Induction of Labor: The Misoprostol Controversy


  • Alisa B. Goldberg MD, MPH,

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    • Alisa B. Goldberg, MD, MPH, is an Assistant Professor of Obstetrics and Gynecology and Reproductive Biology at Brigham and Women's Hospital, Harvard Medical School, Boston, MA. She is also the Associate Medical Director of Planned Parenthood League of Massachusetts, Boston, MA.

  • Deborah A. Wing MD

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    • Deborah A. Wing, MD, is an Associate Professor of Obstetrics and Gynecology at the University of Southern California, Keck School of Medicine, Los Angeles, CA. She is also Medical Director of Maternal-Fetal Medicine at Good Samaritan Hospital, Los Angeles, CA.

3Address correspondence to Dr. Alisa B. Goldberg, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, 75 Francis Street, PB-5-506, Boston, MA 02115.


Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy. In August 2000, the manufacturer of misoprostol warned against its use in pregnancy because of its abortifacient properties and cited reports of maternal and fetal deaths when misoprostol was used to induce labor, fueling the misoprostol controversy. More than 45 randomized trials including more than 5400 women have found vaginal misoprostol to be more effective than oxytocin or vaginal prostaglandin E2 at effecting vaginal delivery within 24 hours. Cesarean delivery rates with vaginal misoprostol are lower than with oxytocin alone, but similar to prostaglandin E2. There have been no significant differences in the frequency of serious adverse maternal or neonatal outcomes with low-dose misoprostol compared with oxytocin or prostaglandin E2; however, the relative risk of rare adverse outcomes with misoprostol is unknown. The data suggest that absolute risks are low when misoprostol is used appropriately. We recommend 25 mcg vaginally every 4 to 6 hours for carefully selected patients in closely monitored settings. Whether misoprostol will prove to be the most cost-effective agent for inducing labor in women with an unfavorable cervix remains to be determined.