Women's Health

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

flocu/ThinkStock

There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

flocu/ThinkStock

There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

flocu/ThinkStock

There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.

The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.

In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.

The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.

[email protected]

The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.

In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.

The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.

[email protected]

The Food and Drug Administration has approved marketing of the first medical mobile application that can be used as a contraceptive, the agency announced in a written statement.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The app, called Natural Cycles, contains an algorithm that calculates the days of the month women are likely to be fertile, based on daily body temperature readings and menstrual cycle information, and is intended for premenopausal women aged 18 years and older. App users are instructed to take their daily body temperatures with a basal body thermometer and enter the information into the app. The more-sensitive basal body thermometer can detect temperature elevations during ovulation, and the app will display a warning on days when users are most fertile. During these days, women should either abstain from sex or use protection.

In clinical studies comprising more than 15,000 women, Natural Cycles had a “perfect use” failure rate of 1.8% and a “normal use” failure rate of 6.5%. This compares favorably with other forms of contraception and birth control: Male condoms have a perfect use failure rate of 2.0% and a normal use failure rate of 18.0%, and combined oral contraceptives have a perfect use failure rate of 0.3% and a normal use failure rate of 9.0%, according to the Association of Reproductive Care Professionals.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in the statement.

The app should not be used by women with a condition in which a pregnancy would present risk to the mother or fetus or by women who are using a birth control or hormonal treatment that inhibits ovulation. Natural Cycles does not protect against sexually transmitted infections.

[email protected]

The prevalence of opioid use disorder more than quadrupled among pregnant women at labor and delivery from 1999 to 2014, according to the Centers for Disease Control and Prevention.

The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.

Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.

Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”

“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”

Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.

[email protected]

SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.

The prevalence of opioid use disorder more than quadrupled among pregnant women at labor and delivery from 1999 to 2014, according to the Centers for Disease Control and Prevention.

The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.

Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.

Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”

“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”

Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.

[email protected]

SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.

The prevalence of opioid use disorder more than quadrupled among pregnant women at labor and delivery from 1999 to 2014, according to the Centers for Disease Control and Prevention.

The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.

Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.

Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”

“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”

Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.

[email protected]

SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.

Nulliparous women who were induced at 39 weeks had the same relative risk of adverse perinatal outcomes but a lower risk of a cesarean delivery, compared with women who received expectant management, results that researchers say contrast traditional recommendations for perinatal care, according to study from the New England Journal of Medicine.

Michele G. Sullivan/Frontline Medical News

“These findings contradict the conclusions of multiple observational studies that have suggested that labor induction is associated with an increased risk of adverse maternal and perinatal outcomes,” William A. Grobman, MD, the Arthur Hale Curtis, MD, Professor of Obstetrics and Gynecology at Northwestern University in Chicago, and his colleagues wrote. “These studies, however, compared women who underwent labor induction with those who had spontaneous labor, which is not a comparison that is useful to guide clinical decision making.”

Dr. Grobman and his colleagues evaluated the deliveries of 3,062 women who underwent labor induction between 39 weeks of gestation and 39 weeks and 4 days of gestation, and compared them with outcomes of 3,044 women who received expectant management until 40 weeks and 5 days of gestation. Women in both groups had a singleton fetus, no indication of early delivery, and did not plan on delivering by C-section. The participants were assessed again at about 38 weeks of gestation and randomly assigned to receive labor induction or expectant management as part of a multicenter randomized, controlled, parallel-group, unmasked trial in 41 maternal-fetal medicine departments in hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development network screened between March 2014, and August 2017.

Primary perinatal outcomes and components were defined as perinatal death, respiratory support, an Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension that requires vasopressor support. The principal secondary outcome was cesarean delivery, but other secondary outcomes included neonatal or intensive care, infection, postpartum hospital stay, and hypertension, among others.

Dr. Grobman and his colleagues found 132 (4.3%) of neonates in the induction group and 164 (5.4%) in the expectant-management group experienced a primary composite outcome (relative risk, 0.80; 95% confidence interval, 0.64-1.00; P = .049).

Regarding secondary outcomes, there was a significantly lower risk of cesarean delivery in the induction group, with 18.6% of women undergoing a cesarean delivery, compared with 22.2% of women in the expectant-management group (RR, 0.84; 95% CI, 0.76-0.93; P less than .001). Women in the labor induction group had a significantly lower relative risk of hypertensive disorders of pregnancy (9.1%), compared with the expectant-management (14.1%) group (RR, 0.64; 95% CI, 0.56-0.74; P less than .001). The investigators said women who underwent induced labor had lower 10-point Likert scale scores, were more likely to have “extensions of the uterine incision during cesarean delivery,” perceived they had “more control” during delivery, and had a shorter postpartum stay in the hospital, compared with women who received expectant management. However, women in the induced labor group also had a longer stay in the labor and delivery units, they said.

The researchers noted the limitations in this study, which included its unmasked design, lack of power to detect infrequent outcome differences, and the lack of information surrounding labor induction at 39 weeks in low-risk nulliparous women.

“These results suggest that policies aimed at the avoidance of elective labor induction among low-risk nulliparous women at 39 weeks of gestation are unlikely to reduce the rate of cesarean delivery on a population level; the trial provides information that can be incorporated into discussions that rely on principles of shared decision making,” Dr. Grobman and his colleagues wrote.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Silver reports receiving personal fees from Gestavision. The other authors report no relevant financial disclosures.

SOURCE: Grobman WA et al. N Engl J Med. 2018 Aug 9. doi: 10.1056/NEJMoa1800566.

Nulliparous women who were induced at 39 weeks had the same relative risk of adverse perinatal outcomes but a lower risk of a cesarean delivery, compared with women who received expectant management, results that researchers say contrast traditional recommendations for perinatal care, according to study from the New England Journal of Medicine.

Michele G. Sullivan/Frontline Medical News

“These findings contradict the conclusions of multiple observational studies that have suggested that labor induction is associated with an increased risk of adverse maternal and perinatal outcomes,” William A. Grobman, MD, the Arthur Hale Curtis, MD, Professor of Obstetrics and Gynecology at Northwestern University in Chicago, and his colleagues wrote. “These studies, however, compared women who underwent labor induction with those who had spontaneous labor, which is not a comparison that is useful to guide clinical decision making.”

