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

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.

Conditions

• Pre-term Birth

Sponsors & Collaborators

• Hologic, Inc.

  lead INDUSTRY

Principal Investigators

• Sean C Blackwell, MD · UTHealth - Medical School at Houston

• Errol Norwitz, MD, Ph.D. · Tufts Medical Center

• Joseph Biggio, MD · University of Alabama at Birmingham

• David Adair, MD · Regional Obstetrics Consultants, PC

• Anthony Sciscione, MD · Christiana Care Health Services, Inc.

• Eugene Chang, MD · Medical University of South Carolina

• Eric Knudtson, MD · Board of Regents of the University of Oklahoma

• Kathryn Menard, MD · University of North Carolina, Chapel Hill

• George Saade, MD · The University of Texas Medical Branch at Galveston

• Catalin Buhimschi, MD · Ohio State University

• Kira Pryzbylko, MD · Lawrence OB/GYN Associates

• Glenn Markenson, MD · Baystate Medical Center

• Hyagriv Simhan, MD · University of Pittsburgh - Magee Women's Hospital

• Michael S Ruma, MD · Perinatal Associates of New Mexico

• Allen Rappleye, MD · Jean Brown Research

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-07-31

Completion

2016-09-30

Countries

• United States

Study Locations