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Impact of metronidazole therapy on preterm birth in women with bacterial vaginosis flora (Gardnerella vaginalis): a randomised, placebo controlled trial.

AbstractOBJECTIVE:
To ascertain whether metronidazole treatment of women with a heavy growth of Gardnerella vaginalis during mid-pregnancy would reduce the risk of spontaneous preterm birth.
DESIGN:
A multicentre, randomised, placebo-controlled trial.
SETTING:
Four metropolitan hospitals.
PARTICIPANTS:
Eight hundred and seventy-nine singleton women with a heavy growth of G. vaginalis or Gram stain indicative of bacterial vaginosis at 19 weeks of gestation.
INTERVENTIONS:
Oral metronidazole (400 mg) or placebo twice daily for two days at 24 weeks of gestation, and at 29 weeks if G. vaginalis found in test-of-cure swab four weeks after treatment.
MAIN OUTCOME MEASURES:
Spontaneous preterm birth less than 37 weeks.
RESULTS:
Intention-to-treat analysis showed no difference between metronidazole and placebo groups in overall preterm birth (31/429 [7.2%] vs 32/428 [7.5%]) or spontaneous preterm birth (20/429 [4.7%] vs 24/428 [5.6%]). Among the 480 women with bacterial vaginosis treatment had no effect on spontaneous preterm birth (11/242 [4.5%] vs 15/238 [6.3%]). In the subset of 46 women with a previous preterm birth, women in the metronidazole group showed a significant reduction in spontaneous preterm birth (2/22 [9.1%] vs 10/24 [41.7%], OR 0.14, 95% CI 0.01-0.84). A treatment effect was also found in compliant women with a previous preterm birth and bacterial vaginosis (0/14 [0%] vs 6/17 [35.3%], OR 0.0, 95% CI 0.0-0.94).
CONCLUSION:
Metronidazole treatment of women with a heavy growth of G. vaginalis or bacterial vaginosis did not reduce the preterm birth rate. Among women with a previous preterm birth, treatment reduced the risk of spontaneous preterm birth. Further studies are required to confirm these findings.
AuthorsH M McDonald, J A O'Loughlin, R Vigneswaran, P T Jolley, J A Harvey, A Bof, P J McDonald
JournalBritish journal of obstetrics and gynaecology (Br J Obstet Gynaecol) Vol. 104 Issue 12 Pg. 1391-7 (Dec 1997) ISSN: 0306-5456 [Print] England
PMID9422018 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antitrichomonal Agents
  • Metronidazole
Topics
  • Adult
  • Antitrichomonal Agents (adverse effects, therapeutic use)
  • Female
  • Gardnerella vaginalis
  • Humans
  • Metronidazole (adverse effects, therapeutic use)
  • Obstetric Labor, Premature (microbiology, prevention & control)
  • Pregnancy
  • Risk Factors
  • Treatment Outcome
  • Vaginosis, Bacterial (complications, drug therapy)

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