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

NCT01955148 | Unknown

• 1 other identifier: 10Q01
• Study Type: observational
• Target: 1,210
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Pre-term Birth

Keywords

PTB; sPTB; cervical cerclage; LEEP; PROM; short cervix

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth

  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 Outcomes (1)

• Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth

  18 months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation
• Maternal age ≥18 years of age
• Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study
• 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

You may not qualify if:

• Maternal age under 18
• Suspected or proven rupture of fetal membranes at the time of specimen collection
• Known significant congenital structural or chromosomal fetal anomaly
• Women with moderate or gross bleeding evident on speculum examination
• Women who have had sexual intercourse within 24 hours prior to specimen collection
• Cervical cerclage at time of specimen collection
• Current triplet (or more) pregnancy
• Placenta previa with active bleeding

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (16)

University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Women's Health Care Research Corp.

San Diego, California, 92123, United States

RECRUITING

Christiana Hospital

Newark, Delaware, 19713, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

NOT YET RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Lawrence OB/GYN Associates

Lawrenceville, New Jersey, 08648, United States

RECRUITING

Perinatal Associates of New Mexico

Albuquerque, New Mexico, 87106, United States

RECRUITING

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

University of Pittsburgh - Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

ACTIVE NOT RECRUITING

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403-2724, United States

RECRUITING

University of Texas - Medical Branch at Galveston

Galveston, Texas, 77555, United States

RECRUITING

University of Texas-Houston

Houston, Texas, 77030, United States

RECRUITING

Jean Brown Research

Salt Lake City, Utah, 84124, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

cervicovaginal fluid

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina M Mastandrea

CONTACT

5082638772; christina.mastandrea@hologic.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (16)