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Previous Volume 353:761-769 August 25, 2005 Number 8 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Winikoff, B. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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

Full Text of this Article

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:

• Reeves, M. F., Lohr, P. A., Harwood, B. J., Creinin, M. D. (2008). Ultrasonographic Endometrial Thickness After Medical and Surgical Management of Early Pregnancy Failure. Obstet Gynecol 111: 106-112 [Abstract] [Full Text]  
• Lillquist, E., Sullivan, C. A. (2006). Legal Regulation of the Use of Race in Medical Research. J Law Med Ethics 34: 535-551  
• Weeks, A., Danielsson, K. G. (2006). Spontaneous miscarriage in the first trimester.. BMJ 332: 1223-1224 [Full Text]  
• Trinder, J, Brocklehurst, P, Porter, R, Read, M, Vyas, S, Smith, L (2006). Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ 332: 1235-1240 [Abstract] [Full Text]  
• Creinin, M. D., Huang, X., Westhoff, C., Barnhart, K., Gilles, J. M., Zhang, J., for the National Institute of Child Health and Hum, (2006). Factors Related to Successful Misoprostol Treatment for Early Pregnancy Failure.. Obstet Gynecol 107: 901-907 [Abstract] [Full Text]  
• 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 Gr, (2005). Medical vs. surgical management of early pregnancy failure.. NEJM 353: 2403-2404 [Full Text]  
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• Winikoff, B. (2005). Pregnancy Failure and Misoprostol -- Time for a Change. NEJM 353: 834-836 [Full Text]