Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

NCT00883324 | Completed

• 1 other identifier: D0108001
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 5

Brief Summary

Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.

Conditions

Preterm Delivery

Keywords

fFN; fetal fibronectin; non-speculum; risk of preterm delivery

Study Arms (2)

1

fetal fibronectin specimens collected with a speculum

2

fetal fibronectin specimens collected without a speculum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Labor and delivery triage, prenatal clinic

You may qualify if:

• Maternal age \> 18 years.
• Subject has signed and dated an Institutional Review Board (IRB) or Research Ethics Board (REB) approved consent form to participate in the study.
• Specimen Collection Kit and the Rapid fFN for the TLiIQ® System are currently utilized as standard of care (SOC).
• Gestational age of ≥ 24 weeks, 0 days and ≤ 34 weeks, 6 days for symptomatic subjects. (As defined by ACOG.)
• Gestational age of ≥ 22 weeks, 0 days and ≤ 30 weeks, 6 days for asymptomatic subjects with singleton pregnancies. (As defined by ACOG.)
• Intact amniotic membranes.

You may not qualify if:

• Placenta previa or abruptio placenta.
• Cervical cerclage.
• Digital examination, vaginal intercourse, or transvaginal ultrasound within 24 hours prior to the fFN sample collection.
• Moderate or gross vaginal bleeding at the time of fFN sample collection. Cervical dilatation ≥ 3 centimeters.

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (5)

Santa Clara Valley Medical Health & Hospital System

San Jose, California, 95128, United States

Location

Yale University Medical Center

New Haven, Connecticut, 06511, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Kettering Health Network of Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• James D. Byrne, M.D.

  Santa Clara Valley Medical Health & Hospital System

  PRINCIPAL INVESTIGATOR

• Michael Paidas, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Larry Matsumoto, M.D.

  Northside Hospital Center for Perinatal Medicine

  PRINCIPAL INVESTIGATOR

• Janice Whitty, MD

  Meharry Medical College

  PRINCIPAL INVESTIGATOR

• John Allbert, MD

  Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Annette E. Bombrys, DO

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 17, 2009
• Study Start: March 1, 2009
• Last Updated: June 20, 2011

Record last verified: 2011-06

Locations

US (5)