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

Completed

Conditions studied: Preterm Delivery

In brief

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.

Key facts

Study ID

NCT00883324

Run by

Hologic, Inc.

People needed

329

Starts

2009-03-01

Last updated by the study team

2011-06-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Santa Clara Valley Medical Health & Hospital System — San Jose, California, United States
• Yale University Medical Center — New Haven, Connecticut, United States
• Northside Hospital — Atlanta, Georgia, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• Kettering Health Network of Kettering Medical Center — Kettering, Ohio, United States

Full record on ClinicalTrials.gov

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