Dr. Grobman and his colleagues evaluated the deliveries of 3,062 women who underwent labor induction between 39 weeks of gestation and 39 weeks and 4 days of gestation, and compared them with outcomes of 3,044 women who received expectant management until 40 weeks and 5 days of gestation. Women in both groups had a singleton fetus, no indication of early delivery, and did not plan on delivering by C-section. The participants were assessed again at about 38 weeks of gestation and randomly assigned to receive labor induction or expectant management as part of a multicenter randomized, controlled, parallel-group, unmasked trial in 41 maternal-fetal medicine departments in hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development network screened between March 2014, and August 2017.

Primary perinatal outcomes and components were defined as perinatal death, respiratory support, an Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension that requires vasopressor support. The principal secondary outcome was cesarean delivery, but other secondary outcomes included neonatal or intensive care, infection, postpartum hospital stay, and hypertension, among others.

Dr. Grobman and his colleagues found 132 (4.3%) of neonates in the induction group and 164 (5.4%) in the expectant-management group experienced a primary composite outcome (relative risk, 0.80; 95% confidence interval, 0.64-1.00; P = .049).

Regarding secondary outcomes, there was a significantly lower risk of cesarean delivery in the induction group, with 18.6% of women undergoing a cesarean delivery, compared with 22.2% of women in the expectant-management group (RR, 0.84; 95% CI, 0.76-0.93; P less than .001). Women in the labor induction group had a significantly lower relative risk of hypertensive disorders of pregnancy (9.1%), compared with the expectant-management (14.1%) group (RR, 0.64; 95% CI, 0.56-0.74; P less than .001). The investigators said women who underwent induced labor had lower 10-point Likert scale scores, were more likely to have “extensions of the uterine incision during cesarean delivery,” perceived they had “more control” during delivery, and had a shorter postpartum stay in the hospital, compared with women who received expectant management. However, women in the induced labor group also had a longer stay in the labor and delivery units, they said.

The researchers noted the limitations in this study, which included its unmasked design, lack of power to detect infrequent outcome differences, and the lack of information surrounding labor induction at 39 weeks in low-risk nulliparous women.

“These results suggest that policies aimed at the avoidance of elective labor induction among low-risk nulliparous women at 39 weeks of gestation are unlikely to reduce the rate of cesarean delivery on a population level; the trial provides information that can be incorporated into discussions that rely on principles of shared decision making,” Dr. Grobman and his colleagues wrote.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Silver reports receiving personal fees from Gestavision. The other authors report no relevant financial disclosures.

SOURCE: Grobman WA et al. N Engl J Med. 2018 Aug 9. doi: 10.1056/NEJMoa1800566.

Nulliparous women who were induced at 39 weeks had the same relative risk of adverse perinatal outcomes but a lower risk of a cesarean delivery, compared with women who received expectant management, results that researchers say contrast traditional recommendations for perinatal care, according to study from the New England Journal of Medicine.

Michele G. Sullivan/Frontline Medical News

“These findings contradict the conclusions of multiple observational studies that have suggested that labor induction is associated with an increased risk of adverse maternal and perinatal outcomes,” William A. Grobman, MD, the Arthur Hale Curtis, MD, Professor of Obstetrics and Gynecology at Northwestern University in Chicago, and his colleagues wrote. “These studies, however, compared women who underwent labor induction with those who had spontaneous labor, which is not a comparison that is useful to guide clinical decision making.”

Dr. Grobman and his colleagues evaluated the deliveries of 3,062 women who underwent labor induction between 39 weeks of gestation and 39 weeks and 4 days of gestation, and compared them with outcomes of 3,044 women who received expectant management until 40 weeks and 5 days of gestation. Women in both groups had a singleton fetus, no indication of early delivery, and did not plan on delivering by C-section. The participants were assessed again at about 38 weeks of gestation and randomly assigned to receive labor induction or expectant management as part of a multicenter randomized, controlled, parallel-group, unmasked trial in 41 maternal-fetal medicine departments in hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development network screened between March 2014, and August 2017.

Primary perinatal outcomes and components were defined as perinatal death, respiratory support, an Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension that requires vasopressor support. The principal secondary outcome was cesarean delivery, but other secondary outcomes included neonatal or intensive care, infection, postpartum hospital stay, and hypertension, among others.

Dr. Grobman and his colleagues found 132 (4.3%) of neonates in the induction group and 164 (5.4%) in the expectant-management group experienced a primary composite outcome (relative risk, 0.80; 95% confidence interval, 0.64-1.00; P = .049).

Regarding secondary outcomes, there was a significantly lower risk of cesarean delivery in the induction group, with 18.6% of women undergoing a cesarean delivery, compared with 22.2% of women in the expectant-management group (RR, 0.84; 95% CI, 0.76-0.93; P less than .001). Women in the labor induction group had a significantly lower relative risk of hypertensive disorders of pregnancy (9.1%), compared with the expectant-management (14.1%) group (RR, 0.64; 95% CI, 0.56-0.74; P less than .001). The investigators said women who underwent induced labor had lower 10-point Likert scale scores, were more likely to have “extensions of the uterine incision during cesarean delivery,” perceived they had “more control” during delivery, and had a shorter postpartum stay in the hospital, compared with women who received expectant management. However, women in the induced labor group also had a longer stay in the labor and delivery units, they said.

The researchers noted the limitations in this study, which included its unmasked design, lack of power to detect infrequent outcome differences, and the lack of information surrounding labor induction at 39 weeks in low-risk nulliparous women.

“These results suggest that policies aimed at the avoidance of elective labor induction among low-risk nulliparous women at 39 weeks of gestation are unlikely to reduce the rate of cesarean delivery on a population level; the trial provides information that can be incorporated into discussions that rely on principles of shared decision making,” Dr. Grobman and his colleagues wrote.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Silver reports receiving personal fees from Gestavision. The other authors report no relevant financial disclosures.

SOURCE: Grobman WA et al. N Engl J Med. 2018 Aug 9. doi: 10.1056/NEJMoa1800566.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

[email protected]

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

[email protected]

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

[email protected]

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.

About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.

Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.

In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).

“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”

USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.

In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.

Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.

Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”

Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”

Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.

Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.

The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.

CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.

Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.

“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”

[email protected]

SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.

About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.

Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.

In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).

“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”

USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.

In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.

Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.

Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”

Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”

Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.

Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.

