Status:
COMPLETED
Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
Lead Sponsor:
Hologic, Inc.
Conditions:
Preterm Delivery
Eligibility:
FEMALE
18+ years
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 ...
Detailed Description
The study population will include pregnant women who may be at risk for preterm delivery and require the fFN test, as determined by their doctor to aid in patient management. The subjects may or may n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00883324
Start Date
March 1 2009
Last Update
June 20 2011
Active Locations (5)
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1
Santa Clara Valley Medical Health & Hospital System
San Jose, California, United States, 95128
2
Yale University Medical Center
New Haven, Connecticut, United States, 06511
3
Northside Hospital
Atlanta, Georgia, United States, 30342
4
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204