Contraception

The first vaginal ring contraceptive that can be used for 1 year has been approved by the Food and Drug Administration.

The FDA granted approval of Annovera (segesterone acetate and ethinyl estradiol vaginal system), a reusable donut-shaped ring, to the Population Council. The nonbiodegradable, flexible vaginal system is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a menstrual period. This schedule is repeated every 4 weeks for 13 28-day menstrual cycles.

The contraceptive ring is washed and stored in a compact case for the 7 days when it is not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).

“Today’s approval builds on available birth control options,” said Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

The efficacy and safety of Annovera were studied in three, open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about 2%-4% of women may get pregnant during the first year they use Annovera.

Annovera carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Women over age 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

Annovera is contraindicated for women with a high risk of arterial or venous thrombotic diseases; a history of breast cancer or another estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of Annovera; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, according to an FDA press release.

The most common side effects of Annovera are similar to those of other combined hormonal contraceptive products and include headache, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism and the effects of CYP3A-modulating drugs and tampon use on the pharmacokinetics of Annovera.

[email protected]

The first vaginal ring contraceptive that can be used for 1 year has been approved by the Food and Drug Administration.

The FDA granted approval of Annovera (segesterone acetate and ethinyl estradiol vaginal system), a reusable donut-shaped ring, to the Population Council. The nonbiodegradable, flexible vaginal system is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a menstrual period. This schedule is repeated every 4 weeks for 13 28-day menstrual cycles.

The contraceptive ring is washed and stored in a compact case for the 7 days when it is not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).

“Today’s approval builds on available birth control options,” said Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

The efficacy and safety of Annovera were studied in three, open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about 2%-4% of women may get pregnant during the first year they use Annovera.

Annovera carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Women over age 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

Annovera is contraindicated for women with a high risk of arterial or venous thrombotic diseases; a history of breast cancer or another estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of Annovera; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, according to an FDA press release.

The most common side effects of Annovera are similar to those of other combined hormonal contraceptive products and include headache, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism and the effects of CYP3A-modulating drugs and tampon use on the pharmacokinetics of Annovera.

[email protected]

The first vaginal ring contraceptive that can be used for 1 year has been approved by the Food and Drug Administration.

The FDA granted approval of Annovera (segesterone acetate and ethinyl estradiol vaginal system), a reusable donut-shaped ring, to the Population Council. The nonbiodegradable, flexible vaginal system is placed in the vagina for 3 weeks followed by 1 week out of the vagina, at which time women may experience a menstrual period. This schedule is repeated every 4 weeks for 13 28-day menstrual cycles.

The contraceptive ring is washed and stored in a compact case for the 7 days when it is not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30° C (86° F).

“Today’s approval builds on available birth control options,” said Victor Crentsil, MD, acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

The efficacy and safety of Annovera were studied in three, open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about 2%-4% of women may get pregnant during the first year they use Annovera.

Annovera carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Women over age 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

Annovera is contraindicated for women with a high risk of arterial or venous thrombotic diseases; a history of breast cancer or another estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of Annovera; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, according to an FDA press release.

The most common side effects of Annovera are similar to those of other combined hormonal contraceptive products and include headache, nausea and vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea, and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism and the effects of CYP3A-modulating drugs and tampon use on the pharmacokinetics of Annovera.

[email protected]

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 use of hormonal contraception in women with headaches, especially migraine headaches, is an important topic. Approximately 43% of women in the United States report migraines.¹ Roughly the same percentage of reproductive-aged women use hormonal contraception.² Data suggest that all migraineurs have some increased risk of stroke. Therefore, can women with migraine headaches use combination hormonal contraception? And can women with severe headaches that are nonmigrainous use combination hormonal contraception? Let’s examine available data to help us answer these questions.

Risk factors for stroke

Migraine without aura is the most common subset, but migraine with aura is more problematic relative to the increased incidence of stroke.¹

A migraine aura is visual 90% of the time.¹ Symptoms can include flickering lights, spots, zigzag lines, a sense of pins and needles, or dysphasic speech. Aura precedes the headache and usually resolves within 1 hour after the aura begins.

In addition to migraine headaches, risk factors for stroke include increasing age, hypertension, the use of combination oral contraceptives (COCs), the contraceptive patch and ring, and smoking.¹

Data indicate that the risk for ischemic stroke is increased in women with migraines even without the presence of other risk factors. In a meta-analysis of 14 observational studies, the risk of ischemic stroke among all migraineurs was about 2-fold (relative risk [RR], 2.2; 95% confidence interval [CI], 1.9–2.5) compared with the risk of ischemic stroke in women of the same age group who did not have migraine headaches. When there is migraine without aura, it was slightly less than 2-fold (RR, 1.8; 95% CI, 1.1–3.2). The risk of ischemic stroke among migraineurs with aura is increased more than 2 times compared with women without migraine (RR, 2.27; 95% CI, 1.61–3.19).³ However, the absolute risk of ischemic stroke among reproductive-aged women is 11 per 100,000 women years.⁴

Two observational studies show how additional risk factors increase that risk (TABLE).^5,6 There are similar trends in terms of overall risk of stroke among women with all types of migraine. However, when you add smoking as an additional risk factor for women with migraine headaches, there is a substantial increase in the risk of stroke. When a woman who has migraines uses COCs, there is increased risk varying from 2-fold to almost 4-fold. When you combine migraine, smoking, and COCs, a very, very large risk factor (odds ratio [OR], 34.4; 95% CI, 3.27–3.61) was reported by Chang and colleagues.⁶

Although these risks are impressive, it is important to keep in mind that even with a 10-fold increase, we are only talking about 1 case per 1,000 migraineurs.⁴ Unfortunately, stroke often leads to major disability and even death, such that any reduction in risk is still important.

Preventing estrogen withdrawal or menstrual migraines

How should we treat a woman who uses hormonal contraception and reports estrogen withdrawal or menstrual migraines? Based on clinical evidence, there are 2 ways to reduce her symptoms:

• COCs. Reduce the hormone-free interval by having her take COCs for 3 to 4 days instead of 7 days, or eliminate the hormone-free interval altogether by continuous use of COCs, usually 3 months at a time.⁷
• NSAIDs. For those who do not want to alter how they take their hormonal product, use nonsteroidal anti-inflammatory drugs (NSAIDs) starting 7 days before the onset of menses and continuing for 13 days. In a clinical trial by Sances and colleagues, this plan reduced the frequency, duration, and severity of menstrual migraines.⁸

Probably altering how she takes the COC would make the most sense for most individuals instead of taking NSAIDs for 75% of each month.