The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.

CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.

Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.

“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”

[email protected]

SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.

About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.

Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.

In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).

“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”

USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.

In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.

Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.

Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”

Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”

Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.

Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.

The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.

CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.

Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.

“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”

[email protected]

SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.

The Food and Drug Administration has issued a stern warning to several manufacturers and a statement of caution to the public concerning “vaginal rejuvenation,” an umbrella term for a host of procedures to alter vaginal tissue for therapeutic or cosmetic purposes.

Lasers and other energy-based devices have been approved to treat abnormal or precancerous cervical or vaginal tissue and general warts, but the FDA has not approved any to treat vaginal atrophy, urinary incontinence, or reduced sexual function.

Device manufacturers claim lasers can address these conditions despite limited scientific evidence for their safety or efficacy. Insurers do not reimburse the procedures, considering them to be cosmetic.

In a July 30 statement, FDA Commissioner Scott Gottlieb, MD, slammed “deceptive” marketing practices on the part of manufacturers.

The FDA has reviewed 12 complaints since December 2015 of adverse effects related to vaginal procedures using the devices. Two were from manufacturers reporting pain and bleeding in patients following treatment, FDA spokeswoman Deborah Kotz said in an interview. “The FDA has also received voluntary MedWatch reports from individual patients who experienced significant pain and discomfort from procedures performed with these devices.”

The agency has targeted seven firms: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and ThermiGen, with letters demanding evidence of FDA approval, clearance, or intent to seek clearance for use of their products on female genitalia. They also asked for evidence backing specific claims.

In a July 26 letter to BTL Industries, for example, the FDA demanded to know why the firm was marketing its Exilis laser device, approved for the treatment of facial wrinkles, as “Ultra Femme 360,” which it called “a whole new approach to women’s intimate health.” The device, according to the manufacturer, “provides the shortest noninvasive radio-frequency treatment available for female intimate parts” and “is proven to increase elastin and collagen in the treatment area.”

The FDA asked Cynosure, the maker of the Mona Lisa Touch, a system marketed as an FDA-approved treatment for vaginal atrophy, for evidence to support its claims that Mona Lisa Touch “is the only technology for vaginal and vulvar health with over 18+ published clinical studies” and is clinically proven to treat “painful symptoms of menopause, including intimacy.” They also asked for information about a modification to the originally approved device that was not brought to the FDA’s attention.

In a letter to Alma Lasers, whose Pixel CO₂ Laser System was approved for use in a broad use of surgical applications including gynecologic surgery, the FDA noted that the device was being marketed as “FEMILIFT,” a laser procedure designed to “improve vaginal irregularities” and to assist “in vaginal mucosa revitalization.” The FDA demanded evidence for those claims.

The manufacturers have 30 days to respond to the FDA, which has not ruled out seeking enforcement action against firms with unsatisfactory responses.

For more than a decade, researchers have shown that healthy vaginal morphology is exceptionally wide ranging, including a recent study in more than 650 women, the largest to date (BJOG. 2018 Jun 25. doi: 10.1111/1471-0528.15387). Nonetheless, interest in elective vaginal procedures has only increased, with an industry report from the International Society of Aesthetic and Plastic Surgery describing a 45% increase in the use of one surgery, vaginal labiaplasty, between 2014 and 2016. Most procedures were performed in Brazil and the United States.

While plastic surgery societies support vaginal rejuvenation procedures, the American College of Obstetricians and Gynecologists has long frowned on them, with its first critique issued in a 2007 committee opinion. “No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures,” the association said last year in its most recent update on the subject.

Gynecologist David M. Jaspan, DO, of the Einstein Healthcare Network in Philadelphia, echoed ACOG’s views and said he welcomed FDA interest in vaginal rejuvenation.

The practice has “never been endorsed by the College or a board. It’s been considered a cosmetic procedure and it’s been under scrutiny for at least a decade,” Dr. Jaspan said. “I have reservations about the clinical outcomes and the training surrounds these procedures and I anxiously await randomized controlled trials to further evaluate them.”

Gynecologists who offer the procedures caution that they may have a role, and that randomized trials are underway to determine which groups of women might be best helped.

Marie Paraiso, MD, professor of obstetrics and gynecology at the Cleveland Clinic, said she uses the Mona Lisa Touch, a CO₂ fractionated laser, to treat patients with genitourinary syndrome of menopause (GSM). These patients, Dr. Paraiso said, “complain of vaginal dryness and are unable to have intercourse or experience significant pain during or after intercourse. Some of them also may have irritative voiding, urinary frequency and urgency, or mild stress incontinence.”

Dr. Paraiso’s group has performed some 300 treatments with the laser and “we have fortunately not had patients complaining of persistent vaginal pain or scarring.” About 80%-90% of patients respond, she said, with some 20%-25% seeking retreatment within a year. “I believe for women who have contraindications to hormonal therapy or do not tolerate or cannot afford prolonged hormonal therapy, the CO₂ fractional vaginal laser has been effective.”

Dr. Paraiso is also leading a multisite clinical trial randomizing about 200 patients with GSM to the laser treatment or estrogen-based vaginal creams, and following them for 6 months; thus far, she said, 6 of 89 patients, half in the laser arm, have reported mild to moderate adverse events.

Dr. Paraiso said she does not have a financial relationship with the manufacturer of Mona Lisa Touch, and that the trial was funded by the Foundation for Female Health Awareness, which receives unrestricted research grants from some device makers. “Our institute owns the laser and I have never been paid to train anyone to perform these procedures,” Dr. Paraiso added. “Our onus was to study the laser in order to improve the lives of our patients.”

Other trials comparing vaginal lasers with sham treatment are currently underway or in planning.

The North American Menopause Society struck a cautious note in response to the FDA criticism. In a statement issued August 1, JoAnn Pinkerton, MD, the society’s executive director, said the field needed prospective, randomized, sham-controlled trials of the laser and energy therapies. The therapies “may turn out to be an appropriate choice for many women, particularly for those concerned about breast cancer risk” associated with hormonal treatments. But until more robust data are available, doctors should “discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM.”

Any discussion of vaginal energy-based therapies, should include the disclosure that these have not been approved for the specific indication, Dr. Pinkerton cautioned.

