A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation

Hum Reprod. 2003 Nov;18(11):2315-8. doi: 10.1093/humrep/deg475.


Background: A combination of mifepristone and misoprostol provides an effective method of medical abortion for early pregnancy. This is the first randomized trial comparing the use of sublingual misoprostol with vaginal misoprostol in combination with mifepristone for termination of early pregnancies up to 63 days.

Methods: A total of 224 women who requested legal termination of pregnancy up to 63 days were randomized by computer- generated list into two groups and given 200 mg of oral mifepristone followed 48 h later by either 800 micro g of sublingual (n = 112) or vaginal (n = 112) misoprostol.

Results: Complete abortion occurred in 98.2% (95% CI: 93-99) of women in the sublingual group and 93.8% (95% CI: 88-97) in the vaginal group. There were three ongoing pregnancies in the vaginal group but none in the sublingual group. The median duration of vaginal bleeding was 17 days. There was no serious complication. Fever, chills and gastrointestinal side-effects (nausea, vomiting and diarrhoea) were significantly more common in the sublingual group.

Conclusions: The combination of mifepristone and misoprostol is effective for medical abortion up to 63 days. Both the sublingual and vaginal are effective routes of administration. Further randomized trials are required to find out the optimal dose of sublingual misoprostol that can give the highest complete abortion rate and lowest incidence of side-effects.

Publication types

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

MeSH terms

  • Abortifacient Agents, Nonsteroidal / administration & dosage*
  • Abortifacient Agents, Nonsteroidal / adverse effects
  • Abortifacient Agents, Steroidal / adverse effects
  • Abortifacient Agents, Steroidal / therapeutic use*
  • Abortion, Induced*
  • Administration, Intravaginal
  • Administration, Sublingual
  • Adult
  • Drug Therapy, Combination
  • Female
  • Humans
  • Mifepristone / adverse effects
  • Mifepristone / therapeutic use*
  • Misoprostol / administration & dosage*
  • Misoprostol / adverse effects
  • Placebos
  • Pregnancy
  • Pregnancy Trimester, First
  • Treatment Outcome


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