chilling effect that doctors just simply will not perform this procedure really under any set of circumstances, because they don’t want to get dragged into court,” she said. “They don’t want to face the possibility of being prosecuted and the possibility of going to jail or prison. So I think that, honestly, you’ll have doctors that really have to violate their Hippocratic oath and just say, ‘I’m sorry, I can’t help you.’ ”

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

When Stephanie Mejia Arciñiega drove her friend to a Planned Parenthood clinic in Ann Arbor, Mich., they were surrounded by anti-abortion protesters as soon as they tried to park.

“They come up to your car super fast,” Ms. Mejia Arciñiega said. “You don’t want to run their feet over, so we had to stop and be like, ‘OK, no thank you.’ But then they started throwing a bunch of papers and resources at us. We tried to go inside, but we couldn’t.”

The clinic, which offers abortion care as well as birth control, cancer screenings, and STD treatment, has long been the target of anti-abortion protesters. Protesters’ efforts to limit abortions in the state may soon get a huge boost, if the Supreme Court strikes down Roe v. Wade.

In Michigan, this would have an immediate impact. Overnight, nearly all abortions would become a felony carrying a penalty of up to 4 years, even in cases of rape and incest. That’s because an old state law, last updated in 1931, was never repealed, even after Roe made it unenforceable in 1973.

Michigan Attorney General Dana Nessel, a Democrat, said she won’t enforce the law if it springs back into effect. But Michigan has 83 local county prosecutors, and Ms. Nessel said they could enforce the 1931 law. “I don’t think that I have the authority to tell the duly elected county prosecutors what they can and what they cannot charge,” Ms. Nessel told journalists.

Ms. Mejia Arciñiega, 18, who drove her friend to the Ann Arbor clinic, said she never imagined a world where abortion is illegal. “You wouldn’t think that in 2022, we’d be worrying about women’s rights, reproduction rights,” she said. “You wouldn’t want someone young that isn’t ready [to] have to have a baby because the law says ‘No.’ It’s not fair.”

The way the old state law is written, Ms. Nessel said, it’s possible that prosecutors could go after anyone who provides an abortion, as well as those who take medications to end their own pregnancies.

That could “create a scenario where if a woman has self-aborted and she seeks medical care after that, will the doctor then have to report that to law enforcement?”

Speaking to reporters, Ms. Nessel also discussed the abortion she had years ago – one that would be illegal in the state if Roe falls. She was pregnant with triplets and doctors told her the embryos weren’t growing in utero, she said.

“And I was told very, very specifically that there was no way that all three would make it to term. But if I aborted one, that it was possible that the other two might live,” Ms. Nessel said. “I took my doctor’s advice … And you know what? It turned out that he was right. And now I have two beautiful sons.”

The 1931 law allows just one exemption: Abortions “to preserve the life” of the woman. Yet doctors say they have no idea how to interpret that. Consider a woman who has severe heart disease with a 20%-30% chance of dying during pregnancy.

“Is that enough of a chance?” asked Dr. Lisa Harris, a University of Michigan professor and ob.gyn., speaking on Michigan Radio’s Stateside. “I hate to even put it that way, but is that enough of a chance of dying that that person would qualify under Michigan’s ban for a lifesaving abortion? Or would their risk of dying need to be 50% or 100%?”

Or what if a pregnant person has cancer and needs to end the pregnancy to begin chemotherapy? “There’s not an imminent risk of dying, but there might be a risk of dying years later if they didn’t have chemotherapy,” Dr. Harris said. “So these are the kind of situations doctors are wondering about.”

It’s also unclear whether a woman whose pregnancy would become life-threatening only in its later stages would be required to delay termination until then.

“We see people with things like kidney disease or other problems, where they’re actually OK during early pregnancy. But if the pregnancy were to continue and they were to give birth, then they would have a very high chance of dying,” Dr. Harris explained.

The state legislature is controlled by Republicans, but Michigan Gov. Gretchen Whitmer, a Democrat, filed a preemptive lawsuit seeking to block the 1931 law from taking effect. Planned Parenthood filed a similar suit as well. And a campaign to collect enough signatures is underway to put abortion on the ballot in November. But that would be months after the U.S. Supreme Court makes its final ruling on Roe, which is expected in late June or early July.

In the meantime, the confusion and uncertainty caused by the 1931 law could be enough for some health care professionals to stop offering abortions, Ms. Nessel said.

