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fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth
Salt Lake City, UT
N/A
Waitlist Available
Led By Sean C Blackwell, MD
Research Sponsored by Hologic, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
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.
See full description
Eligible Conditions
- Premature Birth
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth
Secondary study objectives
Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Closest Location:Jean Brown Research· Salt Lake City, UT
Who is running the clinical trial?
Hologic, Inc.Lead Sponsor
47 Previous Clinical Trials
58,693 Total Patients Enrolled
3 Trials studying Premature Birth
918 Patients Enrolled for Premature Birth
Sean C Blackwell, MDPrincipal InvestigatorUTHealth - Medical School at Houston
Errol Norwitz, MD, Ph.D.Principal InvestigatorTufts Medical Center
Joseph Biggio, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
437 Total Patients Enrolled
Anthony Sciscione, MDPrincipal InvestigatorChristiana Care Health Services, Inc.
Eugene Chang, MDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
46 Total Patients Enrolled
Eric Knudtson, MDPrincipal InvestigatorBoard of Regents of the University of Oklahoma
2 Previous Clinical Trials
7 Total Patients Enrolled
2 Trials studying Premature Birth
7 Patients Enrolled for Premature Birth
Kathryn Menard, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
George Saade, MDPrincipal InvestigatorThe University of Texas Medical Branch at Galveston
4 Previous Clinical Trials
15,837 Total Patients Enrolled
Catalin Buhimschi, MDPrincipal InvestigatorOhio State University