Recommendations from the US MEC

The US Medical Eligibility Criteria (US MEC) from the Centers for Disease Control and Prevention (CDC) offers recommendations for contraceptive use⁹:

• For nonmigrainous headache, the CDC suggests that the benefits of using COCs outweigh the risks unless the headaches persist after 3 months of COC use.

• For migraine without aura, the benefits outweigh the risks in starting women who are younger than age 35 years on oral contraceptives. However, the risks of COCs outweigh the benefits in women who are age 35 years and older who develop migraine headache while on COCs, or who have risk factors for stroke.

• For migraine with aura, COCs are contraindicated.
• Progestin-only contraceptives. The CDC considers that the benefits of COC use outweigh any theoretical risk of stroke, even in women with risk factors or in women who have migraine with aura. Progestin-only contraceptives do not alter one’s risk of stroke, unlike contraceptives that contain estrogen.

My bottom line

Can women with migraine headaches begin the use of combination hormonal methods? Yes, if there is no aura in their migraines and they are not older than age 35.

Can women with severe headaches that are nonmigrainous use combination hormonal methods? Possibly, but you should discontinue COCs if headache severity persists or worsens, using a 3-month time period for evaluation.

How do you manage women with migraines during the hormone-free interval? Consider the continuous method or shorten the hormone-free interval.

Recommendations for complicated patients. Consulting the CDC’s US MEC database⁷ can provide assistance in your care of more complicated patients requesting contraception. I also recommend the book, “Contraception for the Medically Challenging Patient,” edited by Rebecca Allen and Carrie Cwiak.¹⁰ It links nicely with the CDC guidelines and presents more detail on each subject.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The use of hormonal contraception in women with headaches, especially migraine headaches, is an important topic. Approximately 43% of women in the United States report migraines.¹ Roughly the same percentage of reproductive-aged women use hormonal contraception.² Data suggest that all migraineurs have some increased risk of stroke. Therefore, can women with migraine headaches use combination hormonal contraception? And can women with severe headaches that are nonmigrainous use combination hormonal contraception? Let’s examine available data to help us answer these questions.

Risk factors for stroke

Migraine without aura is the most common subset, but migraine with aura is more problematic relative to the increased incidence of stroke.¹

A migraine aura is visual 90% of the time.¹ Symptoms can include flickering lights, spots, zigzag lines, a sense of pins and needles, or dysphasic speech. Aura precedes the headache and usually resolves within 1 hour after the aura begins.

In addition to migraine headaches, risk factors for stroke include increasing age, hypertension, the use of combination oral contraceptives (COCs), the contraceptive patch and ring, and smoking.¹

Data indicate that the risk for ischemic stroke is increased in women with migraines even without the presence of other risk factors. In a meta-analysis of 14 observational studies, the risk of ischemic stroke among all migraineurs was about 2-fold (relative risk [RR], 2.2; 95% confidence interval [CI], 1.9–2.5) compared with the risk of ischemic stroke in women of the same age group who did not have migraine headaches. When there is migraine without aura, it was slightly less than 2-fold (RR, 1.8; 95% CI, 1.1–3.2). The risk of ischemic stroke among migraineurs with aura is increased more than 2 times compared with women without migraine (RR, 2.27; 95% CI, 1.61–3.19).³ However, the absolute risk of ischemic stroke among reproductive-aged women is 11 per 100,000 women years.⁴

Two observational studies show how additional risk factors increase that risk (TABLE).^5,6 There are similar trends in terms of overall risk of stroke among women with all types of migraine. However, when you add smoking as an additional risk factor for women with migraine headaches, there is a substantial increase in the risk of stroke. When a woman who has migraines uses COCs, there is increased risk varying from 2-fold to almost 4-fold. When you combine migraine, smoking, and COCs, a very, very large risk factor (odds ratio [OR], 34.4; 95% CI, 3.27–3.61) was reported by Chang and colleagues.⁶

Although these risks are impressive, it is important to keep in mind that even with a 10-fold increase, we are only talking about 1 case per 1,000 migraineurs.⁴ Unfortunately, stroke often leads to major disability and even death, such that any reduction in risk is still important.

Preventing estrogen withdrawal or menstrual migraines

How should we treat a woman who uses hormonal contraception and reports estrogen withdrawal or menstrual migraines? Based on clinical evidence, there are 2 ways to reduce her symptoms:

• COCs. Reduce the hormone-free interval by having her take COCs for 3 to 4 days instead of 7 days, or eliminate the hormone-free interval altogether by continuous use of COCs, usually 3 months at a time.⁷
• NSAIDs. For those who do not want to alter how they take their hormonal product, use nonsteroidal anti-inflammatory drugs (NSAIDs) starting 7 days before the onset of menses and continuing for 13 days. In a clinical trial by Sances and colleagues, this plan reduced the frequency, duration, and severity of menstrual migraines.⁸

Probably altering how she takes the COC would make the most sense for most individuals instead of taking NSAIDs for 75% of each month.

Recommendations from the US MEC

The US Medical Eligibility Criteria (US MEC) from the Centers for Disease Control and Prevention (CDC) offers recommendations for contraceptive use⁹:

• For nonmigrainous headache, the CDC suggests that the benefits of using COCs outweigh the risks unless the headaches persist after 3 months of COC use.

• For migraine without aura, the benefits outweigh the risks in starting women who are younger than age 35 years on oral contraceptives. However, the risks of COCs outweigh the benefits in women who are age 35 years and older who develop migraine headache while on COCs, or who have risk factors for stroke.

• For migraine with aura, COCs are contraindicated.
• Progestin-only contraceptives. The CDC considers that the benefits of COC use outweigh any theoretical risk of stroke, even in women with risk factors or in women who have migraine with aura. Progestin-only contraceptives do not alter one’s risk of stroke, unlike contraceptives that contain estrogen.

My bottom line

Can women with migraine headaches begin the use of combination hormonal methods? Yes, if there is no aura in their migraines and they are not older than age 35.

Can women with severe headaches that are nonmigrainous use combination hormonal methods? Possibly, but you should discontinue COCs if headache severity persists or worsens, using a 3-month time period for evaluation.

How do you manage women with migraines during the hormone-free interval? Consider the continuous method or shorten the hormone-free interval.

