Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.
“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.
“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”
In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.
Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.
The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.
A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.
Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.
Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).
“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”
The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
Data support self-management medication abortion later in pregnancy
“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.
“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”
Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.
“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key.
“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
Rising rate of self-managed abortions highlights need for more data
“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”
courtesy University of Washington
Dr. Lauren Owens
Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.
The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”
According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”
According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”
“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”
The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.