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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:October 2013
End Date:September 2016
Contact:Christina M Mastandrea
Email:christina.mastandrea@hologic.com
Phone:5082638772

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

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.

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.

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
We found this trial at
16
sites
Pittsburgh, Pennsylvania 15213
Principal Investigator: Hyagriv Simhan, MD
Phone: 412-641-4874
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Errol Norwitz, MD, Ph.D.
Phone: 617-636-2382
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Kathryn Menard, MD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
Principal Investigator: Allen Rappleye, MD
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Albuquerque, New Mexico 87106
Principal Investigator: Michael S Ruma, , BS, MPH
Phone: 505-764-9535
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Birmingham, Alabama 35294
Principal Investigator: Joseph Biggio, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37403
Principal Investigator: David Adair, MD
Phone: 423-826-8086
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Columbus, Ohio 43210
Principal Investigator: Catalin Buhimschi, MD
Phone: 614-293-8949
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Galveston, Texas
Principal Investigator: George Saade, MD
Phone: 409-772-0312
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Houston, Texas 77030
Principal Investigator: Sean Blackwell, MD
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Lawrenceville, New Jersey 08648
Principal Investigator: Kira Pryzbylko, MD
Phone: 609-803-2378
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Newark, Delaware 19718
Principal Investigator: Anthony Sciscione, DO
Phone: 302-733-3576
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Oklahoma, Oklahoma 73190
Principal Investigator: Eric Knudtson, MD
Phone: 405-271-8001
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San Diego, California 92123
Principal Investigator: Rovena Reagan, MD
Phone: 858-505-8672
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Principal Investigator: Glenn Markenson, MD
Phone: 413-794-3118
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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