Recommendations for complicated patients. Consulting the CDC’s US MEC database⁷ can provide assistance in your care of more complicated patients requesting contraception. I also recommend the book, “Contraception for the Medically Challenging Patient,” edited by Rebecca Allen and Carrie Cwiak.¹⁰ It links nicely with the CDC guidelines and presents more detail on each subject.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The use of hormonal contraception in women with headaches, especially migraine headaches, is an important topic. Approximately 43% of women in the United States report migraines.¹ Roughly the same percentage of reproductive-aged women use hormonal contraception.² Data suggest that all migraineurs have some increased risk of stroke. Therefore, can women with migraine headaches use combination hormonal contraception? And can women with severe headaches that are nonmigrainous use combination hormonal contraception? Let’s examine available data to help us answer these questions.

Risk factors for stroke

Migraine without aura is the most common subset, but migraine with aura is more problematic relative to the increased incidence of stroke.¹

A migraine aura is visual 90% of the time.¹ Symptoms can include flickering lights, spots, zigzag lines, a sense of pins and needles, or dysphasic speech. Aura precedes the headache and usually resolves within 1 hour after the aura begins.

In addition to migraine headaches, risk factors for stroke include increasing age, hypertension, the use of combination oral contraceptives (COCs), the contraceptive patch and ring, and smoking.¹

Data indicate that the risk for ischemic stroke is increased in women with migraines even without the presence of other risk factors. In a meta-analysis of 14 observational studies, the risk of ischemic stroke among all migraineurs was about 2-fold (relative risk [RR], 2.2; 95% confidence interval [CI], 1.9–2.5) compared with the risk of ischemic stroke in women of the same age group who did not have migraine headaches. When there is migraine without aura, it was slightly less than 2-fold (RR, 1.8; 95% CI, 1.1–3.2). The risk of ischemic stroke among migraineurs with aura is increased more than 2 times compared with women without migraine (RR, 2.27; 95% CI, 1.61–3.19).³ However, the absolute risk of ischemic stroke among reproductive-aged women is 11 per 100,000 women years.⁴

Two observational studies show how additional risk factors increase that risk (TABLE).^5,6 There are similar trends in terms of overall risk of stroke among women with all types of migraine. However, when you add smoking as an additional risk factor for women with migraine headaches, there is a substantial increase in the risk of stroke. When a woman who has migraines uses COCs, there is increased risk varying from 2-fold to almost 4-fold. When you combine migraine, smoking, and COCs, a very, very large risk factor (odds ratio [OR], 34.4; 95% CI, 3.27–3.61) was reported by Chang and colleagues.⁶

Although these risks are impressive, it is important to keep in mind that even with a 10-fold increase, we are only talking about 1 case per 1,000 migraineurs.⁴ Unfortunately, stroke often leads to major disability and even death, such that any reduction in risk is still important.

Preventing estrogen withdrawal or menstrual migraines

How should we treat a woman who uses hormonal contraception and reports estrogen withdrawal or menstrual migraines? Based on clinical evidence, there are 2 ways to reduce her symptoms:

• COCs. Reduce the hormone-free interval by having her take COCs for 3 to 4 days instead of 7 days, or eliminate the hormone-free interval altogether by continuous use of COCs, usually 3 months at a time.⁷
• NSAIDs. For those who do not want to alter how they take their hormonal product, use nonsteroidal anti-inflammatory drugs (NSAIDs) starting 7 days before the onset of menses and continuing for 13 days. In a clinical trial by Sances and colleagues, this plan reduced the frequency, duration, and severity of menstrual migraines.⁸

Probably altering how she takes the COC would make the most sense for most individuals instead of taking NSAIDs for 75% of each month.

Recommendations from the US MEC

The US Medical Eligibility Criteria (US MEC) from the Centers for Disease Control and Prevention (CDC) offers recommendations for contraceptive use⁹:

• For nonmigrainous headache, the CDC suggests that the benefits of using COCs outweigh the risks unless the headaches persist after 3 months of COC use.

• For migraine without aura, the benefits outweigh the risks in starting women who are younger than age 35 years on oral contraceptives. However, the risks of COCs outweigh the benefits in women who are age 35 years and older who develop migraine headache while on COCs, or who have risk factors for stroke.

• For migraine with aura, COCs are contraindicated.
• Progestin-only contraceptives. The CDC considers that the benefits of COC use outweigh any theoretical risk of stroke, even in women with risk factors or in women who have migraine with aura. Progestin-only contraceptives do not alter one’s risk of stroke, unlike contraceptives that contain estrogen.

My bottom line

Can women with migraine headaches begin the use of combination hormonal methods? Yes, if there is no aura in their migraines and they are not older than age 35.

Can women with severe headaches that are nonmigrainous use combination hormonal methods? Possibly, but you should discontinue COCs if headache severity persists or worsens, using a 3-month time period for evaluation.

How do you manage women with migraines during the hormone-free interval? Consider the continuous method or shorten the hormone-free interval.

Recommendations for complicated patients. Consulting the CDC’s US MEC database⁷ can provide assistance in your care of more complicated patients requesting contraception. I also recommend the book, “Contraception for the Medically Challenging Patient,” edited by Rebecca Allen and Carrie Cwiak.¹⁰ It links nicely with the CDC guidelines and presents more detail on each subject.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Centers for Disease Control and Prevention (CDC) is a US federal agency under the Department of Health and Human Services. It is the nation’s leading public health institute. Its main goal is to save lives and protect people from health, safety, and security threats. The CDC website lists 25 no-cost applications that the agency has developed: https://www.cdc.gov/mobile/mobileapp.html.

This review will focus on 3 CDC apps (Table) that I feel are useful to ObGyn health care providers: Prevent Group B Strep (GBS), STD Tx Guide, and US Medical Eligibility Criteria for Contraceptive Use. In fact, in an evaluation of contraception apps for providers of family planning services, US Medical Eligibility Criteria for Contraceptive Use was one of the highest scoring apps.¹ I will evaluate each app by a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).² I commend the CDC for developing these useful tools to assist health care providers.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Centers for Disease Control and Prevention (CDC) is a US federal agency under the Department of Health and Human Services. It is the nation’s leading public health institute. Its main goal is to save lives and protect people from health, safety, and security threats. The CDC website lists 25 no-cost applications that the agency has developed: https://www.cdc.gov/mobile/mobileapp.html.

