Highlighting the safety and effectiveness of the misoprostol-only medication abortion regimen

Ibis Reproductive Health
3 min readOct 31, 2023

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Medication abortion with misoprostol-only is one of two safe, highly effective, WHO-recommended regimens for medication abortion. Our SAFE Study and other findings support a renewed look at misoprostol-only regimens for medication abortion, no longer as a second-tier method, but one that offers similar effectiveness, and often greater accessibility, than the mifepristone + misoprostol regimen.

The currently recommended regimen for misoprostol-only for pregnancies 12 weeks or less is 800μg sublingually or vaginally every three hours for 3–4 doses.

Research on misoprostol-only

Ibis research shows that misoprostol-only is highly effective, and more effective than previously thought. Offering misoprostol-only medication abortion alongside combined regimens can further support and expand medication abortion access in the United States, as well as globally.

The Studying Accompaniment Feasibility and Effectiveness (SAFE) study was a prospective observational cohort study conducted in 2019 and 2020 with callers to safe abortion hotlines and accompaniment groups in Argentina, Nigeria, and a country in Southeast Asia. Safe abortion hotlines and accompaniment groups provide evidence-based counseling and person-centered support throughout a person’s self-managed medication abortion experience. You can learn more about these models of care on the SAFE Study website.

According to data from the SAFE Study, 93.8% of those who used the mifepristone + misoprostol regimen had a complete abortion without surgical intervention, while 98.8% of those who used the misoprostol-only regimen had a complete abortion without surgical intervention. Findings from the first study on self-managed abortion with misoprostol only in the United States reflect this data, with 88% overall effectiveness and 97.8% effectiveness among known outcomes.

A recent analysis by Ibis researchers assessed the abortion completion, symptoms, side effects, warning signs, and potential adverse events specifically among the 637 SAFE study participants who reported taking misoprostol-only for medication abortion. 95% of these participants reported their abortion complete without surgical intervention at approximately one week, and 98% at three weeks. The study also affirmed the safety of self-managed abortion using misoprostol-only: 98.9% of those who used the misoprostol-only regimen reported experiencing no potential adverse events.

Moreover, study findings about side effects, bleeding, and other symptoms experienced by SAFE study participants can inform patient information forms and counseling protocols to ensure people using the misoprostol-only regimen for medication abortion have accurate information about what to expect.

“If people are having a misoprostol-alone abortion, having that information about what to expect can be really important in making sure that people are well prepared for their overall abortion experience,” author and Ibis Research Scientist Ruvani Jayaweera told MedPage Today.

Access to abortion is critical for bodily autonomy and people’s ability to control their lives and futures. Everyone should have access to the full range of abortion care options. In the face of increasingly severe restrictions on access to mifepristone in the US and internationally, accurate and up-to-date guidance on the effectiveness of the misoprostol-only regimen, as well as an understanding of potential side effects and patient experiences, is more important than ever.

Additional Resources

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Ibis Reproductive Health

Global research and advocacy org advancing sexual and reproductive autonomy, choices, and health worldwide. #IbisDrivesChange