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NCT00883324 · ClinicalTrials.gov registry record
Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
A clinical trial, sponsored by Hologic.
- Completed
- Registry status
- 329
- Enrollment target
NCT00883324: Completed study, sponsored by Hologic.
NCT00883324 is a clinical trial that has completed, run by Hologic. The registered enrollment target is 329 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00883324 has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- 329 participants
- Enrollment target
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2009-03 |
What the finished NCT00883324 record still lists
NCT00883324 is an observational study that tracks outcomes without assigning an intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00883324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00883324 about?
NCT00883324 is a clinical study titled "Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum". 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 ag...
What is the current status of trial NCT00883324?
This trial is currently completed. The enrollment target is 329 participants. The study started on 2009-03.
Who is sponsoring clinical trial NCT00883324?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
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