Abstract | OBJECTIVE: 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: 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:
|
Authors | H M McDonald, J A O'Loughlin, R Vigneswaran, P T Jolley, J A Harvey, A Bof, P J McDonald |
Journal | British journal of obstetrics and gynaecology
(Br J Obstet Gynaecol)
Vol. 104
Issue 12
Pg. 1391-7
(Dec 1997)
ISSN: 0306-5456 [Print] England |
PMID | 9422018
(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)
|