The World Health Organization recommends either mifepristone in combination with misoprostol or misoprostol alone for abortion, but clinical evidence has indicated misoprostol alone has an effectiveness of 80% compared to 95% for mifepristone alongside misoprostol.
Misoprostol alone can be used as an effective abortion method, according to a recent study published in JAMA Network Open.1
The World Health Organization recommends either mifepristone in combination with misoprostol or misoprostol alone for abortion, but clinical evidence has indicated misoprostol alone has an effectiveness of 80% compared to 95% for mifepristone alongside misoprostol. This has led the combination method to be preferred for abortion in many countries.
Misoprostol alone is used in areas where mifepristone cannot be used, with advantages including a low cost, availability in many settings without a prescription, multiple indications, shelf stability, and ease of administration. This has led to a rise in misoprostol use for self-managed abortion worldwide.
As research on misoprostol alone has focused on determining the recommended dosing and administration routes, there is little data on the effectiveness of currently endorsed misoprostol-alone protocols. Investigators conducted a study to determine the safety and efficacy of misoprostol alone for abortion.
Data was obtained from callers to safe abortion hotlines, with eligible callers from July 31, 2019, to October 1, 2020, included in the analysis. Recruitment sites discussed abortion options in detail, including instructions for taking abortion medications, assessing medication eligibility, navigating the health care system, and determining completion.
Eligibility criteria included being aged 13 years or older, having no contraindications to medication abortion, not currently bleeding, and contacting an included accompaniment group for information on starting a medication abortion protocol. Participants completed questionnaires at baseline and at 1 and 3 weeks after taking medications.
Effectiveness was defined by study authors as, “abortion completion without procedural intervention.” This was the primary outcome of the analysis, determined by questions included in the follow-up questionnaires.
Safety was included as a secondary outcome, measured based on potential warning signs and adverse events. Additional outcomes included regimen dosing details, initiation and duration of bleeding and cramping, time to expulsion, adverse events, and health care-seeking experiences.
There were 637 participants included in the final analysis, 92.8% of which were from Nigeria, 7.1% Southeast Asia, and 0.2% from Argentina. Of participants, 60.2% were aged 20 to 29 years, 97.2% had completed secondary school or higher, and 96.9% confirmed their pregnancy through a pregnancy test.
A pregnancy duration of under 7 weeks when taking the first misoprostol dose was reported in 49.8% of participants, 7 to under 9 weeks in 32.2%, and 9 weeks or longer in 18%. The standard misoprostol-alone regimen of800 μg misoprostol taken 3 times, with 3 hours between each dose, was taken by 83.5% of participants.
A complete abortion at the first follow-up was reported by 95.3% of participants. This rate rose to 98.6% of participants at the second follow-up. Participants using the currently endorsed regimen had increased efficacy compared to those using a different regimen. All pregnancy durations had high efficacy at the last follow-up.
At least some bleeding was reported in 99.4% of participants, often starting after the second or third dose. Bleeding lasting under 7 days was reported by 76.2% of participants, and 87.3% reported 1 to 3 days of heavy bleeding. Common adverse effects included nausea, fever, diarrhea, and chills.
These results indicated efficacy from misoprostol-alone for abortions. Investigators concluded evidence-based methods for medication abortion may help ensure people can access abortion care when necessary.