A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy

Hum Reprod. 2002 Jun;17(6):1477-82. doi: 10.1093/humrep/17.6.1477.


Background: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy.

Methods: 250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration.

Results: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05).

Conclusions: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Abortifacient Agents, Nonsteroidal / administration & dosage*
  • Abortifacient Agents, Nonsteroidal / adverse effects
  • Abortifacient Agents, Steroidal / administration & dosage*
  • Abortifacient Agents, Steroidal / adverse effects
  • Abortion, Induced / methods*
  • Administration, Intravaginal
  • Administration, Oral
  • Adult
  • Double-Blind Method
  • Drug Synergism
  • Female
  • Humans
  • Mifepristone / administration & dosage*
  • Mifepristone / adverse effects
  • Misoprostol / administration & dosage*
  • Misoprostol / adverse effects
  • Nausea / chemically induced
  • Pregnancy
  • Prospective Studies


  • Abortifacient Agents, Nonsteroidal
  • Abortifacient Agents, Steroidal
  • Misoprostol
  • Mifepristone