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Recommendations for Use of Misoprostol in Pregnant Women

Misoprostol, a prostaglandin E₁ analogue, is marketed for oral use to prevent and treat gastric ulcers associated with nonsteroidal anti-inflammatory drugs. This drug also has uterotonic and cervical-ripening actions and plays an important role in the care of women undergoing induced abortion and induction of labor (see JWWH Oct 1996, p. 80 and Contraception 1998; 58:1; JWWH Jan 2001, p. 5 and Obstet Gynecol 2000; 96:890). With oral administration of misoprostol (it's available in 100-µg unscored and 200-µg scored tablets), nausea, vomiting, diarrhea, abdominal pain, chills, shivering, and fever occur on a dose-dependent basis. With vaginal administration of the tablets, reproductive-tract effects are enhanced and gastrointestinal adverse effects are minimized. According to the package labeling, misoprostol is contraindicated in pregnant women because of its abortifacient properties, and the manufacturer recently sent a letter to physicians nationwide warning against its use during pregnancy.

After conducting a literature review, these authors used the U.S. Preventive Services Task Force guidelines to grade the strength of their recommendations regarding use of misoprostol in various pregnancy-related conditions. Detailed below are the indications and regimens that were given a strength of A, which indicates that good and consistent scientific evidence supports the recommendation.

Medical abortion at 56 or fewer days' gestation: 800 µg of misoprostol should be administered vaginally 36 to 48 hours after 200 mg of oral mifepristone, or 5 to 7 days after 50 mg of intramuscular or oral methotrexate per square meter of body surface area.

Cervical ripening before first trimester surgical abortion: 400 µg of misoprostol should be administered vaginally 3 to 4 hours before suction curettage.

Induction of labor in a third trimester pregnancy with a viable fetus: 25 µg of misoprostol should be administered vaginally every 4 to 6 hours. Clinicians should be aware that, compared with alternate approaches to labor induction, use of misoprostol is more likely to cause uterine hyperstimulation with associated changes in the fetal heart rate.

Comment: As the authors point out, misoprostol has become an important medication in the care of pregnant patients. Package labeling notwithstanding, good and consistent evidence supports the uses of misoprostol detailed above. Based on these data, which were derived from an extensive body of published literature, clinicians should continue to use misoprostol in specified pregnancy-related conditions.

— AM Kaunitz

Published in Journal Watch Women's Health February 19, 2001

Citation(s):

Goldberg AB et al. Drug therapy: Misoprostol and pregnancy. N Engl J Med 2001 Jan 4 344 38-47.

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