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

Status unconfirmed

Conditions studied: Pre-term Birth

In brief

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.

Key facts

Study ID

NCT01955148

Run by

Hologic, Inc.

People needed

1210

Starts

2013-10-01

Expected to finish

2016-09-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation
• Maternal age ≥18 years of age
• Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study
• 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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