The Food and Drug Administration has issued a stern warning to several manufacturers and a statement of caution to the public concerning “vaginal rejuvenation,” an umbrella term for a host of procedures to alter vaginal tissue for therapeutic or cosmetic purposes.

Lasers and other energy-based devices have been approved to treat abnormal or precancerous cervical or vaginal tissue and general warts, but the FDA has not approved any to treat vaginal atrophy, urinary incontinence, or reduced sexual function.

Device manufacturers claim lasers can address these conditions despite limited scientific evidence for their safety or efficacy. Insurers do not reimburse the procedures, considering them to be cosmetic.

In a July 30 statement, FDA Commissioner Scott Gottlieb, MD, slammed “deceptive” marketing practices on the part of manufacturers.

The FDA has reviewed 12 complaints since December 2015 of adverse effects related to vaginal procedures using the devices. Two were from manufacturers reporting pain and bleeding in patients following treatment, FDA spokeswoman Deborah Kotz said in an interview. “The FDA has also received voluntary MedWatch reports from individual patients who experienced significant pain and discomfort from procedures performed with these devices.”

The agency has targeted seven firms: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and ThermiGen, with letters demanding evidence of FDA approval, clearance, or intent to seek clearance for use of their products on female genitalia. They also asked for evidence backing specific claims.

In a July 26 letter to BTL Industries, for example, the FDA demanded to know why the firm was marketing its Exilis laser device, approved for the treatment of facial wrinkles, as “Ultra Femme 360,” which it called “a whole new approach to women’s intimate health.” The device, according to the manufacturer, “provides the shortest noninvasive radio-frequency treatment available for female intimate parts” and “is proven to increase elastin and collagen in the treatment area.”

The FDA asked Cynosure, the maker of the Mona Lisa Touch, a system marketed as an FDA-approved treatment for vaginal atrophy, for evidence to support its claims that Mona Lisa Touch “is the only technology for vaginal and vulvar health with over 18+ published clinical studies” and is clinically proven to treat “painful symptoms of menopause, including intimacy.” They also asked for information about a modification to the originally approved device that was not brought to the FDA’s attention.

In a letter to Alma Lasers, whose Pixel CO₂ Laser System was approved for use in a broad use of surgical applications including gynecologic surgery, the FDA noted that the device was being marketed as “FEMILIFT,” a laser procedure designed to “improve vaginal irregularities” and to assist “in vaginal mucosa revitalization.” The FDA demanded evidence for those claims.

The manufacturers have 30 days to respond to the FDA, which has not ruled out seeking enforcement action against firms with unsatisfactory responses.

For more than a decade, researchers have shown that healthy vaginal morphology is exceptionally wide ranging, including a recent study in more than 650 women, the largest to date (BJOG. 2018 Jun 25. doi: 10.1111/1471-0528.15387). Nonetheless, interest in elective vaginal procedures has only increased, with an industry report from the International Society of Aesthetic and Plastic Surgery describing a 45% increase in the use of one surgery, vaginal labiaplasty, between 2014 and 2016. Most procedures were performed in Brazil and the United States.

While plastic surgery societies support vaginal rejuvenation procedures, the American College of Obstetricians and Gynecologists has long frowned on them, with its first critique issued in a 2007 committee opinion. “No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures,” the association said last year in its most recent update on the subject.

Gynecologist David M. Jaspan, DO, of the Einstein Healthcare Network in Philadelphia, echoed ACOG’s views and said he welcomed FDA interest in vaginal rejuvenation.

The practice has “never been endorsed by the College or a board. It’s been considered a cosmetic procedure and it’s been under scrutiny for at least a decade,” Dr. Jaspan said. “I have reservations about the clinical outcomes and the training surrounds these procedures and I anxiously await randomized controlled trials to further evaluate them.”

Gynecologists who offer the procedures caution that they may have a role, and that randomized trials are underway to determine which groups of women might be best helped.

Marie Paraiso, MD, professor of obstetrics and gynecology at the Cleveland Clinic, said she uses the Mona Lisa Touch, a CO₂ fractionated laser, to treat patients with genitourinary syndrome of menopause (GSM). These patients, Dr. Paraiso said, “complain of vaginal dryness and are unable to have intercourse or experience significant pain during or after intercourse. Some of them also may have irritative voiding, urinary frequency and urgency, or mild stress incontinence.”

Dr. Paraiso’s group has performed some 300 treatments with the laser and “we have fortunately not had patients complaining of persistent vaginal pain or scarring.” About 80%-90% of patients respond, she said, with some 20%-25% seeking retreatment within a year. “I believe for women who have contraindications to hormonal therapy or do not tolerate or cannot afford prolonged hormonal therapy, the CO₂ fractional vaginal laser has been effective.”

Dr. Paraiso is also leading a multisite clinical trial randomizing about 200 patients with GSM to the laser treatment or estrogen-based vaginal creams, and following them for 6 months; thus far, she said, 6 of 89 patients, half in the laser arm, have reported mild to moderate adverse events.

Dr. Paraiso said she does not have a financial relationship with the manufacturer of Mona Lisa Touch, and that the trial was funded by the Foundation for Female Health Awareness, which receives unrestricted research grants from some device makers. “Our institute owns the laser and I have never been paid to train anyone to perform these procedures,” Dr. Paraiso added. “Our onus was to study the laser in order to improve the lives of our patients.”

Other trials comparing vaginal lasers with sham treatment are currently underway or in planning.

The North American Menopause Society struck a cautious note in response to the FDA criticism. In a statement issued August 1, JoAnn Pinkerton, MD, the society’s executive director, said the field needed prospective, randomized, sham-controlled trials of the laser and energy therapies. The therapies “may turn out to be an appropriate choice for many women, particularly for those concerned about breast cancer risk” associated with hormonal treatments. But until more robust data are available, doctors should “discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM.”

Any discussion of vaginal energy-based therapies, should include the disclosure that these have not been approved for the specific indication, Dr. Pinkerton cautioned.

The Food and Drug Administration has issued a stern warning to several manufacturers and a statement of caution to the public concerning “vaginal rejuvenation,” an umbrella term for a host of procedures to alter vaginal tissue for therapeutic or cosmetic purposes.

Lasers and other energy-based devices have been approved to treat abnormal or precancerous cervical or vaginal tissue and general warts, but the FDA has not approved any to treat vaginal atrophy, urinary incontinence, or reduced sexual function.

