Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis

J. Christopher Carey, Mark A. Klebanoff, John C. Hauth, Sharon L. Hillier, Elizabeth A. Thom, J. M. Ernest, R. Phillip Heine, Robert P. Nugent, Molly L. Fischer, Kenneth J. Leveno, Ronald Wapner, Michael Varner, Wayne Trout, Atef Moawad, Baha M. Sibai, Menachem Miodovnik, Mitchell Dombrowski, Mary J. O'Sullivan, J. Peter VanDorsten, Oded LangerJames Roberts

Research output: Contribution to journalArticle

486 Citations (Scopus)

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. (C)2000, Massachusetts Medical Society.

Original languageEnglish (US)
Pages (from-to)534-540
Number of pages7
JournalNew England Journal of Medicine
Volume342
Issue number8
DOIs
StatePublished - Feb 24 2000

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Bacterial Vaginosis
Metronidazole
Pregnant Women
Placebos
Staining and Labeling
Therapeutics
Pregnancy
Spontaneous Rupture
Premature Obstetric Labor
Medical Societies
Neonatal Intensive Care Units
Premature Birth
Postpartum Period
Clinical Trials
Confidence Intervals
Recurrence
Membranes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Carey, J. C., Klebanoff, M. A., Hauth, J. C., Hillier, S. L., Thom, E. A., Ernest, J. M., ... Roberts, J. (2000). Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. New England Journal of Medicine, 342(8), 534-540. https://doi.org/10.1056/NEJM200002243420802

Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. / Carey, J. Christopher; Klebanoff, Mark A.; Hauth, John C.; Hillier, Sharon L.; Thom, Elizabeth A.; Ernest, J. M.; Heine, R. Phillip; Nugent, Robert P.; Fischer, Molly L.; Leveno, Kenneth J.; Wapner, Ronald; Varner, Michael; Trout, Wayne; Moawad, Atef; Sibai, Baha M.; Miodovnik, Menachem; Dombrowski, Mitchell; O'Sullivan, Mary J.; VanDorsten, J. Peter; Langer, Oded; Roberts, James.

In: New England Journal of Medicine, Vol. 342, No. 8, 24.02.2000, p. 534-540.

Research output: Contribution to journalArticle

Carey, JC, Klebanoff, MA, Hauth, JC, Hillier, SL, Thom, EA, Ernest, JM, Heine, RP, Nugent, RP, Fischer, ML, Leveno, KJ, Wapner, R, Varner, M, Trout, W, Moawad, A, Sibai, BM, Miodovnik, M, Dombrowski, M, O'Sullivan, MJ, VanDorsten, JP, Langer, O & Roberts, J 2000, 'Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis', New England Journal of Medicine, vol. 342, no. 8, pp. 534-540. https://doi.org/10.1056/NEJM200002243420802
Carey, J. Christopher ; Klebanoff, Mark A. ; Hauth, John C. ; Hillier, Sharon L. ; Thom, Elizabeth A. ; Ernest, J. M. ; Heine, R. Phillip ; Nugent, Robert P. ; Fischer, Molly L. ; Leveno, Kenneth J. ; Wapner, Ronald ; Varner, Michael ; Trout, Wayne ; Moawad, Atef ; Sibai, Baha M. ; Miodovnik, Menachem ; Dombrowski, Mitchell ; O'Sullivan, Mary J. ; VanDorsten, J. Peter ; Langer, Oded ; Roberts, James. / Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. In: New England Journal of Medicine. 2000 ; Vol. 342, No. 8. pp. 534-540.
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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. (C)2000, Massachusetts Medical Society.",
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T1 - Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis

AU - Carey, J. Christopher

AU - Klebanoff, Mark A.

AU - Hauth, John C.

AU - Hillier, Sharon L.

AU - Thom, Elizabeth A.

AU - Ernest, J. M.

AU - Heine, R. Phillip

AU - Nugent, Robert P.

AU - Fischer, Molly L.

AU - Leveno, Kenneth J.

AU - Wapner, Ronald

AU - Varner, Michael

AU - Trout, Wayne

AU - Moawad, Atef

AU - Sibai, Baha M.

AU - Miodovnik, Menachem

AU - Dombrowski, Mitchell

AU - O'Sullivan, Mary J.

AU - VanDorsten, J. Peter

AU - Langer, Oded

AU - Roberts, James

PY - 2000/2/24

Y1 - 2000/2/24

N2 - 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. (C)2000, Massachusetts Medical Society.

AB - 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. (C)2000, Massachusetts Medical Society.

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