This review will focus on 3 CDC apps (Table) that I feel are useful to ObGyn health care providers: Prevent Group B Strep (GBS), STD Tx Guide, and US Medical Eligibility Criteria for Contraceptive Use. In fact, in an evaluation of contraception apps for providers of family planning services, US Medical Eligibility Criteria for Contraceptive Use was one of the highest scoring apps.¹ I will evaluate each app by a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).² I commend the CDC for developing these useful tools to assist health care providers.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Centers for Disease Control and Prevention (CDC) is a US federal agency under the Department of Health and Human Services. It is the nation’s leading public health institute. Its main goal is to save lives and protect people from health, safety, and security threats. The CDC website lists 25 no-cost applications that the agency has developed: https://www.cdc.gov/mobile/mobileapp.html.

This review will focus on 3 CDC apps (Table) that I feel are useful to ObGyn health care providers: Prevent Group B Strep (GBS), STD Tx Guide, and US Medical Eligibility Criteria for Contraceptive Use. In fact, in an evaluation of contraception apps for providers of family planning services, US Medical Eligibility Criteria for Contraceptive Use was one of the highest scoring apps.¹ I will evaluate each app by a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature use, and important special features).² I commend the CDC for developing these useful tools to assist health care providers.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The facts

Title X, a bill originally passed in 1970 under President Nixon, is the only federal grant program dedicated to providing family planning services as well as other preventive health care to primarily low-income patients. It is estimated that 70% of patients using Title X services are below the federal poverty level and more than 60% are uninsured or underinsured.¹

In 2015 alone, Title X clinics served 3.8 million women, preventing 822,300 unintended pregnancies and 277,800 abortions.² These clinics provide comprehensive family planning services including information, counseling, and referrals for abortion services. Title X clinics do not use the funding to provide abortion care, and no federal funding from Title X has ever been used to pay for abortions.

Proposed rule changes

The Trump Administration has proposed several new rules for Title X grant recipients.

Here are the main changes³:

• There must be a “financial and physical” separation between a clinic that is a Title X grant recipient and a facility where “abortion is a method of family planning.” This would prevent health centers that receive Title X funding from providing abortions at the same facility. This rule would predominantly affect health centers like Planned Parenthood. Although these clinics already have a financial separation from abortion care, there would not be a physical one in most situations and these clinics would lose Title X funding or be forced to stop providing abortion services.
• Providers who work at a clinic that receives Title X funding but provides abortions at a completely different facility may be ineligible for ongoing Title X grant money. In the new changes, “funds may not be used…to support the separate abortion business of Title X grant subrecipient.” The changes also propose to “protect Title X providers” from choosing between the health of their patients and their consciences. It plans to do this by removing the requirement to provide abortion counseling and referral and allows “non-directive” counseling.
• There would also be a requirement to encourage more parental involvement in minors’ decision making. While clinics already discuss parental involvement, the change would seek to increase the encouragement to young patients to involve parents. Most young patients do involve a parent or guardian in their care; however, many Title X clinics serve young patients who seek care confidentially. Patients seek confidential care due to a multitude of reasons, including history of abuse, lack of trust, and intimate partner violence.
• “A Title X project may not perform, promote, refer for, or support abortion as a method of family planning.” Although the rule does not prevent providers from discussing abortions, clinicians could offer little guidance if a patient opts for an abortion. Providers can give a list of “qualified, comprehensive health service providers” but may not disclose which, if any, of the providers perform abortions.

Take action

Title X provides important health care services to low-income, uninsured, and underinsured patients. These proposals put access to comprehensive health care for vulnerable populations at risk. Medical organizations including the American Medical Association and American College of Obstetricians and Gynecologists have made statements against the proposed changes to Title X. As ObGyns, we need to ensure our patients are fully informed and have access to all family planning and preventive health services.

Call or email your local representative and tell them you oppose the changes to Title X. Find your representatives here.

Follow ACOG’s Action Center on protecting Title X, which includes a flyer for your waiting room.

Send a message to the Health and Human Services Secretary. Submit a formal comment through July 31, 2018, on the Federal Registrar website expressing your thoughts with these proposed changes.

The facts

Title X, a bill originally passed in 1970 under President Nixon, is the only federal grant program dedicated to providing family planning services as well as other preventive health care to primarily low-income patients. It is estimated that 70% of patients using Title X services are below the federal poverty level and more than 60% are uninsured or underinsured.¹

In 2015 alone, Title X clinics served 3.8 million women, preventing 822,300 unintended pregnancies and 277,800 abortions.² These clinics provide comprehensive family planning services including information, counseling, and referrals for abortion services. Title X clinics do not use the funding to provide abortion care, and no federal funding from Title X has ever been used to pay for abortions.

Proposed rule changes

The Trump Administration has proposed several new rules for Title X grant recipients.

Here are the main changes³:

• There must be a “financial and physical” separation between a clinic that is a Title X grant recipient and a facility where “abortion is a method of family planning.” This would prevent health centers that receive Title X funding from providing abortions at the same facility. This rule would predominantly affect health centers like Planned Parenthood. Although these clinics already have a financial separation from abortion care, there would not be a physical one in most situations and these clinics would lose Title X funding or be forced to stop providing abortion services.
• Providers who work at a clinic that receives Title X funding but provides abortions at a completely different facility may be ineligible for ongoing Title X grant money. In the new changes, “funds may not be used…to support the separate abortion business of Title X grant subrecipient.” The changes also propose to “protect Title X providers” from choosing between the health of their patients and their consciences. It plans to do this by removing the requirement to provide abortion counseling and referral and allows “non-directive” counseling.
• There would also be a requirement to encourage more parental involvement in minors’ decision making. While clinics already discuss parental involvement, the change would seek to increase the encouragement to young patients to involve parents. Most young patients do involve a parent or guardian in their care; however, many Title X clinics serve young patients who seek care confidentially. Patients seek confidential care due to a multitude of reasons, including history of abuse, lack of trust, and intimate partner violence.
• “A Title X project may not perform, promote, refer for, or support abortion as a method of family planning.” Although the rule does not prevent providers from discussing abortions, clinicians could offer little guidance if a patient opts for an abortion. Providers can give a list of “qualified, comprehensive health service providers” but may not disclose which, if any, of the providers perform abortions.

Take action

Title X provides important health care services to low-income, uninsured, and underinsured patients. These proposals put access to comprehensive health care for vulnerable populations at risk. Medical organizations including the American Medical Association and American College of Obstetricians and Gynecologists have made statements against the proposed changes to Title X. As ObGyns, we need to ensure our patients are fully informed and have access to all family planning and preventive health services.

