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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-term Birth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prior sPTB or PROM

Women who have had 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

No interventions assigned to this group

Short cervical length

Short cervical length (≤25 mm) determined by transvaginal ultrasound

No interventions assigned to this group

Twin Pregnancy

Current twin pregnancy

No interventions assigned to this group

Prior cervicdal surgeries

Cervical cerclage in a prior pregnancy or prior cone biopsy or prior LEEP

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Christina M Mastandrea

Role: CONTACT

[email protected]

5082638772

Facility Contacts

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Pam Files, RN

Role: primary

[email protected]

[email protected]

409-772-0312

Maria Hutchinson

Role: primary

[email protected]

Allison Jones

Role: primary

[email protected]

801-261-2000

Other Identifiers

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10Q01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta

Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

Protein and Ultrasound Indicators of Preterm Birth

Detailed Description

Conditions

Study Design

Study Groups

Prior sPTB or PROM

Short cervical length

Twin Pregnancy

Prior cervicdal surgeries

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hologic, Inc.

Responsible Party

Principal Investigators

Sean C Blackwell, MD

Errol Norwitz, MD, Ph.D.

Joseph Biggio, MD

David Adair, MD

Anthony Sciscione, MD

Eugene Chang, MD

Eric Knudtson, MD

Kathryn Menard, MD

George Saade, MD

Catalin Buhimschi, MD

Kira Pryzbylko, MD

Glenn Markenson, MD

Hyagriv Simhan, MD

Michael S Ruma, MD

Allen Rappleye, MD

Locations

University of Alabama

Women's Health Care Research Corp.

Christiana Hospital

Tufts Medical Center

Baystate Medical Center

Lawrence OB/GYN Associates

Perinatal Associates of New Mexico

The University of North Carolina at Chapel Hill

Ohio State University Medical Center

University of Oklahoma

University of Pittsburgh - Magee Women's Hospital

Medical University of South Carolina

Regional Obstetrical Consultants

University of Texas - Medical Branch at Galveston

University of Texas-Houston

Jean Brown Research

Countries

Central Contacts

Christina M Mastandrea

Facility Contacts

Pam Files, RN

Rachel LeDuke, RN

Angelica Castillo

Stephanie Lynch, RN, BSN

Errol Norwitz, M.D., Ph.D.

Joanne Montgomery

Melissa Witt

Michael S Ruma, MD, BS, MPH

Zoe Frolking

Karen Dorman, RN

Hetty Walker, RNC-OB

Christy Zornes

Meliss Bickus, RN

Lorrie Mason, NP

Ashley Salazar, RN, MSN

Maria Hutchinson

Allison Jones

Other Identifiers

10Q01