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

ClinicalTrials.gov ID: NCT01955148

Public ClinicalTrials.gov record NCT01955148. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01955148
Recruitment status: Not listed
Study type: Observational
Phase: Not listed
Lead sponsor: Hologic, Inc.; Industry
Enrollment: 1,210 participants

Conditions and interventions

Conditions

Pre-term Birth

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 30, 2013
Primary completion: Jun 30, 2016
Completion: Aug 31, 2016
Last update posted: Aug 25, 2015

2013 – 2016

United States locations

U.S. sites: 16
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
University of Alabama	Birmingham	Alabama	35233	Recruiting
Women's Health Care Research Corp.	San Diego	California	92123	Recruiting
Christiana Hospital	Newark	Delaware	19713	Recruiting
Tufts Medical Center	Boston	Massachusetts	02111	Not yet recruiting
Baystate Medical Center	Springfield	Massachusetts	01199	Recruiting
Lawrence OB/GYN Associates	Lawrenceville	New Jersey	08648	Recruiting
Perinatal Associates of New Mexico	Albuquerque	New Mexico	87106	Recruiting
The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27514	Recruiting
Ohio State University Medical Center	Columbus	Ohio	43210	Recruiting
University of Oklahoma	Oklahoma City	Oklahoma	73104	Recruiting
University of Pittsburgh - Magee Women's Hospital	Pittsburgh	Pennsylvania	15213	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29425	Active, not recruiting
Regional Obstetrical Consultants	Chattanooga	Tennessee	37403-2724	Recruiting
University of Texas - Medical Branch at Galveston	Galveston	Texas	77555	Recruiting
University of Texas-Houston	Houston	Texas	77030	Recruiting
Jean Brown Research	Salt Lake City	Utah	84124	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01955148, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 25, 2015 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01955148 live on ClinicalTrials.gov.

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