Call or email your local representative and tell them you oppose the changes to Title X. Find your representatives here.

Follow ACOG’s Action Center on protecting Title X, which includes a flyer for your waiting room.

Send a message to the Health and Human Services Secretary. Submit a formal comment through July 31, 2018, on the Federal Registrar website expressing your thoughts with these proposed changes.

The facts

Title X, a bill originally passed in 1970 under President Nixon, is the only federal grant program dedicated to providing family planning services as well as other preventive health care to primarily low-income patients. It is estimated that 70% of patients using Title X services are below the federal poverty level and more than 60% are uninsured or underinsured.¹

In 2015 alone, Title X clinics served 3.8 million women, preventing 822,300 unintended pregnancies and 277,800 abortions.² These clinics provide comprehensive family planning services including information, counseling, and referrals for abortion services. Title X clinics do not use the funding to provide abortion care, and no federal funding from Title X has ever been used to pay for abortions.

Proposed rule changes

The Trump Administration has proposed several new rules for Title X grant recipients.

Here are the main changes³:

• There must be a “financial and physical” separation between a clinic that is a Title X grant recipient and a facility where “abortion is a method of family planning.” This would prevent health centers that receive Title X funding from providing abortions at the same facility. This rule would predominantly affect health centers like Planned Parenthood. Although these clinics already have a financial separation from abortion care, there would not be a physical one in most situations and these clinics would lose Title X funding or be forced to stop providing abortion services.
• Providers who work at a clinic that receives Title X funding but provides abortions at a completely different facility may be ineligible for ongoing Title X grant money. In the new changes, “funds may not be used…to support the separate abortion business of Title X grant subrecipient.” The changes also propose to “protect Title X providers” from choosing between the health of their patients and their consciences. It plans to do this by removing the requirement to provide abortion counseling and referral and allows “non-directive” counseling.
• There would also be a requirement to encourage more parental involvement in minors’ decision making. While clinics already discuss parental involvement, the change would seek to increase the encouragement to young patients to involve parents. Most young patients do involve a parent or guardian in their care; however, many Title X clinics serve young patients who seek care confidentially. Patients seek confidential care due to a multitude of reasons, including history of abuse, lack of trust, and intimate partner violence.
• “A Title X project may not perform, promote, refer for, or support abortion as a method of family planning.” Although the rule does not prevent providers from discussing abortions, clinicians could offer little guidance if a patient opts for an abortion. Providers can give a list of “qualified, comprehensive health service providers” but may not disclose which, if any, of the providers perform abortions.

Take action

Title X provides important health care services to low-income, uninsured, and underinsured patients. These proposals put access to comprehensive health care for vulnerable populations at risk. Medical organizations including the American Medical Association and American College of Obstetricians and Gynecologists have made statements against the proposed changes to Title X. As ObGyns, we need to ensure our patients are fully informed and have access to all family planning and preventive health services.

Call or email your local representative and tell them you oppose the changes to Title X. Find your representatives here.

Follow ACOG’s Action Center on protecting Title X, which includes a flyer for your waiting room.

Send a message to the Health and Human Services Secretary. Submit a formal comment through July 31, 2018, on the Federal Registrar website expressing your thoughts with these proposed changes.

The Essure permanent birth control device will no longer be sold or distributed after Dec. 31, 2018, in the United States.

Bayer, the manufacturer of Essure, notified the Food and Drug Administration of its decision to halt U.S. sales of the device, Commissioner Scott Gottlieb, MD, announced July 20 in a press release. Dr. Gottlieb added that the agency would continue its commitment to postmarketing review of Essure. “We expect Bayer to meet its postmarket obligations concerning this device.”

Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide, the FDA release stated. The device has been associated with serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.

“In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction, which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgment that they fully understood these potential risks before having the device implanted. Since the FDA ordered Bayer to conduct the postmarket study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70% decline in sales of Essure in the United States,” Dr. Gottlieb said in the FDA press release. The company stated its decision to halt sales and distribution of the device was because of commercial reasons.

“Numerous adverse events ... were reported to the FDA, including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We’re continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”

In September 2015, the FDA convened an expert panel to examine and follow up on complaints from Essure users that included abdominal pain, abnormal uterine bleeding, and device migration. In February 2016, the FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The following October, the agency issued the final guidance, “Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization.” Soon thereafter, the FDA approved updated labeling for Essure that added a boxed warning and a Patient Decision Checklist.

In March 2018, the FDA reported a rise in new medical device reports submitted to the agency’s public database in 2017, with more than 90% of the reports involving potential device removal. The April restriction of sales and distribution was in response to concerns that not every patient was receiving adequate risk information.

“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Each study participant will be followed for a total of 3 years, and the company will continue to submit reports to the FDA on the study’s progress and results. Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we’ll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure,” Dr. Gottlieb stated.

He added that women who are using Essure successfully to prevent pregnancy should continue to do so, as “device removal has its own risks.”
 

[email protected]

The Essure permanent birth control device will no longer be sold or distributed after Dec. 31, 2018, in the United States.

Bayer, the manufacturer of Essure, notified the Food and Drug Administration of its decision to halt U.S. sales of the device, Commissioner Scott Gottlieb, MD, announced July 20 in a press release. Dr. Gottlieb added that the agency would continue its commitment to postmarketing review of Essure. “We expect Bayer to meet its postmarket obligations concerning this device.”

Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide, the FDA release stated. The device has been associated with serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.

“In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction, which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgment that they fully understood these potential risks before having the device implanted. Since the FDA ordered Bayer to conduct the postmarket study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70% decline in sales of Essure in the United States,” Dr. Gottlieb said in the FDA press release. The company stated its decision to halt sales and distribution of the device was because of commercial reasons.

“Numerous adverse events ... were reported to the FDA, including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We’re continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”

In September 2015, the FDA convened an expert panel to examine and follow up on complaints from Essure users that included abdominal pain, abnormal uterine bleeding, and device migration. In February 2016, the FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The following October, the agency issued the final guidance, “Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization.” Soon thereafter, the FDA approved updated labeling for Essure that added a boxed warning and a Patient Decision Checklist.

In March 2018, the FDA reported a rise in new medical device reports submitted to the agency’s public database in 2017, with more than 90% of the reports involving potential device removal. The April restriction of sales and distribution was in response to concerns that not every patient was receiving adequate risk information.

