|
|
Background Misoprostol is increasingly used to treat women who have a failed pregnancy in the first trimester. We assessed the efficacy, safety, and acceptability of this treatment in a large, randomized trial.
Methods A total of 652 women with a first-trimester pregnancy failure (anembryonic gestation, embryonic or fetal death, or incomplete or inevitable spontaneous abortion) were randomly assigned to receive 800 µg of misoprostol vaginally or to undergo vacuum aspiration (standard of care) in a 3:1 ratio. The misoprostol group received treatment on day 1, a second dose on day 3 if expulsion was incomplete, and vacuum aspiration on day 8 if expulsion was still incomplete. Surgical treatment (for the misoprostol group) or repeated aspiration (for the vacuum-aspiration group) within 30 days after the initial treatment constituted treatment failure.
Results Of the 491 women assigned to receive misoprostol, 71 percent had complete expulsion by day 3 and 84 percent by day 8 (95 percent confidence interval, 81 to 87 percent). Treatment failed in 16 percent of the misoprostol group and 3 percent of the surgical group (absolute difference, 12 percent; 95 percent confidence interval, 9 to 16 percent) by day 30. Hemorrhage or endometritis requiring hospitalization was rare (1 percent or less in each group), with no significant differences between the groups. In the misoprostol group, 78 percent of the women stated that they would use misoprostol again if the need arose and 83 percent stated that they would recommend it to others.
Conclusions Treatment of early pregnancy failure with 800 µg of misoprostol vaginally is a safe and acceptable approach, with a success rate of approximately 84 percent.
Source Information
From the National Institute of Child Health and Human Development, Bethesda, Md. (J.Z.); the University of Miami, Miami (J.M.G.); the University of Pennsylvania, Philadelphia (K.B.); the University of Pittsburgh, Pittsburgh (M.D.C.); Columbia University, New York (C.W.); and Clinical Trials and Surveys Corporation, Baltimore (M.M.F.).
Address reprint requests to Dr. Zhang at the Epidemiology Branch, NICHD, NIH, Bldg. 6100, Rm. 7B03, Bethesda, MD 20892, or at zhangj{at}mail.nih.gov
Related Letters:
Medical vs. Surgical Management of Early Pregnancy Failure
Shukunami K.-i., Nishijima K., Kotsuji F., Grotegut C. A., Dandolu V., Zhang J., Creinin M. D., Barnhart K., the Management of Early Pregnancy Failure Trial Group
Extract |
Full Text |
PDF
N Engl J Med 2005;
353:2403-2404, Dec 1, 2005.
Correspondence
This article has been cited by other articles:
HOME | SUBSCRIBE | SEARCH | CURRENT ISSUE | PAST ISSUES | COLLECTIONS | PRIVACY | TERMS OF USE | HELP | beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2009 Massachusetts Medical Society. All rights reserved. |
Previous
