Contraception

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception

Major finding:  A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37). 

Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905. 

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.

Major finding:  Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.

Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women

Major finding:  Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.

Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.  

Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.

Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.

Major finding:  Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.

Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring. 

Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.

Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.

Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs copper intrauterine devices for emergency contraception. N Engl J Med. 2021;384:335-344.

EXPERT COMMENTARY

Emergency contraception refers to therapies used to prevent pregnancy after inadequately protected intercourse.¹ Evidence-based forms of EC available in the United States include oral LNG, oral ulipristal acetate, and the copper IUD. The copper IUD provides not only EC but also highly effective contraception after placement.² The LNG-IUD has a favorable side effect profile compared with the copper IUD and is theorized to act as EC through direct interference with sperm and oviduct transport.³ Recently, Turok and colleagues conducted a noninferiority trial designed to investigate the EC effectiveness of the LNG-IUD compared with the copper IUD.³

Details of the study

Turok and colleagues recruited participants aged 18 to 35 who requested EC from 6 family planning clinics in Utah from 2016 to 2019. Participants who reported unprotected intercourse within the past 120 hours and who desired an IUD to prevent pregnancy for at least 1 year were randomly assigned to receive either the LNG-IUD or the copper IUD. Individuals were excluded from the trial if they had contraindications to IUD placement, were breastfeeding, had abnormal uterine bleeding, had irregular menses, were currently using highly effective contraception, or had recent EC use. Researchers determined pregnancy status at 1 month through a pregnancy test or clinical records review.

Results. Of 711 participants randomly assigned, 317 who received the LNG-IUD and 321 who received the copper IUD provided 1-month outcome data. Pregnancy 1 month after IUD placement occurred in 1 participant (0.3%) in the LNG-IUD group and in no participants in the copper IUD group (0%). The between-group difference of 0.3 percentage points was within the margin of noninferiority and was not significant.

Study strengths and limitations

This large, multicenter randomized controlled trial contributes novel information about the effectiveness and noninferiority of the LNG-IUD as EC. Unlike prior studies of oral EC, which commonly limited participants to 1 episode of unprotected intercourse, this trial enrolled women at potentially higher risk of pregnancy with multiple episodes of intercourse and found fewer pregnancies than expected. Randomization ensured equivalence between groups, with the exception of the reason for needing EC.

Study limitations include a higher than expected rate of loss to follow-up, requiring clinical records and survey data to confirm pregnancy status. After randomization, clinicians were unable to place IUDs in more than 5% of participants in both groups; noninferiority was demonstrated nonetheless. This study did not include participants receiving oral EC, so direct comparison of effectiveness is not possible. Pregnancy rates among IUD users in this study were favorable to rates reported in previous studies of oral EC.⁴

When choosing an IUD for contraception, more women select the LNG-IUD for its favorable side effect profile and reduction in menstrual bleeding. In this randomized IUD study, only 7% of eligible participants enrolled, potentially introducing selection bias. The majority who declined enrollment did not want an IUD. Previous studies that allowed participants to choose their IUD had higher enrollment rates. ● 

Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs copper intrauterine devices for emergency contraception. N Engl J Med. 2021;384:335-344.

EXPERT COMMENTARY

Emergency contraception refers to therapies used to prevent pregnancy after inadequately protected intercourse.¹ Evidence-based forms of EC available in the United States include oral LNG, oral ulipristal acetate, and the copper IUD. The copper IUD provides not only EC but also highly effective contraception after placement.² The LNG-IUD has a favorable side effect profile compared with the copper IUD and is theorized to act as EC through direct interference with sperm and oviduct transport.³ Recently, Turok and colleagues conducted a noninferiority trial designed to investigate the EC effectiveness of the LNG-IUD compared with the copper IUD.³

Details of the study

Turok and colleagues recruited participants aged 18 to 35 who requested EC from 6 family planning clinics in Utah from 2016 to 2019. Participants who reported unprotected intercourse within the past 120 hours and who desired an IUD to prevent pregnancy for at least 1 year were randomly assigned to receive either the LNG-IUD or the copper IUD. Individuals were excluded from the trial if they had contraindications to IUD placement, were breastfeeding, had abnormal uterine bleeding, had irregular menses, were currently using highly effective contraception, or had recent EC use. Researchers determined pregnancy status at 1 month through a pregnancy test or clinical records review.

