Clinical trial NCT01955148: fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth
Official title: Prospective Phase III Evaluation Of Fetal Fibronectin In A High Risk Asymptomatic Population For The Prediction Of Spontaneous Preterm Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-term Birth
Keywords: PTB
sPTB
cervical cerclage
LEEP
PROM
short cervix
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 1210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with a high and low level of fFN as a Measure of Predicting Pre-Term Birth
timeFrame: 18 months
Secondary outcomes:
measure: Number of Participants with a moderate level of fFN as a Measure of Predicting Pre-Term Birth
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: Women's Health Care Research Corp.
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Perinatal Associates of New Mexico
state: New Mexico
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh - Magee Women's Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
city: Galveston
country: United States
facility: University of Texas - Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: UTHealth - Medical School at Houston
name: Sean C Blackwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Errol Norwitz, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Joseph Biggio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Obstetrics Consultants, PC
name: David Adair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services, Inc.
name: Anthony Sciscione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Eugene Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Board of Regents of the University of Oklahoma
name: Eric Knudtson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Kathryn Menard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Medical Branch at Galveston
name: George Saade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Catalin Buhimschi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lawrence OB/GYN Associates
name: Kira Pryzbylko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baystate Medical Center
name: Glenn Markenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh - Magee Women's Hospital
name: Hyagriv Simhan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Perinatal Associates of New Mexico
name: Michael S Ruma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Brown Research
name: Allen Rappleye, MD
role: PRINCIPAL_INVESTIGATOR
References: