fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth

Prospective Phase III Evaluation Of Fetal Fibronectin In A High Risk Asymptomatic Population For The Prediction Of Spontaneous Preterm Birth

This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective observational multi-center study with approximately 15 to 20 US sites, and approximately 1210 subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0 days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be determined based on the date of delivery and the estimated date of confinement (EDC), which will be evaluated in a standardized manner.

Hologic has developed a quantitative test to assess the amount of fetal fibronectin (fFN) present in cervicovaginal secretions, and evaluate the clinical utility of the test in assessing spontaneous Pre-Term Bith risk in a high risk population. Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy. The goal of this study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.

Inclusion Criteria:

1. Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation

2. Maternal age ≥18 years of age

3. Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study

4. Subjects for this study must be at high risk for preterm birth as indicated by at least one of the following:

   • A previous delivery of a live born singleton between 20 weeks, 0 days and 36 weeks, 6 days due to spontaneous preterm premature labor or preterm rupture of fetal membranes
   • Short cervical length (≤25 mm) determined by transvaginal ultrasound
   • Current twin pregnancy
   • Cervical cerclage in a prior pregnancy
   • Prior cone biopsy
   • Prior LEEP / LLETZ

Exclusion Criteria:

1. Maternal age under 18
2. Suspected or proven rupture of fetal membranes at the time of specimen collection
3. Known significant congenital structural or chromosomal fetal anomaly
4. Women with moderate or gross bleeding evident on speculum examination
5. Women who have had sexual intercourse within 24 hours prior to specimen collection
6. Cervical cerclage at time of specimen collection
7. Current triplet (or more) pregnancy
8. Placenta previa with active bleeding