[Efficacy and safety of misoprostol in obstetrics]

To review the efficacy and safety of misoprostol for indications not included in the prescription information given for the product, including abortion, labor induction, treatment and prevention of postpartum bleeding, and hysteroscopy preparation.

Pubmed was searched for controlled, randomized, blinded clinical trials of misoprostol in obstetrics from 1999 through 2004.

Nineteen clinical trials were found. The efficacy for abortion in association with mifepristone at a dosage of 400 microg/6 h is superior versus both placebo and gemeprost, but misoprostol is more painful and less effective than dilation and subsequent evacuation. Regarding the administration route, trials show similar efficacy for the vaginal and oral approaches. In the prevention and treatment of postpartum hemorrhage, misoprostol was not any better than oxytocin. When used as a labor inducing agent, results are best with doses of 50 microg/3-8 h, but no controlled clinical trials were found. Although its use for hysteroscopy facilitates the procedure versus placebo, it entails a higher frequency of adverse events. No controlled clinical trials were found for other options.

The efficacy of misoprostol for indications reviewed in this paper is controversial, and studies found are heterogeneous. Designing and conducting further clinical trials to investigate appropriate dosage and administration routes, as well as the drug s adverse effect profile under such circumstances is essential, and would potentially allow an application for approval to be filed with health authorities regarding its use in obstetric practice.