“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Each study participant will be followed for a total of 3 years, and the company will continue to submit reports to the FDA on the study’s progress and results. Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we’ll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure,” Dr. Gottlieb stated.

He added that women who are using Essure successfully to prevent pregnancy should continue to do so, as “device removal has its own risks.”
 

[email protected]

The Essure permanent birth control device will no longer be sold or distributed after Dec. 31, 2018, in the United States.

Bayer, the manufacturer of Essure, notified the Food and Drug Administration of its decision to halt U.S. sales of the device, Commissioner Scott Gottlieb, MD, announced July 20 in a press release. Dr. Gottlieb added that the agency would continue its commitment to postmarketing review of Essure. “We expect Bayer to meet its postmarket obligations concerning this device.”

Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide, the FDA release stated. The device has been associated with serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.

“In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction, which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgment that they fully understood these potential risks before having the device implanted. Since the FDA ordered Bayer to conduct the postmarket study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70% decline in sales of Essure in the United States,” Dr. Gottlieb said in the FDA press release. The company stated its decision to halt sales and distribution of the device was because of commercial reasons.

“Numerous adverse events ... were reported to the FDA, including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We’re continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”

In September 2015, the FDA convened an expert panel to examine and follow up on complaints from Essure users that included abdominal pain, abnormal uterine bleeding, and device migration. In February 2016, the FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The following October, the agency issued the final guidance, “Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization.” Soon thereafter, the FDA approved updated labeling for Essure that added a boxed warning and a Patient Decision Checklist.

In March 2018, the FDA reported a rise in new medical device reports submitted to the agency’s public database in 2017, with more than 90% of the reports involving potential device removal. The April restriction of sales and distribution was in response to concerns that not every patient was receiving adequate risk information.

“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Each study participant will be followed for a total of 3 years, and the company will continue to submit reports to the FDA on the study’s progress and results. Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we’ll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure,” Dr. Gottlieb stated.

He added that women who are using Essure successfully to prevent pregnancy should continue to do so, as “device removal has its own risks.”
 

[email protected]

Although IUDs are effective as emergency contraception, few young women knew about this use of the device, according to a recent, multisite survey published in Contraception.

Only 7.5% of young female participants in a recent study had heard that the IUD could be used for emergency contraception (EC), according to a cluster-randomized trial of 1,500 women aged 18-25 years receiving contraception counseling at 40 U.S. Planned Parenthood centers. Race, ethnicity, and insurance status had no effect on the likelihood that a woman would know about IUDs as EC.

However, the study found, 68% of women surveyed would want to know about IUD use for EC, and those for whom a pregnancy would cause the most unhappiness were especially likely to want to know about this option (adjusted odds ratio, 1.26; 95% confidence interval, 1.01-1.58; P = .04). Again, demographic factors did not affect the likelihood that women would want to know about the IUD as an alternative to EC pills.

“In this 40-site U.S. study of sexually active young women, very few had heard of the IUD as a form of EC or knew of its significantly higher efficacy compared to EC pills, but most would desire to learn about it if they needed EC,” wrote Suzan Goodman, MD, MPH, and her coauthors.

Office visits where women request EC “provide a unique and time-sensitive opportunity to prevent an unwanted pregnancy, as well as to offer ongoing contraception,” wrote Dr. Goodman of the University of California, San Francisco, and her coauthors. But previous work showed that teens and young women are not generally well-informed about EC, including the window of effectiveness and methods that can be used for EC.

Dr. Goodman and her collaborators conducted a secondary analysis of a cluster-randomized trial that delivered a 4-hour training module to half of the Planned Parenthood centers; the evidence-based training focused on contraceptive counseling, long-acting reversible contraception, and IUD placement. Patients seen at the 40 centers were surveyed before receiving contraception counseling, and at 3 and 6 months post counseling.

Participant assignment to a center where the intervention had been administered to clinic staff had no bearing on how likely they were to have heard that IUDs could be used as EC.

Of the original survey respondents, who were young women not intending to become pregnant for at least 12 months, a total of 1,138 participants completed the relevant portions of the survey. The mean age of the respondents was 21.5 years, and were mostly (94%) never married. About one-quarter (26%) had private insurance, 31% had public insurance, and 38% were uninsured. About half were white, one-quarter were black, and 17% identified as Hispanic.

Study participants were very likely to view a doctor or nurse as their most trusted sources of information about EC, with 91% identifying this source over the Internet (6%) or friends (2%). Previous work, Dr. Goodman and her colleagues wrote, has found that women are more likely to consider an IUD if they had heard about it from a health care provider.

Although incorporating the ability to place an IUD at an EC visit may present some challenges in terms of clinic work flow and staff training, it’s an option that should be considered for many reasons, the authors noted.

IUDs are overall more effective than EC pills, with marked advantages in some instances: IUDs have higher efficacy in women with obesity, for women who have had multiple episodes of intercourse within the 5-day efficacy window, and for women at the fertile point of their menstrual cycles. Once inserted, they afford the additional advantage of ongoing protection against pregnancy.

“Contraceptive education should explicitly address IUD as EC,” wrote Dr. Goodman and her coauthors. “A coordinated effort to improve counseling, provider training, and same-day access to IUD as EC will be critical to offering women their full range of contraceptive options.”

This study was funded by the William and Flora Hewlett Foundation and the National Institutes of Health. Dr. Goodman reported no conflicts of interest. Two study coauthors are employees of Planned Parenthood, which participates in unrelated studies funded by HRA Pharma.

[email protected]

SOURCE: Goodman S et al. Contraception. 2018 Apr 18. doi: 10.1016/j.contraception.2018.04.009.

Although IUDs are effective as emergency contraception, few young women knew about this use of the device, according to a recent, multisite survey published in Contraception.

Only 7.5% of young female participants in a recent study had heard that the IUD could be used for emergency contraception (EC), according to a cluster-randomized trial of 1,500 women aged 18-25 years receiving contraception counseling at 40 U.S. Planned Parenthood centers. Race, ethnicity, and insurance status had no effect on the likelihood that a woman would know about IUDs as EC.

However, the study found, 68% of women surveyed would want to know about IUD use for EC, and those for whom a pregnancy would cause the most unhappiness were especially likely to want to know about this option (adjusted odds ratio, 1.26; 95% confidence interval, 1.01-1.58; P = .04). Again, demographic factors did not affect the likelihood that women would want to know about the IUD as an alternative to EC pills.

