MedTrace Logo

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

NCT00883324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 329

Last updated 2011-06-20

No results posted yet for this study

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

Sponsors & Collaborators

  • Hologic, Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Byrne, M.D. · Santa Clara Valley Medical Health & Hospital System

  • Michael Paidas, M.D. · Yale University

  • Larry Matsumoto, M.D. · Northside Hospital Center for Perinatal Medicine

  • Janice Whitty, MD · Meharry Medical College

  • John Allbert, MD · Presbyterian Hospital

  • Annette E. Bombrys, DO · Kettering Health Network

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883324 on ClinicalTrials.gov