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

• Conditions: Pre-term Birth

• Registration Number: NCT01955148
• Lead Sponsor: Hologic, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-09-24
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26
• Primary Completion: 2016-07
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth	18 months	To determine whether the rate of spontaneous delivery \< 35 weeks in women with a high level of fFN (equivalent to ≥ 200 ng/mL) is greater than in women with a low fFN (\< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk coho

Secondary Outcome Measures

Name	Time	Method
Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth	18 months	To determine whether the rate of spontaneous delivery \< 35 weeks in women with a moderate level of fFN (10-199 ng/mL) is greater than in women with a low fFN (\< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk cohort.

Trial Locations

Locations (16)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Lawrence OB/GYN Associates; 🇺🇸 Lawrenceville, New Jersey, United States

Perinatal Associates of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of Oklahoma; 🇺🇸 Oklahoma, Oklahoma, United States

University of Texas-Houston; 🇺🇸 Houston, Texas, United States

Women's Health Care Research Corp.; 🇺🇸 San Diego, California, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

University of Pittsburgh - Magee Women's Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Regional Obstetrical Consultants; 🇺🇸 Chattanooga, Tennessee, United States

University of Texas - Medical Branch at Galveston; 🇺🇸 Galveston, Texas, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States