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Volume 328:1509-1513 May 27, 1993 Number 21 Next

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ABSTRACT

Background and Methods The combination of mifepristone (RU 486) and a prostaglandin analogue given either intramuscularly or intravaginally is effective in terminating early pregnancy, but the prostaglandin component of the regimen is cumbersome to administer and has side effects. We conducted two studies to determine the efficacy of 600 mg of mifepristone followed by a small dose of misoprostol, an orally active prostaglandin E₁ analogue, for the same purpose. In the first study, 505 women who had had amenorrhea for less than 50 days received 400 µg of misoprostol 48 hours after receiving mifepristone, if the pregnancy was not terminated within that period. In the second study, 390 women initially received the same treatment, but if the pregnancy was not terminated within four hours after the administration of misoprostol, they were offered an additional 200-µg dose of misoprostol.

Results In study 1, the rate of success (termination of pregnancy and complete expulsion of the conceptus) was 96.9 percent (95 percent confidence interval, 94.1 to 97.7 percent) -- similar to the success rate of approximately 95 percent for mifepristone followed by the intramuscular or intravaginal administration of prostaglandin. Abortion occurred in 2.9 percent of the women within 48 hours after the administration of mifepristone, in 60.9 percent within 4 hours after the administration of misoprostol, and in 33.2 percent thereafter. The failures included ongoing pregnancies in four women (0.8 percent) and incomplete abortions in nine (1.8 percent); two other women (0.4 percent) required vacuum aspiration for prolonged uterine bleeding. In study 2, pregnancy was terminated in 5.5 percent of the women before the administration of misoprostol and within four hours after the first dose of misoprostol in 69.1 percent. Among the 71 women who received a second dose of misoprostol, 67 had complete abortions, 2 had partial retention of the conceptus, 1 had synechia with ongoing pregnancy, and 1 had an ectopic pregnancy. One ongoing pregnancy, which was terminated by vacuum aspiration, was recorded among the 27 women who declined to take the second dose of misoprostol. The overall rate of success of the regimen with the optional second dose of misoprostol was 98.7 percent (95 percent confidence interval, 96.8 to 99.5 percent). No woman had any serious adverse event.

Conclusions The combination of mifepristone and misoprostol is effective for the termination of early pregnancy in terms of success, tolerance, safety, and practicality.

Source Information

From the Medical Department, Laboratoires Roussel, Paris (R.P., V.T., L.S., M.R., F.E., A.U.); the Centre d'Orthogenie de l'Hopital Broussais, Service du Pr. P. Poitout, Paris (E.A.); and the Institut National de la Sante et de la Recherche Medicale (INSERM) U33 and the Laboratoire d'Hormonologie de l'Hopital de Bicetre, Bicetre (P.L., E.-E.B.) -- all in France.

Address reprint requests to Dr. Baulieu at INSERM U33 and Laboratoire des Hormones, 80 rue du General Leclerc, 94276 Le Kremlin-Bicetre, France.

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