Efficacy, Safety, and Acceptability of Low-Dose Mifepristone and Self-Administered Misoprostol for Ultra-Early Medical Abortion: A Randomized Controlled Trial

Reprod Sci. 2017 May;24(5):731-737. doi: 10.1177/1933719116669055. Epub 2016 Sep 27.


The aim of this study was to investigate the efficacy, safety, and acceptability of low-dose mifepristone combined with self-administered misoprostol for ultra-early medical abortion. A total of 744 women with ultra-early pregnancy (amenorrhea ≤35 days) who fulfilled the inclusion criteria were enrolled in the study. Equal numbers of participants were allocated randomly to the hospital administration and self-administration groups. All participants took 75 mg mifepristone at the initial visit and 400 µg oral misoprostol 24 hours later in the hospital or by self-administration. The primary end point was complete abortion. Secondary end points were rates of unscheduled reattendance, time required for and cost of hospital observation and follow-up, vaginal bleeding, adverse effects, menstrual disturbance in the posttreatment period, and satisfaction rating. No differences in the rates of complete abortion, unscheduled reattendance, vaginal bleeding, adverse effects, or return of posttreatment menstruation were observed. The time required for (and costs of) hospital observation and follow-up per participant was 557.82 minutes (and US$40.12) in the hospital administration group and 18.46 minutes (and US$1.96) in the self-administration group (both P < .001). Satisfaction rates were similar in both groups, but the rates of "very satisfied" responses (87.60% vs 25.41%) and follow-up compliance (loss to follow-up, 0.45% vs 7.70%) were higher in the self-administration group (both P < .001). Low-dose mifepristone combined with self-administered misoprostol for ultra-early pregnancy termination was as effective and safe as hospital administration, with greater acceptability and lower cost to the women.

Keywords: medical abortion; mifepristone; misoprostol; self-administration; ultra-early pregnancy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abortifacient Agents / administration & dosage*
  • Abortifacient Agents / adverse effects
  • Abortion, Induced / methods*
  • Administration, Oral
  • Adult
  • Drug Therapy, Combination
  • Female
  • Humans
  • Mifepristone / administration & dosage*
  • Mifepristone / adverse effects
  • Misoprostol / administration & dosage*
  • Misoprostol / adverse effects
  • Pregnancy
  • Pregnancy Trimester, First
  • Self Administration
  • Treatment Outcome
  • Young Adult


  • Abortifacient Agents
  • Misoprostol
  • Mifepristone