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

Pre-term Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01955148
• Other study ID #: 10Q01
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2013
• Last updated: August 24, 2015
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Hologic, Inc.
• Contact: Christina M Mastandrea
• Phone: 5082638772
• Email: christina.mastandrea[@]hologic.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1210
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-term Birth
• Premature Birth

Locations

Country	Name	City	State
United States	Perinatal Associates of New Mexico	Albuquerque	New Mexico
United States	University of Alabama	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Regional Obstetrical Consultants	Chattanooga	Tennessee
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Texas - Medical Branch at Galveston	Galveston	Texas
United States	University of Texas-Houston	Houston	Texas
United States	Lawrence OB/GYN Associates	Lawrenceville	New Jersey
United States	Christiana Hospital	Newark	Delaware
United States	University of Oklahoma	Oklahoma	Oklahoma
United States	University of Pittsburgh - Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	Jean Brown Research	Salt Lake City	Utah
United States	Women's Health Care Research Corp.	San Diego	California
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth	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	18 months	No
Secondary	Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth	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.	18 months	No