Preterm Delivery Clinical Trial
— SpecOpOfficial title:
A Phase IIIB Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
NCT number | NCT00883324 |
Other study ID # | D0108001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | April 10, 2009 |
Last updated | June 16, 2011 |
Start date | March 2009 |
Verified date | June 2011 |
Source | Hologic, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 329 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
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 | Yale University Medical Center | New Haven | Connecticut |
United States | Santa Clara Valley Medical Health & Hospital System | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Hologic, Inc. |
United States,
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