Results. Of 711 participants randomly assigned, 317 who received the LNG-IUD and 321 who received the copper IUD provided 1-month outcome data. Pregnancy 1 month after IUD placement occurred in 1 participant (0.3%) in the LNG-IUD group and in no participants in the copper IUD group (0%). The between-group difference of 0.3 percentage points was within the margin of noninferiority and was not significant.

Study strengths and limitations

This large, multicenter randomized controlled trial contributes novel information about the effectiveness and noninferiority of the LNG-IUD as EC. Unlike prior studies of oral EC, which commonly limited participants to 1 episode of unprotected intercourse, this trial enrolled women at potentially higher risk of pregnancy with multiple episodes of intercourse and found fewer pregnancies than expected. Randomization ensured equivalence between groups, with the exception of the reason for needing EC.

Study limitations include a higher than expected rate of loss to follow-up, requiring clinical records and survey data to confirm pregnancy status. After randomization, clinicians were unable to place IUDs in more than 5% of participants in both groups; noninferiority was demonstrated nonetheless. This study did not include participants receiving oral EC, so direct comparison of effectiveness is not possible. Pregnancy rates among IUD users in this study were favorable to rates reported in previous studies of oral EC.⁴

When choosing an IUD for contraception, more women select the LNG-IUD for its favorable side effect profile and reduction in menstrual bleeding. In this randomized IUD study, only 7% of eligible participants enrolled, potentially introducing selection bias. The majority who declined enrollment did not want an IUD. Previous studies that allowed participants to choose their IUD had higher enrollment rates. ● 

Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs copper intrauterine devices for emergency contraception. N Engl J Med. 2021;384:335-344.

EXPERT COMMENTARY

Emergency contraception refers to therapies used to prevent pregnancy after inadequately protected intercourse.¹ Evidence-based forms of EC available in the United States include oral LNG, oral ulipristal acetate, and the copper IUD. The copper IUD provides not only EC but also highly effective contraception after placement.² The LNG-IUD has a favorable side effect profile compared with the copper IUD and is theorized to act as EC through direct interference with sperm and oviduct transport.³ Recently, Turok and colleagues conducted a noninferiority trial designed to investigate the EC effectiveness of the LNG-IUD compared with the copper IUD.³

Details of the study

Turok and colleagues recruited participants aged 18 to 35 who requested EC from 6 family planning clinics in Utah from 2016 to 2019. Participants who reported unprotected intercourse within the past 120 hours and who desired an IUD to prevent pregnancy for at least 1 year were randomly assigned to receive either the LNG-IUD or the copper IUD. Individuals were excluded from the trial if they had contraindications to IUD placement, were breastfeeding, had abnormal uterine bleeding, had irregular menses, were currently using highly effective contraception, or had recent EC use. Researchers determined pregnancy status at 1 month through a pregnancy test or clinical records review.

Results. Of 711 participants randomly assigned, 317 who received the LNG-IUD and 321 who received the copper IUD provided 1-month outcome data. Pregnancy 1 month after IUD placement occurred in 1 participant (0.3%) in the LNG-IUD group and in no participants in the copper IUD group (0%). The between-group difference of 0.3 percentage points was within the margin of noninferiority and was not significant.

Study strengths and limitations

This large, multicenter randomized controlled trial contributes novel information about the effectiveness and noninferiority of the LNG-IUD as EC. Unlike prior studies of oral EC, which commonly limited participants to 1 episode of unprotected intercourse, this trial enrolled women at potentially higher risk of pregnancy with multiple episodes of intercourse and found fewer pregnancies than expected. Randomization ensured equivalence between groups, with the exception of the reason for needing EC.

Study limitations include a higher than expected rate of loss to follow-up, requiring clinical records and survey data to confirm pregnancy status. After randomization, clinicians were unable to place IUDs in more than 5% of participants in both groups; noninferiority was demonstrated nonetheless. This study did not include participants receiving oral EC, so direct comparison of effectiveness is not possible. Pregnancy rates among IUD users in this study were favorable to rates reported in previous studies of oral EC.⁴

When choosing an IUD for contraception, more women select the LNG-IUD for its favorable side effect profile and reduction in menstrual bleeding. In this randomized IUD study, only 7% of eligible participants enrolled, potentially introducing selection bias. The majority who declined enrollment did not want an IUD. Previous studies that allowed participants to choose their IUD had higher enrollment rates. ● 

Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.

Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.

“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.

Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.

For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.

Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.

Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”

“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”

This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.

Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.

“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.

Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.

Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.

Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.

“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.

Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.

For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.

Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.

Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”

“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”

This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.

Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.

“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.

Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.

Telehealth abortion may be just as safe and effective as in-person care, according to a small study published online in JAMA Network Open.