Device manufacturers claim lasers can address these conditions despite limited scientific evidence for their safety or efficacy. Insurers do not reimburse the procedures, considering them to be cosmetic.

In a July 30 statement, FDA Commissioner Scott Gottlieb, MD, slammed “deceptive” marketing practices on the part of manufacturers.

The FDA has reviewed 12 complaints since December 2015 of adverse effects related to vaginal procedures using the devices. Two were from manufacturers reporting pain and bleeding in patients following treatment, FDA spokeswoman Deborah Kotz said in an interview. “The FDA has also received voluntary MedWatch reports from individual patients who experienced significant pain and discomfort from procedures performed with these devices.”

The agency has targeted seven firms: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and ThermiGen, with letters demanding evidence of FDA approval, clearance, or intent to seek clearance for use of their products on female genitalia. They also asked for evidence backing specific claims.

In a July 26 letter to BTL Industries, for example, the FDA demanded to know why the firm was marketing its Exilis laser device, approved for the treatment of facial wrinkles, as “Ultra Femme 360,” which it called “a whole new approach to women’s intimate health.” The device, according to the manufacturer, “provides the shortest noninvasive radio-frequency treatment available for female intimate parts” and “is proven to increase elastin and collagen in the treatment area.”

The FDA asked Cynosure, the maker of the Mona Lisa Touch, a system marketed as an FDA-approved treatment for vaginal atrophy, for evidence to support its claims that Mona Lisa Touch “is the only technology for vaginal and vulvar health with over 18+ published clinical studies” and is clinically proven to treat “painful symptoms of menopause, including intimacy.” They also asked for information about a modification to the originally approved device that was not brought to the FDA’s attention.

In a letter to Alma Lasers, whose Pixel CO₂ Laser System was approved for use in a broad use of surgical applications including gynecologic surgery, the FDA noted that the device was being marketed as “FEMILIFT,” a laser procedure designed to “improve vaginal irregularities” and to assist “in vaginal mucosa revitalization.” The FDA demanded evidence for those claims.

The manufacturers have 30 days to respond to the FDA, which has not ruled out seeking enforcement action against firms with unsatisfactory responses.

For more than a decade, researchers have shown that healthy vaginal morphology is exceptionally wide ranging, including a recent study in more than 650 women, the largest to date (BJOG. 2018 Jun 25. doi: 10.1111/1471-0528.15387). Nonetheless, interest in elective vaginal procedures has only increased, with an industry report from the International Society of Aesthetic and Plastic Surgery describing a 45% increase in the use of one surgery, vaginal labiaplasty, between 2014 and 2016. Most procedures were performed in Brazil and the United States.

While plastic surgery societies support vaginal rejuvenation procedures, the American College of Obstetricians and Gynecologists has long frowned on them, with its first critique issued in a 2007 committee opinion. “No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures,” the association said last year in its most recent update on the subject.

Gynecologist David M. Jaspan, DO, of the Einstein Healthcare Network in Philadelphia, echoed ACOG’s views and said he welcomed FDA interest in vaginal rejuvenation.

The practice has “never been endorsed by the College or a board. It’s been considered a cosmetic procedure and it’s been under scrutiny for at least a decade,” Dr. Jaspan said. “I have reservations about the clinical outcomes and the training surrounds these procedures and I anxiously await randomized controlled trials to further evaluate them.”

Gynecologists who offer the procedures caution that they may have a role, and that randomized trials are underway to determine which groups of women might be best helped.

Marie Paraiso, MD, professor of obstetrics and gynecology at the Cleveland Clinic, said she uses the Mona Lisa Touch, a CO₂ fractionated laser, to treat patients with genitourinary syndrome of menopause (GSM). These patients, Dr. Paraiso said, “complain of vaginal dryness and are unable to have intercourse or experience significant pain during or after intercourse. Some of them also may have irritative voiding, urinary frequency and urgency, or mild stress incontinence.”

Dr. Paraiso’s group has performed some 300 treatments with the laser and “we have fortunately not had patients complaining of persistent vaginal pain or scarring.” About 80%-90% of patients respond, she said, with some 20%-25% seeking retreatment within a year. “I believe for women who have contraindications to hormonal therapy or do not tolerate or cannot afford prolonged hormonal therapy, the CO₂ fractional vaginal laser has been effective.”

Dr. Paraiso is also leading a multisite clinical trial randomizing about 200 patients with GSM to the laser treatment or estrogen-based vaginal creams, and following them for 6 months; thus far, she said, 6 of 89 patients, half in the laser arm, have reported mild to moderate adverse events.

Dr. Paraiso said she does not have a financial relationship with the manufacturer of Mona Lisa Touch, and that the trial was funded by the Foundation for Female Health Awareness, which receives unrestricted research grants from some device makers. “Our institute owns the laser and I have never been paid to train anyone to perform these procedures,” Dr. Paraiso added. “Our onus was to study the laser in order to improve the lives of our patients.”

Other trials comparing vaginal lasers with sham treatment are currently underway or in planning.

The North American Menopause Society struck a cautious note in response to the FDA criticism. In a statement issued August 1, JoAnn Pinkerton, MD, the society’s executive director, said the field needed prospective, randomized, sham-controlled trials of the laser and energy therapies. The therapies “may turn out to be an appropriate choice for many women, particularly for those concerned about breast cancer risk” associated with hormonal treatments. But until more robust data are available, doctors should “discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM.”

Any discussion of vaginal energy-based therapies, should include the disclosure that these have not been approved for the specific indication, Dr. Pinkerton cautioned.

Leading medical societies are calling on the Trump administration to withdraw its proposed changes to the federal Title X family planning program, calling the modifications a threat to essential health care for women.

In late May, the Department of Health & Human Services proposed broad changes to Title X, including no longer allowing staff at Title X clinics to counsel, refer, or provide information to women about abortions and mandating that Title X clinics that offer abortions maintain a separate facility for abortion services. The proposed changes aim to “refocus” the Title X program and ensure that all Title X services align with its family planning mission, according to the proposed rule published June 1.

In a July 31 letter to HHS, the American Medical Association requested that HHS withdraw the proposal, citing concerns from the medical community.

