title: Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection.
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.
authors.affiliation: National Institute of Child Health and Human Development, Bethesda, MD 20892-7510, USA. mk90h@nih.gov
authors.forename: M A
authors.initials: MA
authors.lastname: Klebanoff
authors.forename: J C
authors.initials: JC
authors.lastname: Carey
authors.forename: J C
authors.initials: JC
authors.lastname: Hauth
authors.forename: S L
authors.initials: SL
authors.lastname: Hillier
authors.forename: R P
authors.initials: RP
authors.lastname: Nugent
authors.forename: E A
authors.initials: EA
authors.lastname: Thom
authors.forename: J M
authors.initials: JM
authors.lastname: Ernest
authors.forename: R P
authors.initials: RP
authors.lastname: Heine
authors.forename: R J
authors.initials: RJ
authors.lastname: Wapner
authors.forename: W
authors.initials: W
authors.lastname: Trout
authors.forename: A
authors.initials: A
authors.lastname: Moawad
authors.forename: K J
authors.initials: KJ
authors.lastname: Leveno
authors.forename: M
authors.initials: M
authors.lastname: Miodovnik
authors.forename: B M
authors.initials: BM
authors.lastname: Sibai
authors.forename: J P
authors.initials: JP
authors.lastname: Van Dorsten
authors.forename: M P
authors.initials: MP
authors.lastname: Dombrowski
authors.forename: M J
authors.initials: MJ
authors.lastname: O'Sullivan
authors.forename: M
authors.initials: M
authors.lastname: Varner
authors.forename: O
authors.initials: O
authors.lastname: Langer
authors.forename: D
authors.initials: D
authors.lastname: McNellis
authors.forename: J M
authors.initials: JM
authors.lastname: Roberts
mesh_terms: D000328:Adult; D000818:Animals; D000994:Antitrichomonal Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008795:Metronidazole / Q000627:therapeutic use*; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D011247:Pregnancy; D011248:Pregnancy Complications; D015597:Pregnancy Complications, Parasitic / Q000188:drug therapy*; D017211:Treatment Failure; D014247:Trichomonas Vaginitis / Q000188:drug therapy*; D014246:Trichomonas vaginalis / Q000302:isolation & purification; D014621:Vagina / Q000469:parasitology
chemical_list: D000994:Antitrichomonal Agents; D008795:Metronidazole