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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hologic, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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