“We are very concerned that the proposed changes, if implemented, would undermine patients’ access to high-quality medical care and information, dangerously interfere with the patient-physician relationship and conflict with physicians’ ethical obligations, exclude qualified providers, and jeopardize public health,” James L. Madara, MD, chief executive officer and vice president of the AMA, wrote in a letter. “We urge HHS to withdraw this [proposal].”

The American College of Obstetricians and Gynecologists, the American College of Physicians, the American Academy of Pediatrics, the American Psychiatric Association, and 13 other health care associations also have called on the HHS to rescind its proposed rule. According to a statement from these associations, the proposal endangers women’s lives by restricting access to medically accurate information and preventive health care.

Title X is a long-standing federal program that provides funding for women’s health care and comprehensive family planning services, primarily to low-income and uninsured patients. Federal law prohibits the use of Title X funds to pay for abortions.

Under the proposed regulations, the Trump administration would define “family planning” as the voluntary process of identifying goals and developing a plan for the number and spacing of children and the means by which those goals may be achieved. This includes planning methods and services “to limit or enhance the likelihood of conception, including contraceptive methods and natural family planning or other fertility awareness-based methods,” according to the proposal. HHS specifies that family planning does not include postconception care, obstetric or prenatal care, or abortion as a method of family planning. HHS has proposed that, if a woman comes to a Title X–funded clinic and is pregnant, she be referred externally for pregnancy services. However, the proposed rule would no longer allow Title X programs to provide abortion counseling and/or referral.

According to HHS, requiring separate facilities for abortion-related care would ensure that Title X funds are used for the purposes expressly mandated by Congress – to offer family planning methods and services – and that any infrastructure built with Title X funds would not be used for impermissible purposes.

More than 100,000 comments have been submitted on the proposed rule since June. Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support for the proposed rule.

“The American people have repeatedly expressed their predominant policy preferences by supporting Congressional enactments designed to distinguish and separate abortion from family planning,” SBA List President Marjorie Dannenfelser wrote in a comment. “Abortion is not health care, nor is abortion family planning. The Clinton administration and subsequent presidential administrations have erroneously allowed the blatant distribution of Title X funding to abortion centers and abortion-referral facilities for years and in direct violation of the original purpose of Title X funding.”

A group of 14 state governors, meanwhile, has threatened legal action if the Trump administration moves forward with finalizing its rule. In a May 31 letter, the 14 Democratic governors urged HHS to halt its changes to the Title X program and said they would explore all options, including legal avenues, to protect patients’ access to care. More recently, Democratic governors in Washington, Oregon, Hawaii, and New York have said they will refuse all Title X funding if the Trump administration does not rescind its proposed changes to the program.

“This is not an issue about life or choices. This is an issue about the rights of millions of individuals who deserve the best health care available,” Hawaii governor David Ige said in a July 30 statement. “Hawaii will not accept federal funds for these programs if the proposed rules are implemented.”

Public comment on the proposed rule closed on July 31.

Leading medical societies are calling on the Trump administration to withdraw its proposed changes to the federal Title X family planning program, calling the modifications a threat to essential health care for women.

In late May, the Department of Health & Human Services proposed broad changes to Title X, including no longer allowing staff at Title X clinics to counsel, refer, or provide information to women about abortions and mandating that Title X clinics that offer abortions maintain a separate facility for abortion services. The proposed changes aim to “refocus” the Title X program and ensure that all Title X services align with its family planning mission, according to the proposed rule published June 1.

In a July 31 letter to HHS, the American Medical Association requested that HHS withdraw the proposal, citing concerns from the medical community.

“We are very concerned that the proposed changes, if implemented, would undermine patients’ access to high-quality medical care and information, dangerously interfere with the patient-physician relationship and conflict with physicians’ ethical obligations, exclude qualified providers, and jeopardize public health,” James L. Madara, MD, chief executive officer and vice president of the AMA, wrote in a letter. “We urge HHS to withdraw this [proposal].”

The American College of Obstetricians and Gynecologists, the American College of Physicians, the American Academy of Pediatrics, the American Psychiatric Association, and 13 other health care associations also have called on the HHS to rescind its proposed rule. According to a statement from these associations, the proposal endangers women’s lives by restricting access to medically accurate information and preventive health care.

Title X is a long-standing federal program that provides funding for women’s health care and comprehensive family planning services, primarily to low-income and uninsured patients. Federal law prohibits the use of Title X funds to pay for abortions.

Under the proposed regulations, the Trump administration would define “family planning” as the voluntary process of identifying goals and developing a plan for the number and spacing of children and the means by which those goals may be achieved. This includes planning methods and services “to limit or enhance the likelihood of conception, including contraceptive methods and natural family planning or other fertility awareness-based methods,” according to the proposal. HHS specifies that family planning does not include postconception care, obstetric or prenatal care, or abortion as a method of family planning. HHS has proposed that, if a woman comes to a Title X–funded clinic and is pregnant, she be referred externally for pregnancy services. However, the proposed rule would no longer allow Title X programs to provide abortion counseling and/or referral.

According to HHS, requiring separate facilities for abortion-related care would ensure that Title X funds are used for the purposes expressly mandated by Congress – to offer family planning methods and services – and that any infrastructure built with Title X funds would not be used for impermissible purposes.

More than 100,000 comments have been submitted on the proposed rule since June. Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support for the proposed rule.

“The American people have repeatedly expressed their predominant policy preferences by supporting Congressional enactments designed to distinguish and separate abortion from family planning,” SBA List President Marjorie Dannenfelser wrote in a comment. “Abortion is not health care, nor is abortion family planning. The Clinton administration and subsequent presidential administrations have erroneously allowed the blatant distribution of Title X funding to abortion centers and abortion-referral facilities for years and in direct violation of the original purpose of Title X funding.”

A group of 14 state governors, meanwhile, has threatened legal action if the Trump administration moves forward with finalizing its rule. In a May 31 letter, the 14 Democratic governors urged HHS to halt its changes to the Title X program and said they would explore all options, including legal avenues, to protect patients’ access to care. More recently, Democratic governors in Washington, Oregon, Hawaii, and New York have said they will refuse all Title X funding if the Trump administration does not rescind its proposed changes to the program.

“This is not an issue about life or choices. This is an issue about the rights of millions of individuals who deserve the best health care available,” Hawaii governor David Ige said in a July 30 statement. “Hawaii will not accept federal funds for these programs if the proposed rules are implemented.”