“In this 40-site U.S. study of sexually active young women, very few had heard of the IUD as a form of EC or knew of its significantly higher efficacy compared to EC pills, but most would desire to learn about it if they needed EC,” wrote Suzan Goodman, MD, MPH, and her coauthors.

Office visits where women request EC “provide a unique and time-sensitive opportunity to prevent an unwanted pregnancy, as well as to offer ongoing contraception,” wrote Dr. Goodman of the University of California, San Francisco, and her coauthors. But previous work showed that teens and young women are not generally well-informed about EC, including the window of effectiveness and methods that can be used for EC.

Dr. Goodman and her collaborators conducted a secondary analysis of a cluster-randomized trial that delivered a 4-hour training module to half of the Planned Parenthood centers; the evidence-based training focused on contraceptive counseling, long-acting reversible contraception, and IUD placement. Patients seen at the 40 centers were surveyed before receiving contraception counseling, and at 3 and 6 months post counseling.

Participant assignment to a center where the intervention had been administered to clinic staff had no bearing on how likely they were to have heard that IUDs could be used as EC.

Of the original survey respondents, who were young women not intending to become pregnant for at least 12 months, a total of 1,138 participants completed the relevant portions of the survey. The mean age of the respondents was 21.5 years, and were mostly (94%) never married. About one-quarter (26%) had private insurance, 31% had public insurance, and 38% were uninsured. About half were white, one-quarter were black, and 17% identified as Hispanic.

Study participants were very likely to view a doctor or nurse as their most trusted sources of information about EC, with 91% identifying this source over the Internet (6%) or friends (2%). Previous work, Dr. Goodman and her colleagues wrote, has found that women are more likely to consider an IUD if they had heard about it from a health care provider.

Although incorporating the ability to place an IUD at an EC visit may present some challenges in terms of clinic work flow and staff training, it’s an option that should be considered for many reasons, the authors noted.

IUDs are overall more effective than EC pills, with marked advantages in some instances: IUDs have higher efficacy in women with obesity, for women who have had multiple episodes of intercourse within the 5-day efficacy window, and for women at the fertile point of their menstrual cycles. Once inserted, they afford the additional advantage of ongoing protection against pregnancy.

“Contraceptive education should explicitly address IUD as EC,” wrote Dr. Goodman and her coauthors. “A coordinated effort to improve counseling, provider training, and same-day access to IUD as EC will be critical to offering women their full range of contraceptive options.”

This study was funded by the William and Flora Hewlett Foundation and the National Institutes of Health. Dr. Goodman reported no conflicts of interest. Two study coauthors are employees of Planned Parenthood, which participates in unrelated studies funded by HRA Pharma.

[email protected]

SOURCE: Goodman S et al. Contraception. 2018 Apr 18. doi: 10.1016/j.contraception.2018.04.009.

Although IUDs are effective as emergency contraception, few young women knew about this use of the device, according to a recent, multisite survey published in Contraception.

Only 7.5% of young female participants in a recent study had heard that the IUD could be used for emergency contraception (EC), according to a cluster-randomized trial of 1,500 women aged 18-25 years receiving contraception counseling at 40 U.S. Planned Parenthood centers. Race, ethnicity, and insurance status had no effect on the likelihood that a woman would know about IUDs as EC.

However, the study found, 68% of women surveyed would want to know about IUD use for EC, and those for whom a pregnancy would cause the most unhappiness were especially likely to want to know about this option (adjusted odds ratio, 1.26; 95% confidence interval, 1.01-1.58; P = .04). Again, demographic factors did not affect the likelihood that women would want to know about the IUD as an alternative to EC pills.

“In this 40-site U.S. study of sexually active young women, very few had heard of the IUD as a form of EC or knew of its significantly higher efficacy compared to EC pills, but most would desire to learn about it if they needed EC,” wrote Suzan Goodman, MD, MPH, and her coauthors.

Office visits where women request EC “provide a unique and time-sensitive opportunity to prevent an unwanted pregnancy, as well as to offer ongoing contraception,” wrote Dr. Goodman of the University of California, San Francisco, and her coauthors. But previous work showed that teens and young women are not generally well-informed about EC, including the window of effectiveness and methods that can be used for EC.

Dr. Goodman and her collaborators conducted a secondary analysis of a cluster-randomized trial that delivered a 4-hour training module to half of the Planned Parenthood centers; the evidence-based training focused on contraceptive counseling, long-acting reversible contraception, and IUD placement. Patients seen at the 40 centers were surveyed before receiving contraception counseling, and at 3 and 6 months post counseling.

Participant assignment to a center where the intervention had been administered to clinic staff had no bearing on how likely they were to have heard that IUDs could be used as EC.

Of the original survey respondents, who were young women not intending to become pregnant for at least 12 months, a total of 1,138 participants completed the relevant portions of the survey. The mean age of the respondents was 21.5 years, and were mostly (94%) never married. About one-quarter (26%) had private insurance, 31% had public insurance, and 38% were uninsured. About half were white, one-quarter were black, and 17% identified as Hispanic.

Study participants were very likely to view a doctor or nurse as their most trusted sources of information about EC, with 91% identifying this source over the Internet (6%) or friends (2%). Previous work, Dr. Goodman and her colleagues wrote, has found that women are more likely to consider an IUD if they had heard about it from a health care provider.

Although incorporating the ability to place an IUD at an EC visit may present some challenges in terms of clinic work flow and staff training, it’s an option that should be considered for many reasons, the authors noted.

IUDs are overall more effective than EC pills, with marked advantages in some instances: IUDs have higher efficacy in women with obesity, for women who have had multiple episodes of intercourse within the 5-day efficacy window, and for women at the fertile point of their menstrual cycles. Once inserted, they afford the additional advantage of ongoing protection against pregnancy.

“Contraceptive education should explicitly address IUD as EC,” wrote Dr. Goodman and her coauthors. “A coordinated effort to improve counseling, provider training, and same-day access to IUD as EC will be critical to offering women their full range of contraceptive options.”

This study was funded by the William and Flora Hewlett Foundation and the National Institutes of Health. Dr. Goodman reported no conflicts of interest. Two study coauthors are employees of Planned Parenthood, which participates in unrelated studies funded by HRA Pharma.

[email protected]

SOURCE: Goodman S et al. Contraception. 2018 Apr 18. doi: 10.1016/j.contraception.2018.04.009.