“I think that this will have the kind of chilling effect that doctors just simply will not perform this procedure really under any set of circumstances, because they don’t want to get dragged into court,” she said. “They don’t want to face the possibility of being prosecuted and the possibility of going to jail or prison. So I think that, honestly, you’ll have doctors that really have to violate their Hippocratic oath and just say, ‘I’m sorry, I can’t help you.’ ”

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

When Stephanie Mejia Arciñiega drove her friend to a Planned Parenthood clinic in Ann Arbor, Mich., they were surrounded by anti-abortion protesters as soon as they tried to park.

“They come up to your car super fast,” Ms. Mejia Arciñiega said. “You don’t want to run their feet over, so we had to stop and be like, ‘OK, no thank you.’ But then they started throwing a bunch of papers and resources at us. We tried to go inside, but we couldn’t.”

The clinic, which offers abortion care as well as birth control, cancer screenings, and STD treatment, has long been the target of anti-abortion protesters. Protesters’ efforts to limit abortions in the state may soon get a huge boost, if the Supreme Court strikes down Roe v. Wade.

In Michigan, this would have an immediate impact. Overnight, nearly all abortions would become a felony carrying a penalty of up to 4 years, even in cases of rape and incest. That’s because an old state law, last updated in 1931, was never repealed, even after Roe made it unenforceable in 1973.

Michigan Attorney General Dana Nessel, a Democrat, said she won’t enforce the law if it springs back into effect. But Michigan has 83 local county prosecutors, and Ms. Nessel said they could enforce the 1931 law. “I don’t think that I have the authority to tell the duly elected county prosecutors what they can and what they cannot charge,” Ms. Nessel told journalists.

Ms. Mejia Arciñiega, 18, who drove her friend to the Ann Arbor clinic, said she never imagined a world where abortion is illegal. “You wouldn’t think that in 2022, we’d be worrying about women’s rights, reproduction rights,” she said. “You wouldn’t want someone young that isn’t ready [to] have to have a baby because the law says ‘No.’ It’s not fair.”

The way the old state law is written, Ms. Nessel said, it’s possible that prosecutors could go after anyone who provides an abortion, as well as those who take medications to end their own pregnancies.

That could “create a scenario where if a woman has self-aborted and she seeks medical care after that, will the doctor then have to report that to law enforcement?”

Speaking to reporters, Ms. Nessel also discussed the abortion she had years ago – one that would be illegal in the state if Roe falls. She was pregnant with triplets and doctors told her the embryos weren’t growing in utero, she said.

“And I was told very, very specifically that there was no way that all three would make it to term. But if I aborted one, that it was possible that the other two might live,” Ms. Nessel said. “I took my doctor’s advice … And you know what? It turned out that he was right. And now I have two beautiful sons.”

The 1931 law allows just one exemption: Abortions “to preserve the life” of the woman. Yet doctors say they have no idea how to interpret that. Consider a woman who has severe heart disease with a 20%-30% chance of dying during pregnancy.

“Is that enough of a chance?” asked Dr. Lisa Harris, a University of Michigan professor and ob.gyn., speaking on Michigan Radio’s Stateside. “I hate to even put it that way, but is that enough of a chance of dying that that person would qualify under Michigan’s ban for a lifesaving abortion? Or would their risk of dying need to be 50% or 100%?”

Or what if a pregnant person has cancer and needs to end the pregnancy to begin chemotherapy? “There’s not an imminent risk of dying, but there might be a risk of dying years later if they didn’t have chemotherapy,” Dr. Harris said. “So these are the kind of situations doctors are wondering about.”

It’s also unclear whether a woman whose pregnancy would become life-threatening only in its later stages would be required to delay termination until then.

“We see people with things like kidney disease or other problems, where they’re actually OK during early pregnancy. But if the pregnancy were to continue and they were to give birth, then they would have a very high chance of dying,” Dr. Harris explained.

The state legislature is controlled by Republicans, but Michigan Gov. Gretchen Whitmer, a Democrat, filed a preemptive lawsuit seeking to block the 1931 law from taking effect. Planned Parenthood filed a similar suit as well. And a campaign to collect enough signatures is underway to put abortion on the ballot in November. But that would be months after the U.S. Supreme Court makes its final ruling on Roe, which is expected in late June or early July.

In the meantime, the confusion and uncertainty caused by the 1931 law could be enough for some health care professionals to stop offering abortions, Ms. Nessel said.

“I think that this will have the kind of chilling effect that doctors just simply will not perform this procedure really under any set of circumstances, because they don’t want to get dragged into court,” she said. “They don’t want to face the possibility of being prosecuted and the possibility of going to jail or prison. So I think that, honestly, you’ll have doctors that really have to violate their Hippocratic oath and just say, ‘I’m sorry, I can’t help you.’ ”

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

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.