Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection

M. A. Klebanoff, J. C. Carey, J. C. Hauth, S. L. Hillier, R. P. Nugent, E. A. Thom, J. M. Ernest, R. P. Heine, R. J. Wapner, W. Trout, A. Moawad, K. J. Leveno, R. L. Copper, A. Northen, W. W. Andrews, P. Jones, M. D. Lindheimer, N. Elder, T. A. Siddiqi, C. MacPhersonS. Leindecker, M. L. Fischer, S. N. Caritis, M. Cotroneo, T. Camon, S. Beydoun, C. Alfonso, F. Doyle, C. Catz, S. J. Yaffe, J. D. Iams, F. Johnson, M. B. Landon, G. Thurnau, A. Meier, B. A. Collins, F. LeBoeuf, R. B. Newman, B. M. Mercer, R. Ramsey, M. Berkus, S. Nicholson, M. L. Sherman, S. Bloom, M. DiVito, J. Tolosa, D. Dudley, L. Reynolds, P. Meis, E. Mueller-Heubach, M. Swain, S. F. Bottoms, G. S. Norman

Research output: Contribution to journalArticle

312 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)487-493
Number of pages7
JournalNew England Journal of Medicine
Volume345
Issue number7
DOIs
StatePublished - Aug 16 2001
Externally publishedYes

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Trichomonas Infections
Trichomonas vaginalis
Metronidazole
Pregnant Women
Placebos
Pregnancy
Confidence Intervals
Premature Obstetric Labor
Random Allocation
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Klebanoff, M. A., Carey, J. C., Hauth, J. C., Hillier, S. L., Nugent, R. P., Thom, E. A., ... Norman, G. S. (2001). Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection. New England Journal of Medicine, 345(7), 487-493. https://doi.org/10.1056/NEJMoa003329

Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection. / Klebanoff, M. A.; Carey, J. C.; Hauth, J. C.; Hillier, S. L.; Nugent, R. P.; Thom, E. A.; Ernest, J. M.; Heine, R. P.; Wapner, R. J.; Trout, W.; Moawad, A.; Leveno, K. J.; Copper, R. L.; Northen, A.; Andrews, W. W.; Jones, P.; Lindheimer, M. D.; Elder, N.; Siddiqi, T. A.; MacPherson, C.; Leindecker, S.; Fischer, M. L.; Caritis, S. N.; Cotroneo, M.; Camon, T.; Beydoun, S.; Alfonso, C.; Doyle, F.; Catz, C.; Yaffe, S. J.; Iams, J. D.; Johnson, F.; Landon, M. B.; Thurnau, G.; Meier, A.; Collins, B. A.; LeBoeuf, F.; Newman, R. B.; Mercer, B. M.; Ramsey, R.; Berkus, M.; Nicholson, S.; Sherman, M. L.; Bloom, S.; DiVito, M.; Tolosa, J.; Dudley, D.; Reynolds, L.; Meis, P.; Mueller-Heubach, E.; Swain, M.; Bottoms, S. F.; Norman, G. S.

In: New England Journal of Medicine, Vol. 345, No. 7, 16.08.2001, p. 487-493.

Research output: Contribution to journalArticle

Klebanoff, MA, Carey, JC, Hauth, JC, Hillier, SL, Nugent, RP, Thom, EA, Ernest, JM, Heine, RP, Wapner, RJ, Trout, W, Moawad, A, Leveno, KJ, Copper, RL, Northen, A, Andrews, WW, Jones, P, Lindheimer, MD, Elder, N, Siddiqi, TA, MacPherson, C, Leindecker, S, Fischer, ML, Caritis, SN, Cotroneo, M, Camon, T, Beydoun, S, Alfonso, C, Doyle, F, Catz, C, Yaffe, SJ, Iams, JD, Johnson, F, Landon, MB, Thurnau, G, Meier, A, Collins, BA, LeBoeuf, F, Newman, RB, Mercer, BM, Ramsey, R, Berkus, M, Nicholson, S, Sherman, ML, Bloom, S, DiVito, M, Tolosa, J, Dudley, D, Reynolds, L, Meis, P, Mueller-Heubach, E, Swain, M, Bottoms, SF & Norman, GS 2001, 'Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection', New England Journal of Medicine, vol. 345, no. 7, pp. 487-493. https://doi.org/10.1056/NEJMoa003329
Klebanoff, M. A. ; Carey, J. C. ; Hauth, J. C. ; Hillier, S. L. ; Nugent, R. P. ; Thom, E. A. ; Ernest, J. M. ; Heine, R. P. ; Wapner, R. J. ; Trout, W. ; Moawad, A. ; Leveno, K. J. ; Copper, R. L. ; Northen, A. ; Andrews, W. W. ; Jones, P. ; Lindheimer, M. D. ; Elder, N. ; Siddiqi, T. A. ; MacPherson, C. ; Leindecker, S. ; Fischer, M. L. ; Caritis, S. N. ; Cotroneo, M. ; Camon, T. ; Beydoun, S. ; Alfonso, C. ; Doyle, F. ; Catz, C. ; Yaffe, S. J. ; Iams, J. D. ; Johnson, F. ; Landon, M. B. ; Thurnau, G. ; Meier, A. ; Collins, B. A. ; LeBoeuf, F. ; Newman, R. B. ; Mercer, B. M. ; Ramsey, R. ; Berkus, M. ; Nicholson, S. ; Sherman, M. L. ; Bloom, S. ; DiVito, M. ; Tolosa, J. ; Dudley, D. ; Reynolds, L. ; Meis, P. ; Mueller-Heubach, E. ; Swain, M. ; Bottoms, S. F. ; Norman, G. S. / Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection. In: New England Journal of Medicine. 2001 ; Vol. 345, No. 7. pp. 487-493.
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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.",
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TY - JOUR

T1 - Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection

AU - Klebanoff, M. A.

AU - Carey, J. C.

AU - Hauth, J. C.

AU - Hillier, S. L.

AU - Nugent, R. P.

AU - Thom, E. A.

AU - Ernest, J. M.

AU - Heine, R. P.

AU - Wapner, R. J.

AU - Trout, W.

AU - Moawad, A.

AU - Leveno, K. J.

AU - Copper, R. L.

AU - Northen, A.

AU - Andrews, W. W.

AU - Jones, P.

AU - Lindheimer, M. D.

AU - Elder, N.

AU - Siddiqi, T. A.

AU - MacPherson, C.

AU - Leindecker, S.

AU - Fischer, M. L.

AU - Caritis, S. N.

AU - Cotroneo, M.

AU - Camon, T.

AU - Beydoun, S.

AU - Alfonso, C.

AU - Doyle, F.

AU - Catz, C.

AU - Yaffe, S. J.

AU - Iams, J. D.

AU - Johnson, F.

AU - Landon, M. B.

AU - Thurnau, G.

AU - Meier, A.

AU - Collins, B. A.

AU - LeBoeuf, F.

AU - Newman, R. B.

AU - Mercer, B. M.

AU - Ramsey, R.

AU - Berkus, M.

AU - Nicholson, S.

AU - Sherman, M. L.

AU - Bloom, S.

AU - DiVito, M.

AU - Tolosa, J.

AU - Dudley, D.

AU - Reynolds, L.

AU - Meis, P.

AU - Mueller-Heubach, E.

AU - Swain, M.

AU - Bottoms, S. F.

AU - Norman, G. S.

PY - 2001/8/16

Y1 - 2001/8/16

N2 - 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.

AB - 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.

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DO - 10.1056/NEJMoa003329

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