At-home misoprostol administration during second trimester safe, reduces time in hospital

Key takeaways:

• Women who received first misoprostol dose between 12 and 22 weeks’ gestation at home vs. in hospital had a higher proportion of completed abortions within 9 hours.
• Satisfaction and adverse events were similar for both groups.

At-home first-dose misoprostol administration increased the proportion of women completing medical abortion after 12 weeks’ gestation through outpatient care with a favorable safety profile, according to findings published in The Lancet.

“Currently, most abortions after 12 weeks of pregnancy take place in hospitals and may require an overnight stay, which some women find stressful and isolating. Our trial results show that taking the first dose of misoprostol at home decreases the average time women spent in hospital, enabling them to leave the hospital within 9 hours after admission and without an overnight stay,” Johanna Rydelius, MD, of the department of gynecology and obstetrics at the University of Gothenburg in Sweden, said in a related press release. “Offering the choice to take the first dose of misoprostol at home provides a safe and effective alternative to taking all misoprostol doses at hospital and enables women to self-manage some of the process, potentially leading to feelings of autonomy during a time where women can feel extremely vulnerable.”

The PRIMA trial

Rydelius and colleagues conducted the PRIMA trial, a multicenter, open-label, randomized controlled trial, with 435 pregnant women (mean age, 31 years) undergoing medical abortion during the second trimester of pregnancy recruited from six hospitals in Sweden from 2019 to 2022. Researchers randomly assigned participants mifepristone 200 mg in-clinic, followed by first misoprostol 800 µg dose 24 to 48 hours after either by home administration 2 hours before hospital admission (n = 220) or via hospital administration (n = 215).

Primary outcome was the proportion of completed abortions within 9 hours.

Among women who received first misoprostol dose at home, 71% completed abortion within 9 hours compared with 46% of women who received first misoprostol dose in hospital (P < .0001). Mean time spent in hospital was 10.3 hours for women in the home group and 13.1 hours for women in the hospital group.

Researchers observed no detectable difference between groups for induction to fetal abortion interval, completed abortion rate at 24 hours or mean number of misoprostol doses used until abortion. Satisfaction was also similar between groups with 86% of women in the home group and 81% in the hospital group very satisfied with treatment. More women in the home group preferred their allocated administration vs. the hospital group (78% vs. 49%; P < .0001).

Two women in the home group and five in the hospital group aborted before hospital admission. All abortions occurred 24 to 48 hours after mifepristone administration.

Overall, 21% of women in the home group and 23% in the hospital group experienced an adverse event from time of mifepristone administration until follow-up. The most common adverse event reported was heavy vaginal bleeding. In addition, 3% of women in the home group and 3% in the hospital group experienced a serious adverse event.

“Our study found 1% of the women who took misoprostol at home completed the abortion before attending hospital for the next dose. Previous studies suggest a 1% complete abortion rate within 2 hours after the misoprostol first dose, and women who took misoprostol at home were made aware of this risk when choosing to take part in the trial and provided with a number to call if they had any concerns,” Rydelius said in the release. “It’s extremely important that women who are given the choice to take the first dose of misoprostol at home are clearly informed about the very small risk of the abortion occurring before attending the hospital.”

At-home administration benefits

In an accompanying comment piece, Heidi Moseson, PhD, MPH, senior research scientist at Ibis Reproductive Health, and Caitlin Gerdts, PhD, MHS, epidemiologist at Ibis Reproductive Health, noted that shifting clinical protocols to allow at-home administration of first misoprostol dose could increase the number of same-day clinician-supported abortions for pregnancies 12 and 22 weeks’ gestation, which could expand abortion care, reduce burdens and promote task sharing for lesser costs. According to the authors, this may potentially reduce financial burdens experienced when obtaining abortion care later in pregnancy and extend the time in which women having abortions may be in a more comfortable or familiar environment with familial support.

“The PRIMA trial therefore contributes rigorous evidence towards the development of less clinically supervised approaches to medical abortion care after 12 weeks’ gestation, with the potential to improve access to abortion later in pregnancy,” the authors wrote.

References:

• Managing early stages of abortion care at home after 12 weeks of pregnancy is safe and reduces time spent in hospital, study finds. Published Aug. 29, 2024. Accessed Aug. 29, 2024.
• Moseson H, et al. Lancet. 2024;doi:10.1016/S0140-6736(24)01127-9.