Pregnancy outcome after exposure to misoprostol in Brazil: A prospective, controlled study

Background: Misoprostol, a synthetic prostaglandin E1 analog is labeled for the treatment of gastric and duodenal ulcers, In Brazil, where abortion is not a legal procedure, there is a widespread popular misuse of this drug i n abortion attempts. This misuse and the fact that, in many cases the desir ed pregnancy termination does not occur, raise concerns about fetal safety. Case reports of congenital anomalies after maternal use of misoprostol hav e been published. The objective of this work was to compare pregnancy outco me following misoprostol exposure with a matched control group, This is the first prospective controlled study on fetal safety after misoprostol use. Methods: A prospective, observational cohort study with 86 exposed and 86 p air-matched, non-exposed controls. Results: There was no significant differ ence in the rates of major or minor birth between exposed compared to non-e xposed infants (2/67 vs 2/81, major defects; 7/67 vs. 3/81, minor anomalies ) There were significantly more miscarriages in the exposed group (17.1% vs , 5.8%; relative risk, 2.97; 95% confidence interval, 1.12 to 7.88), There was no statistical difference in gestational age at delivery, birth weight, sex ratio, rate of prematurity, low birth weight, or rates of cesarean sec tion between groups. Conclusions: Our study, despite its limited statistica l power, does not suggest a potent teratogenic action of misoprostol exposu re during pregnancy. (C) 1999 Elsevier Science Inc.