Public comment on the proposed rule closed on July 31.

Leading medical societies are calling on the Trump administration to withdraw its proposed changes to the federal Title X family planning program, calling the modifications a threat to essential health care for women.

In late May, the Department of Health & Human Services proposed broad changes to Title X, including no longer allowing staff at Title X clinics to counsel, refer, or provide information to women about abortions and mandating that Title X clinics that offer abortions maintain a separate facility for abortion services. The proposed changes aim to “refocus” the Title X program and ensure that all Title X services align with its family planning mission, according to the proposed rule published June 1.

In a July 31 letter to HHS, the American Medical Association requested that HHS withdraw the proposal, citing concerns from the medical community.

“We are very concerned that the proposed changes, if implemented, would undermine patients’ access to high-quality medical care and information, dangerously interfere with the patient-physician relationship and conflict with physicians’ ethical obligations, exclude qualified providers, and jeopardize public health,” James L. Madara, MD, chief executive officer and vice president of the AMA, wrote in a letter. “We urge HHS to withdraw this [proposal].”

The American College of Obstetricians and Gynecologists, the American College of Physicians, the American Academy of Pediatrics, the American Psychiatric Association, and 13 other health care associations also have called on the HHS to rescind its proposed rule. According to a statement from these associations, the proposal endangers women’s lives by restricting access to medically accurate information and preventive health care.

Title X is a long-standing federal program that provides funding for women’s health care and comprehensive family planning services, primarily to low-income and uninsured patients. Federal law prohibits the use of Title X funds to pay for abortions.

Under the proposed regulations, the Trump administration would define “family planning” as the voluntary process of identifying goals and developing a plan for the number and spacing of children and the means by which those goals may be achieved. This includes planning methods and services “to limit or enhance the likelihood of conception, including contraceptive methods and natural family planning or other fertility awareness-based methods,” according to the proposal. HHS specifies that family planning does not include postconception care, obstetric or prenatal care, or abortion as a method of family planning. HHS has proposed that, if a woman comes to a Title X–funded clinic and is pregnant, she be referred externally for pregnancy services. However, the proposed rule would no longer allow Title X programs to provide abortion counseling and/or referral.

According to HHS, requiring separate facilities for abortion-related care would ensure that Title X funds are used for the purposes expressly mandated by Congress – to offer family planning methods and services – and that any infrastructure built with Title X funds would not be used for impermissible purposes.

More than 100,000 comments have been submitted on the proposed rule since June. Antiabortion organizations, such as the Susan B. Anthony List, have expressed strong support for the proposed rule.

“The American people have repeatedly expressed their predominant policy preferences by supporting Congressional enactments designed to distinguish and separate abortion from family planning,” SBA List President Marjorie Dannenfelser wrote in a comment. “Abortion is not health care, nor is abortion family planning. The Clinton administration and subsequent presidential administrations have erroneously allowed the blatant distribution of Title X funding to abortion centers and abortion-referral facilities for years and in direct violation of the original purpose of Title X funding.”

A group of 14 state governors, meanwhile, has threatened legal action if the Trump administration moves forward with finalizing its rule. In a May 31 letter, the 14 Democratic governors urged HHS to halt its changes to the Title X program and said they would explore all options, including legal avenues, to protect patients’ access to care. More recently, Democratic governors in Washington, Oregon, Hawaii, and New York have said they will refuse all Title X funding if the Trump administration does not rescind its proposed changes to the program.

“This is not an issue about life or choices. This is an issue about the rights of millions of individuals who deserve the best health care available,” Hawaii governor David Ige said in a July 30 statement. “Hawaii will not accept federal funds for these programs if the proposed rules are implemented.”

Public comment on the proposed rule closed on July 31.

Each time this 32-year-old woman has a baby—she’s had four to date—she notices that sections of her face darken. Early on, she observed a pattern in which the coming of winter coincided with a lightening of these affected areas—but now the effect lasts year-round, with progressive darkening. She has not tried any products (OTC or prescription) for this problem.

Growing up in the South, the patient and her family spent most summers boating, swimming, and fishing. Her use of sunscreen was sporadic, but she would tan easily regardless.

Her health is good, aside from a 15-year history of smoking.

EXAMINATION
There is excessive hyperpigmentation (brown) on the patient’s face. It follows a mask-like pattern, including her maxilla and the periphery of her face.

Elsewhere, there is abundant evidence of excessive sun exposure, with focal hyperpigmentation and telangiectasias on her arms. She has type IV skin, consistent with her Native American ancestry.

What is the diagnosis?

DISCUSSION
Melasma, also known as chloasma and dubbed the “mask of pregnancy,” is an extremely common problem that results from a combination of naturally dark skin, lots of sun exposure, and increased levels of estrogenic hormones. The latter can result from pregnancy or from oral contraceptive or estrogen replacement therapy use. Another precipitating factor is thyroid disease, certain types of which lead to an increase in melanocytic stimulating hormone.

Melasma, as one might expect, is seen almost exclusively in women, though a rare male is affected. It is especially common among Latina, Native American, and African-American women, whose melanocytes are especially able to produce pigment.

There are several treatments for melasma, none of them perfect, including tretinoin, azelaic acid, chemical peels, dermabrasion, and lasers. The most common treatment is hydroquinone cream, available in the US in both OTC (2%) and prescription (4%) strengths. However, hydroquinone is available OTC in stronger formulations (15% to 20%) in many Central and South American countries; unfortunately, many women who obtain and use these products experience exogenous ochronosis—a worsening or even precipitation of melasma, resulting from excessive production of tyrosinase.

Any treatment must be used in conjunction with rigorous sunscreen application. A full-spectrum product, with titanium dioxide and zinc oxide as the only active ingredients, must be used, because chemical-laden sunscreens don’t do as good a job covering UVA, UVB, and visible light. Convincing women who are unaccustomed to needing sunscreen to use it religiously is part of what makes treating melasma difficult.

The differential for melasma includes postinflammatory hyperpigmentation (eg, following an episode of contact dermatitis) and simple solar lentigines.

This patient was treated with hydroquinone 4% cream bid, plus sunscreen. She was also given information about other treatment options, such as laser and dermabrasion.

