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

Fetal Fibronectin Ancillary Study to the Randomized Clinical Trials
of the Effect of Metronidazole on Pregnancy Outcome in Women Infected
with T.Vaginalis and Bacterial Vaginosis (FFN cohort)

Related Publications & Presentations

Objective

To test the hypotheses that: 1) women with elevated cervical FFN prior to 23 weeks gestation are at increased 23 weeks gestation are at increased risk of spontaneous preterm birth prior to 32 weeks, and 2) women who are BV or TV positive with positive FFN will have a reduced chance of spontaneous preterm birth prior to 32 weeks if they aretreated with treated with antibiotics.

Conclusion

Elevated vaginal fetal fibronectin levels from 13 to 22 weeks' gestation are associated with a significantly increased risk of spontaneous preterm birth.

Clinical Centers

Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Oklahoma, BowmanGray, Chicago, Ohio State, UT San Antonio, UT Dallas, Utah, Miami, Thomas Jefferson

Major Eligibility Criteria

All women who have a pelvic screening exam for the BV/TV study

• Sample Size
• Goal = 11,000
• 1,900 randomized to BV trial
• 700 randomized to TV trial
• 8,400 screened patients not eligible for randomization

Scheduled Evaluations/Data Collection

• Non-randomized patients:
• FFN specimen taken at screening
• Race, parity, type of delivery, gestational age, infant birthweight collected at delivery
• Chart review of all patients who deliver before 37 weeks
• Randomized patients:
• FFN specimen taken at screening, randomization and follow-up
• No additional data is needed on patients who participate in the trial

Outcome Measures

• Primary:
• Spontaneous preterm delivery (< 32 weeks)

Timetable

• Randomization: 10/95-03/97
• Data Collection: 10/95-09/97
• Closeout/Final Analysis: 09/97-05/98