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

Prospective Randomized Clinical Trial of Metronidazole
Plus Erythromycin to Prevent Preterm Birth in Women
with Elevated Cervical Oncofetal Fibronectin (FFN)

Related Publications & Presentations

Objective

To test the hypothesis that metronidazole plus erythromycin treatment before 25 weeks reduces the risk of spontaneous preterm delivery in women with elevated oncofetal fibronectin in cervical/vaginal secretions obtained at 21-25 weeks gestation.

Conclusion

Treatment with metronidazole plus erythromycin of asymptomatic women with a positive cervical/vaginal fetal fibronextin test between 21 ⁷ and 25 ⁶ weeks gestational age does not decrease the risk of spontaneous preterm delivery.

Clinical Centers

Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Bowman Gray, Chicago, Ohio State, U of Miami, Texas-Dallas, Texas-San Antonio, Utah, Thomas Jefferson

Major Eligibility Criteria

• Elevated ( 50 ng/ml) oncofetal fibronectin
• Less than 25⁶ weeks gestation

Groups

• Experimental:
• 250 mg metronidazole TID/10 days
• 250 mg erythromycin QID/10 days
• Placebo:
• Matching doses of placebo for erythromycin and metronidazole

Sample Size

• Goal = 700 (350/group)

Management Protocols

• Coded medications:
• 250 mg metronidazole TID/10 days
• 250 mg erythromycin QID/10 days

Outcome Measures

• Primary:
• Spontaneous preterm delivery (37 weeks gestation)
• Secondary:
• Low birthweight (< 2,500 grams)
• Neonatal mortality and morbidity
• Clinical chorioamnionitis
• Early postpartum endometritis

Timetable

• Randomization: 06/96-06/98
• Data Collection: 06/96-12/98
• Closeout/Final Analysis: 12/98-08/99