TAKE-HOME LEARNING POINTS

• Melasma, also known at chloasma, is quite common, especially among women with darker skin who live in sunny parts of the world.
• It results from a combination of dark skin, an increased level of estrogenic hormones (eg, with pregnancy, birth control pills, or estrogen replacement therapy), and excessive exposure to UV light.
• While hydroquinone cream can be an effective treatment, the maximum strength should be 4%; overuse of stronger concentrations (available in other countries, such as Mexico), can actually cause melasma to worsen.

Each time this 32-year-old woman has a baby—she’s had four to date—she notices that sections of her face darken. Early on, she observed a pattern in which the coming of winter coincided with a lightening of these affected areas—but now the effect lasts year-round, with progressive darkening. She has not tried any products (OTC or prescription) for this problem.

Growing up in the South, the patient and her family spent most summers boating, swimming, and fishing. Her use of sunscreen was sporadic, but she would tan easily regardless.

Her health is good, aside from a 15-year history of smoking.

EXAMINATION
There is excessive hyperpigmentation (brown) on the patient’s face. It follows a mask-like pattern, including her maxilla and the periphery of her face.

Elsewhere, there is abundant evidence of excessive sun exposure, with focal hyperpigmentation and telangiectasias on her arms. She has type IV skin, consistent with her Native American ancestry.

What is the diagnosis?

DISCUSSION
Melasma, also known as chloasma and dubbed the “mask of pregnancy,” is an extremely common problem that results from a combination of naturally dark skin, lots of sun exposure, and increased levels of estrogenic hormones. The latter can result from pregnancy or from oral contraceptive or estrogen replacement therapy use. Another precipitating factor is thyroid disease, certain types of which lead to an increase in melanocytic stimulating hormone.

Melasma, as one might expect, is seen almost exclusively in women, though a rare male is affected. It is especially common among Latina, Native American, and African-American women, whose melanocytes are especially able to produce pigment.

There are several treatments for melasma, none of them perfect, including tretinoin, azelaic acid, chemical peels, dermabrasion, and lasers. The most common treatment is hydroquinone cream, available in the US in both OTC (2%) and prescription (4%) strengths. However, hydroquinone is available OTC in stronger formulations (15% to 20%) in many Central and South American countries; unfortunately, many women who obtain and use these products experience exogenous ochronosis—a worsening or even precipitation of melasma, resulting from excessive production of tyrosinase.

Any treatment must be used in conjunction with rigorous sunscreen application. A full-spectrum product, with titanium dioxide and zinc oxide as the only active ingredients, must be used, because chemical-laden sunscreens don’t do as good a job covering UVA, UVB, and visible light. Convincing women who are unaccustomed to needing sunscreen to use it religiously is part of what makes treating melasma difficult.

The differential for melasma includes postinflammatory hyperpigmentation (eg, following an episode of contact dermatitis) and simple solar lentigines.

This patient was treated with hydroquinone 4% cream bid, plus sunscreen. She was also given information about other treatment options, such as laser and dermabrasion.

TAKE-HOME LEARNING POINTS

• Melasma, also known at chloasma, is quite common, especially among women with darker skin who live in sunny parts of the world.
• It results from a combination of dark skin, an increased level of estrogenic hormones (eg, with pregnancy, birth control pills, or estrogen replacement therapy), and excessive exposure to UV light.
• While hydroquinone cream can be an effective treatment, the maximum strength should be 4%; overuse of stronger concentrations (available in other countries, such as Mexico), can actually cause melasma to worsen.

Each time this 32-year-old woman has a baby—she’s had four to date—she notices that sections of her face darken. Early on, she observed a pattern in which the coming of winter coincided with a lightening of these affected areas—but now the effect lasts year-round, with progressive darkening. She has not tried any products (OTC or prescription) for this problem.

Growing up in the South, the patient and her family spent most summers boating, swimming, and fishing. Her use of sunscreen was sporadic, but she would tan easily regardless.

Her health is good, aside from a 15-year history of smoking.

EXAMINATION
There is excessive hyperpigmentation (brown) on the patient’s face. It follows a mask-like pattern, including her maxilla and the periphery of her face.

Elsewhere, there is abundant evidence of excessive sun exposure, with focal hyperpigmentation and telangiectasias on her arms. She has type IV skin, consistent with her Native American ancestry.

What is the diagnosis?

DISCUSSION
Melasma, also known as chloasma and dubbed the “mask of pregnancy,” is an extremely common problem that results from a combination of naturally dark skin, lots of sun exposure, and increased levels of estrogenic hormones. The latter can result from pregnancy or from oral contraceptive or estrogen replacement therapy use. Another precipitating factor is thyroid disease, certain types of which lead to an increase in melanocytic stimulating hormone.

Melasma, as one might expect, is seen almost exclusively in women, though a rare male is affected. It is especially common among Latina, Native American, and African-American women, whose melanocytes are especially able to produce pigment.

There are several treatments for melasma, none of them perfect, including tretinoin, azelaic acid, chemical peels, dermabrasion, and lasers. The most common treatment is hydroquinone cream, available in the US in both OTC (2%) and prescription (4%) strengths. However, hydroquinone is available OTC in stronger formulations (15% to 20%) in many Central and South American countries; unfortunately, many women who obtain and use these products experience exogenous ochronosis—a worsening or even precipitation of melasma, resulting from excessive production of tyrosinase.

Any treatment must be used in conjunction with rigorous sunscreen application. A full-spectrum product, with titanium dioxide and zinc oxide as the only active ingredients, must be used, because chemical-laden sunscreens don’t do as good a job covering UVA, UVB, and visible light. Convincing women who are unaccustomed to needing sunscreen to use it religiously is part of what makes treating melasma difficult.

The differential for melasma includes postinflammatory hyperpigmentation (eg, following an episode of contact dermatitis) and simple solar lentigines.

This patient was treated with hydroquinone 4% cream bid, plus sunscreen. She was also given information about other treatment options, such as laser and dermabrasion.

TAKE-HOME LEARNING POINTS

• Melasma, also known at chloasma, is quite common, especially among women with darker skin who live in sunny parts of the world.
• It results from a combination of dark skin, an increased level of estrogenic hormones (eg, with pregnancy, birth control pills, or estrogen replacement therapy), and excessive exposure to UV light.
• While hydroquinone cream can be an effective treatment, the maximum strength should be 4%; overuse of stronger concentrations (available in other countries, such as Mexico), can actually cause melasma to worsen.