SAFE study shows the effectiveness of misoprostol alone regimens for medication abortion are higher than previously reported in clinical trials
SAFE Study Highlights:
- Self-managed abortion (SMA) with medications is very safe and effective:
93.8% of those who used the mifepristone + misoprostol regimen had a complete abortion without surgical intervention.
98.8% of those who used the misoprostol-alone regimen had a complete abortion without surgical intervention.
- SMA with medication is no less effective than clinician-managed medication abortion in a clinical setting, for pregnancies <9 weeks duration.
- No deaths or major adverse events took place among SAFE study participants.
Cambridge, MA, November 18, 2021 – Today, the Studying Accompaniment Model Feasibility and Effectiveness (SAFE) study was published in The Lancet Global Health. Safe abortion advocates at Colectiva Feminista La Revuelta de Neuquén (Argentina), GIWYN (Nigeria), and in Southeast Asia, together with researchers at Ibis Reproductive Health (South Africa and USA), designed and implemented the SAFE study.
The SAFE study, the first study of its kind, recruited over 1,000 people who contacted a safe abortion accompaniment group in Argentina or Nigeria, followed them for approximately one month, and measured outcomes on their self-managed abortion experiences, with abortion completion without surgical intervention as the primary outcome.
Self-managed medication abortion involves the use of one of two medication regimens to end a pregnancy without clinical supervision recommended by the World Health Organization (WHO). The WHO-recommended medication regimens of mifepristone in combination with misoprostol, or misoprostol alone, are established safe and effective methods of terminating pregnancy in clinical settings. A self-managed abortion with accompaniment involves non-clinically trained abortion counselors who provide evidence-based information about the use of medication abortion, as well as compassionate emotional (and sometimes physical support), throughout an individual’s self-managed medication abortion process. Abortion accompaniment is provided over the phone, through secure digital messaging platforms, and/or in person.
“There is a misconception that self-managed abortion may somehow be unsafe, or less effective than clinician-managed medication abortion—this is simply untrue. The SAFE study definitively demonstrates that self-managed medication abortion is no less effective than clinician-managed medication abortion using both mifepristone + misoprostol as well as misoprostol alone,” said Heidi Moseson, PhD, Senior Research Scientist at Ibis Reproductive Health and lead author of the SAFE study. “The greatest risks today for people self-managing their abortions are legal, such as criminalization and arrest, not medical. These data support the fact that governments, professional bodies, and clinicians should remove legal and procedural barriers to self-managed abortion.”
The SAFE study reinforces an existing body of evidence that, with accurate information, people can safely and effectively use medications to terminate a pregnancy outside of a clinical setting. These findings provide evidence for the demedicalization of early abortion care and support the importance of continued access to remote models for medication abortion—including telemedicine—that have been implemented in several countries as a result of the COVID-19 pandemic. Results from this study also suggest that SMA with support from accompaniment support can be a core strategy for expanding access to safe, effective abortion care.
###
Media Contact
Suniti Sarah Bal: suniti.bal@gmmb.com