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

August 24, 2015 updated by: Hologic, Inc.

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama
        • Principal Investigator:
          • Joseph Biggio, MD
        • Contact:
        • Contact:
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Women's Health Care Research Corp.
        • Principal Investigator:
          • Rovena Reagan, MD
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Hospital
        • Contact:
        • Principal Investigator:
          • Anthony Sciscione, DO
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Not yet recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Errol Norwitz, MD, Ph.D.
      • Springfield, Massachusetts, United States, 01199
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Recruiting
        • Lawrence OB/GYN Associates
        • Contact:
        • Principal Investigator:
          • Kira Pryzbylko, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • Perinatal Associates of New Mexico
        • Contact:
        • Principal Investigator:
          • Michael S Ruma,, BS, MPH
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • The University of North Carolina at Chapel Hill
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathryn Menard, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Contact:
        • Principal Investigator:
          • Catalin Buhimschi, MD
    • Oklahoma
      • Oklahoma, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Principal Investigator:
          • Eric Knudtson, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh - Magee Women's Hospital
        • Principal Investigator:
          • Hyagriv Simhan, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Active, not recruiting
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403-2724
        • Recruiting
        • Regional Obstetrical Consultants
        • Contact:
        • Principal Investigator:
          • David Adair, MD
    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas - Medical Branch at Galveston
        • Principal Investigator:
          • George Saade, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas-Houston
        • Contact:
        • Principal Investigator:
          • Sean Blackwell, MD
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Jean Brown Research
        • Contact:
        • Principal Investigator:
          • Allen Rappleye, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Only subjects who are at high risk for preterm birth and meet the inclusion criteria will be included in this study. Subjects may be recruited from each clinical site's routine or referral population. Pregnant women who meet the study eligibility criteria will be screened for possible inclusion in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
Short cervical length
Short cervical length (≤25 mm) determined by transvaginal ultrasound
Twin Pregnancy
Current twin pregnancy
Prior cervicdal surgeries
Cervical cerclage in a prior pregnancy or prior cone biopsy or prior LEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth
Time Frame: 18 months
To determine whether the rate of spontaneous delivery < 35 weeks in women with a high level of fFN (equivalent to ≥ 200 ng/mL) is greater than in women with a low fFN (< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk coho
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth
Time Frame: 18 months
To determine whether the rate of spontaneous delivery < 35 weeks in women with a moderate level of fFN (10-199 ng/mL) is greater than in women with a low fFN (< 10 ng/mL) measured from 16 weeks, 0 days to 21 weeks, 6 days' gestation in a high risk cohort.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Investigators

  • Principal Investigator: Sean C Blackwell, MD, UTHealth - Medical School at Houston
  • Principal Investigator: Errol Norwitz, MD, Ph.D., Tufts Medical Center
  • Principal Investigator: Joseph Biggio, MD, University of Alabama at Birmingham
  • Principal Investigator: David Adair, MD, Regional Obstetrics Consultants, PC
  • Principal Investigator: Anthony Sciscione, MD, Christiana Care Health Services, Inc.
  • Principal Investigator: Eugene Chang, MD, Medical University of South Carolina
  • Principal Investigator: Eric Knudtson, MD, Board of Regents of the University of Oklahoma
  • Principal Investigator: Kathryn Menard, MD, University of North Carolina, Chapel Hill
  • Principal Investigator: George Saade, MD, The University of Texas Medical Branch at Galveston
  • Principal Investigator: Catalin Buhimschi, MD, Ohio State University
  • Principal Investigator: Kira Pryzbylko, MD, Lawrence OB/GYN Associates
  • Principal Investigator: Glenn Markenson, MD, Baystate Medical Center
  • Principal Investigator: Hyagriv Simhan, MD, University of Pittsburgh - Magee Women's Hospital
  • Principal Investigator: Michael S Ruma, MD, Perinatal Associates of New Mexico
  • Principal Investigator: Allen Rappleye, MD, Jean Brown Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10Q01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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