Of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.

“There was no reason to expect that the medications prescribed [via telemedicine] and delivered through the mail would have different outcomes from when a patient traveled to a clinic,” study author Ushma D. Upadhyay, PhD, MPH, associate professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, said in an interview.

Medication abortion, which usually involves taking mifepristone (Mifeprex) followed by misoprostol (Cytotec) during the first 10 weeks of pregnancy, has been available in the United States since 2000. The Food and Drug Administration’s Risk Evaluation and Mitigation Strategy requires that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies in an effort to reduce potential risk for complications.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic. However, Dr. Upadhyay hopes the findings of her current study will make this suspension permanent.

For the study, Dr. Upadhyay and colleagues examined the safety and efficacy of fully remote, medication abortion care. Eligibility for the medication was assessed using an online form that relies on patient history, or patients recalling their last period, to assess pregnancy duration and screen for ectopic pregnancy risks. Nurse practitioners reviewed the form and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography. A mail-order pharmacy delivered medications to eligible patients. The protocol involved three follow-up contacts: confirmation of medication administration, a 3-day assessment of symptoms, and a home pregnancy test after 4 weeks. Follow-up interactions were conducted by text, secure messaging, or telephone.

Researchers found that in addition to the 95% of the patients having a complete abortion without intervention, 5% (five) of patients required addition medical care to complete the abortion. Two of those patients were treated in EDs.

Gillian Burkhardt, MD, who was not involved in the study, said Dr. Upadhyay’s study proves what has been known all along, that medication is super safe and that women “can help to determine their own eligibility as well as in conjunction with the provider.”

“I hope that this will be one more study that the FDA can use when thinking about changing the risk evaluation administration strategy so that it’s removing the requirement that a person be in the dispensing medical office,” Dr. Burkhardt, assistant professor of family planning in the department of obstetrics & gynecology at the University of New Mexico Hospital, Albuquerque, said in an interview. “I hope it also makes providers feel more comfortable as well, because I think there’s some hesitancy among providers to provide abortion without doing an ultrasound or without seeing the patient typically in front of them.”

This isn’t the first study to suggest the safety of telemedicine abortion. A 2019 study published in Obstetrics & Gynecology, which analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person at 26 Planned Parenthood health centers in four states found that ongoing pregnancy and aspiration procedures were less common among telemedicine patients. Another 2017 study published in BMJ found that women who used an online consultation service and self-sourced medical abortion during a 3-year period were able to successfully end their pregnancies with few adverse events.

Dr. Upadhyay said one limitation of the current study is its sample size, so more studies should be conducted to prove telemedicine abortion’s safety.

“I think that we need continued research on this model of care just so we have more multiple studies that contribute to the evidence that can convince providers as well that they don’t need a lot of tests and that they can mail,” Dr. Upadhyay said.

Neither Dr. Upadhyay nor Dr. Burkhardt reported conflicts of interests.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Women with sickle cell disease report high rates of unplanned pregnancy and limited knowledge and use of long-acting reversible contraception despite the high-risk nature of pregnancy for sickle cell disease patients.

Major finding:  In a survey of 78 women with sickle cell disease, 73% had an average of 2.5 pregnancies, and 58% reported unplanned pregnancies. The most frequently reported contraception in the study population was condoms (87%), followed by birth control pills (46%), medroxyprogesterone (44%), and withdrawal (44%), while 22% reported use of long-acting reversible contraception.

Study details: The data come from a survey of 78 women aged 28-65 years with sickle cell disease seen at a single adult and pediatric sickle cell treatment center.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Pecker LH et al. J Natl Med Assoc. 2021 Jun 9. doi: 10.1016/j.jnma.2021.05.005.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: Cesarean delivery was independently associated with missing strings and expulsion of an IUD placed after delivery.

Major finding:  Among women who underwent postplacental copper IUD placement, missing strings were noted in 47.9% 34.2% of women at postpartum visits 1 and 2, respectively, and 8.9% experience expulsions by visit 2. Cesarean delivery was associated with a significantly increased risk of missing strings, but a decreased risk of IUD expulsion (adjusted risk ratios 6.21 and 0.24, respectively). 

Study details: The data come from 705 women who underwent postplacental insertion of a copper T380A IUD. The women were assessed at postpartum visits at 45-90 days and again at 6-9 months.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Barboza da Silva Nobrega A et al. Int J Gynaecol Obstet. 2021 Jul 1. doi: 10.1002/ijgo.13806.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.