Researchers have highlighted the need for contraception counseling for transgender men, after a study found around half of transgender men had not been asked by their health care providers about their fertility desires.

Writing in Contraception, researchers reported the results of an anonymous, online survey of 197 female-to-male transgender men, 86% of whom were taking masculinizing hormones.

Overall, 17% of respondents had experienced a pregnancy, with 60 pregnancies reported in total. While participants who had never taken hormones had a nearly 200% higher incidence of pregnancy, compared with those who had taken testosterone, one pregnancy occurred while the subject was taking testosterone, and five of seven reported abortions were in participants who had used testosterone prior to conception.

A total of 30 participants (16.4%) believed testosterone was a contraceptive method, and 10 said that a health care provider had advised them to use testosterone for contraception. However, nearly half of all participants did report using condoms for contraception, making it the most common method. IUDs were the second most common method of contraception currently used.

Nearly one-third of participants said they had used some type of contraceptive pill at some point, 17 said they had tried more than one type of pill, and 36 had used combination pills. However, of those who had used combination pills, nearly half stopped using them because of side effects or because of concern about extra feminine hormones.

The authors noted that most study participants expressed a desire to become a parent. Around one-quarter wanted to bear a child while the majority said they would consider adoption.

One-quarter of respondents had fears about not achieving a desired pregnancy, and for some, those fears began after initiating hormone treatments. Just over half the respondents said their health care provider had not asked about their fertility desires.

“Transgender men have unintended pregnancy as well as future fertility desires, and yet, there is a paucity of reproductive health care best practices research for this unique population,” wrote Alexis Light, MD, MPH, of MedStar Washington Hospital Center, and her coauthors. “This survey confirms earlier studies: Transgender men do become pregnant, both intentionally and unintentionally, and some transgender men engage in behaviors that can lead to unintended pregnancy.”

The study authors called for doctors to be more equipped and prepared to counsel transgender men on contraception and discuss other reproductive health concerns.

The study was supported by MedStar Washington Hospital Center. No conflicts of interest were declared.

SOURCE: Light A et al. Contraception. 2018 Jun 23. doi: 10.1016/j.contraception.2018.06.006.

Researchers have highlighted the need for contraception counseling for transgender men, after a study found around half of transgender men had not been asked by their health care providers about their fertility desires.

Writing in Contraception, researchers reported the results of an anonymous, online survey of 197 female-to-male transgender men, 86% of whom were taking masculinizing hormones.

Overall, 17% of respondents had experienced a pregnancy, with 60 pregnancies reported in total. While participants who had never taken hormones had a nearly 200% higher incidence of pregnancy, compared with those who had taken testosterone, one pregnancy occurred while the subject was taking testosterone, and five of seven reported abortions were in participants who had used testosterone prior to conception.

A total of 30 participants (16.4%) believed testosterone was a contraceptive method, and 10 said that a health care provider had advised them to use testosterone for contraception. However, nearly half of all participants did report using condoms for contraception, making it the most common method. IUDs were the second most common method of contraception currently used.

Nearly one-third of participants said they had used some type of contraceptive pill at some point, 17 said they had tried more than one type of pill, and 36 had used combination pills. However, of those who had used combination pills, nearly half stopped using them because of side effects or because of concern about extra feminine hormones.

The authors noted that most study participants expressed a desire to become a parent. Around one-quarter wanted to bear a child while the majority said they would consider adoption.

One-quarter of respondents had fears about not achieving a desired pregnancy, and for some, those fears began after initiating hormone treatments. Just over half the respondents said their health care provider had not asked about their fertility desires.

“Transgender men have unintended pregnancy as well as future fertility desires, and yet, there is a paucity of reproductive health care best practices research for this unique population,” wrote Alexis Light, MD, MPH, of MedStar Washington Hospital Center, and her coauthors. “This survey confirms earlier studies: Transgender men do become pregnant, both intentionally and unintentionally, and some transgender men engage in behaviors that can lead to unintended pregnancy.”

The study authors called for doctors to be more equipped and prepared to counsel transgender men on contraception and discuss other reproductive health concerns.

The study was supported by MedStar Washington Hospital Center. No conflicts of interest were declared.

SOURCE: Light A et al. Contraception. 2018 Jun 23. doi: 10.1016/j.contraception.2018.06.006.

Researchers have highlighted the need for contraception counseling for transgender men, after a study found around half of transgender men had not been asked by their health care providers about their fertility desires.

Writing in Contraception, researchers reported the results of an anonymous, online survey of 197 female-to-male transgender men, 86% of whom were taking masculinizing hormones.

Overall, 17% of respondents had experienced a pregnancy, with 60 pregnancies reported in total. While participants who had never taken hormones had a nearly 200% higher incidence of pregnancy, compared with those who had taken testosterone, one pregnancy occurred while the subject was taking testosterone, and five of seven reported abortions were in participants who had used testosterone prior to conception.

A total of 30 participants (16.4%) believed testosterone was a contraceptive method, and 10 said that a health care provider had advised them to use testosterone for contraception. However, nearly half of all participants did report using condoms for contraception, making it the most common method. IUDs were the second most common method of contraception currently used.

Nearly one-third of participants said they had used some type of contraceptive pill at some point, 17 said they had tried more than one type of pill, and 36 had used combination pills. However, of those who had used combination pills, nearly half stopped using them because of side effects or because of concern about extra feminine hormones.

The authors noted that most study participants expressed a desire to become a parent. Around one-quarter wanted to bear a child while the majority said they would consider adoption.

One-quarter of respondents had fears about not achieving a desired pregnancy, and for some, those fears began after initiating hormone treatments. Just over half the respondents said their health care provider had not asked about their fertility desires.

“Transgender men have unintended pregnancy as well as future fertility desires, and yet, there is a paucity of reproductive health care best practices research for this unique population,” wrote Alexis Light, MD, MPH, of MedStar Washington Hospital Center, and her coauthors. “This survey confirms earlier studies: Transgender men do become pregnant, both intentionally and unintentionally, and some transgender men engage in behaviors that can lead to unintended pregnancy.”

The study authors called for doctors to be more equipped and prepared to counsel transgender men on contraception and discuss other reproductive health concerns.

The study was supported by MedStar Washington Hospital Center. No conflicts of interest were declared.

SOURCE: Light A et al. Contraception. 2018 Jun 23. doi: 10.1016/j.contraception.2018.06.006.