National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

Randomized Clinical Trial of Metronidazole on Pregnancy Outcome
in Women Infected with T. Vaginalis or Bacterial Vaginosis

Related Publications & Presentations

Objective

To establish whether metronidazole therapy will reduce the risk of preterm delivery in women who have asymptomatic T. vaginalis or bacterial vaginosis.

Conclusion

BV Trial - Although effective at eliminating BV, treatment of asymptomatic BV with metronidazole did not prevent PTD or other adverse outcomes.

TV Trial - In asymptomatic women with TV, metronidazole treatment increased the risk of preterm birth. Routine screening and treatment of asymptomatic women with TV cannot be recommended.

Clinical Centers

Magee Womens, Tennessee, Southern California, Alabama, Wayne State, Cincinnati, Oklahoma, Bowman Gray, Chicago, Ohio State, MUSC, UT San Antonio, UT Dallas, Utah, Miami, Thomas Jefferson

Major Eligibility Criteria

• For BV trial:
• Gram stain positive
• TV culture negative
• For TV trial:
• TV culture positive
• Less than 24 weeks gestation
• Informed consent

Groups

• Experimental:
• Four doses of 2 g metronidazole
• Placebo:
• Four doses of matching placebo

Sample Size

• Goal = 3800
• BV trial: 1900 (950/group)
• TV trial: 1900 (950/group)

Management Protocols

• Coded medication: Four 2 gram doses:
• Dose 1 - Randomization
• Dose 2 - 48 hours after dose 1
• Dose 3 - Follow-up visit
• Dose 4 - 48 hours after dose 3

Outcome Measures

• Primary:
• Preterm delivery (< 37 weeks gestation)
• Secondary:
• Low birthweight (< 2,500 grams)
• Adverse effects of metronidazole
• Preterm PROM
• Intra-amniotic infection
• Postpartum endometritis

Timetable

• Randomization:
• BV trial: 05/95-03/97
• TV trial: 05/95-07/99
• Data Collection:
• BV trial: 05/95-09/97
• TV trial: 05/95-01/00

Closeout/Final Analysis:

• BV trial: 09/97-05/98
• TV trial: 01/00-09/00