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Previous Volume 345:487-493 August 16, 2001 Number 7 Next

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ABSTRACT

Background Infection with Trichomonas vaginalis during pregnancy has been associated with preterm delivery. It is uncertain whether treatment of asymptomatic trichomoniasis in pregnant women reduces the occurrence of preterm delivery.

Methods We screened pregnant women for trichomoniasis by culture of vaginal secretions. We randomly assigned 617 women with asymptomatic trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g doses of metronidazole (320 women) or placebo (297 women) 48 hours apart. We treated women again with the same two-dose regimen at 24 to 29 weeks of gestation. The primary outcome was delivery before 37 weeks of gestation.

Results Between randomization and follow-up, trichomoniasis resolved in 249 of 269 women for whom follow-up cultures were available in the metronidazole group (92.6 percent) and 92 of 260 women with follow-up cultures in the placebo group (35.4 percent). Data on the time and characteristics of delivery were available for 315 women in the metronidazole group and 289 women in the placebo group. Delivery occurred before 37 weeks of gestation in 60 women in the metronidazole group (19.0 percent) and 31 women in the placebo group (10.7 percent) (relative risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004). The difference was attributable primarily to an increase in preterm delivery resulting from spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative risk, 3.0; 95 percent confidence interval, 1.5 to 5.9).

Conclusions Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended.

Source Information

From 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 Oklahoma, Oklahoma City (J.C.C.); 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.); 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, Thomas Jefferson University, Philadelphia (R.J.W.); the Department of Obstetrics and Gynecology, Ohio State University, Columbus (W.T.); the Department of Obstetrics and Gynecology, University of Chicago, Chicago (A.M.); and the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas (K.J.L.).

Other authors were Menachem Miodovnik, M.D., Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati; Baha M. Sibai, M.D., Department of Obstetrics and Gynecology, University of Tennessee, Memphis; J. Peter Van Dorsten, M.D., Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston; Mitchell P. 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; Michael Varner, M.D., Department of Obstetrics and Gynecology, University of Utah, Salt Lake City; Oded Langer, M.D., Department of Obstetrics and Gynecology, University of Texas, San Antonio; Donald McNellis, M.D., National Institute of Child Health and Human Development, Bethesda, Md.; and James M. Roberts, M.D., Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh.

Address reprint requests to Dr. Klebanoff at the National Institute of Child Health and Human Development, 6100 Executive Blvd., Rm. 7B05, MSC 7510, Bethesda, MD 20892-7510, or at mk90h{at}nih.gov.

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