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Previous Volume 342:534-540 February 24, 2000 Number 8 Next

	Full Text PDF Editorial by Lamont, R. F. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Bacterial vaginosis has been associated with preterm birth. In clinical trials, the treatment of bacterial vaginosis in pregnant women who previously had a preterm delivery reduced the risk of recurrence.

Methods To determine whether treating women in a general obstetrical population who have asymptomatic bacterial vaginosis (as diagnosed on the basis of vaginal Gram's staining and pH) prevents preterm delivery, we randomly assigned 1953 women who were 16 to less than 24 weeks pregnant to receive two 2-g doses of metronidazole or placebo. The diagnostic studies were repeated and a second treatment was administered to all the women at 24 to less than 30 weeks' gestation. The primary outcome was the rate of delivery before 37 weeks' gestation.

Results Bacterial vaginosis resolved in 657 of 845 women who had follow-up Gram's staining in the metronidazole group (77.8 percent) and 321 of 859 women in the placebo group (37.4 percent). Data on the time and characteristics of delivery were available for 953 women in the metronidazole group and 966 in the placebo group. Preterm delivery occurred in 116 women in the metronidazole group (12.2 percent) and 121 women in the placebo group (12.5 percent) (relative risk, 1.0; 95 percent confidence interval, 0.8 to 1.2). Treatment did not prevent preterm deliveries that resulted from spontaneous labor (5.1 percent in the metronidazole group vs. 5.7 percent in the placebo group) or spontaneous rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it prevent delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with metronidazole did not reduce the occurrence of preterm labor, intraamniotic or postpartum infections, neonatal sepsis, or admission of the infant to the neonatal intensive care unit.

Conclusions The treatment of asymptomatic bacterial vaginosis in pregnant women does not reduce the occurrence of preterm delivery or other adverse perinatal outcomes.

Source Information

From the Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City (J.C.C.); the National Institute of Child Health and Human Development, Bethesda, Md. (M.A.K., R.P.N.); the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham (J.C.H.); the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh (S.L.H., R.P.H.); the Biostatistics Center, George Washington University, Rockville, Md. (E.A.T., M.L.F.); the Department of Obstetrics and Gynecology, Wake Forest University School of Medicine, Winston-Salem, N.C. (J.M.E.); the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas (K.J.L.); the Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia (R.W.); and the Department of Obstetrics and Gynecology, University of Utah, Salt Lake City (M.V.). Other authors were Wayne Trout, M.D., Department of Obstetrics and Gynecology, Ohio State University, Columbus; Atef Moawad, M.D., Department of Obstetrics and Gynecology, University of Chicago, Chicago; Baha M. Sibai, M.D., Department of Obstetrics and Gynecology, University of Tennessee, Memphis; Menachem Miodovnik, M.D., Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati; Mitchell Dombrowski, M.D., Department of Obstetrics and Gynecology, Wayne State University, Detroit; Mary J. O'Sullivan, M.D., Department of Obstetrics and Gynecology, University of Miami, Miami; J. Peter VanDorsten, M.D., Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston; Oded Langer, M.D., Department of Obstetrics and Gynecology, University of Texas at San Antonio, San Antonio; and James Roberts, M.D., Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh.Presented at the annual meeting of the Society for Maternal–Fetal Medicine, San Francisco, January 21–23, 1999.

Address reprint requests to Dr. Klebanoff at NICHD, NIH, 6100 Executive Blvd., Rm. 7B03 MSC 7510, Bethesda, MD 20892-7510, or at mk90h{at}nih.gov.

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