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

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