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NCT00565643 · ClinicalTrials.gov registry record · Phase 4
Seprafilm® Adhesion Barrier and Cesarean Delivery
A Phase 4 study of Cesarean Section and Delivery, Obstetric, sponsored by Winthrop University Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 753
- Enrollment target
- 3
- Study locations
NCT00565643 is a Phase 4 study of Cesarean Section and Delivery, Obstetric that has completed, run by Winthrop University Hospital. The registered enrollment target is 753 participants, above the 117-participant average among 14 other Cesarean Section trials with a reported enrollment target (544% higher). The trial reports 3 study locations across 2 states.
The verdict
NCT00565643, a Phase 4 study of Cesarean Section and Delivery, Obstetric, has completed, sponsored by Winthrop University Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 753 participants
- Enrollment target
- 3
- Study locations
Study Summary
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).
Conditions Studied
Interventions
- DEVICE Placebo
- DEVICE modified sodium hyaluronic acid and carboxymethylcellulose
Study Locations (3)
New York
- Winthrop University Hospital - Mineola
- SUNY Stony Brook University Hospital - Stony Brook
Pennsylvania
- Lehigh Valley Hospital - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 753 participants |
| Start Date | 2007-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00565643
The ClinicalTrials.gov registry entry for NCT00565643 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 753 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 117-participant average among 14 other Cesarean Section trials with a reported enrollment target (544% higher). The listed sponsor is Winthrop University Hospital, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cesarean Section appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00565643 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00565643 about?
NCT00565643 is a clinical study titled "Seprafilm® Adhesion Barrier and Cesarean Delivery". A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Sec...
What is the current status of trial NCT00565643?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 753 participants. The study started on 2007-11. Estimated completion is 2014-10.
What conditions does trial NCT00565643 study?
This clinical trial studies the following conditions: Cesarean Section, Delivery, Obstetric, Adhesions.
What interventions are being tested in trial NCT00565643?
The interventions under investigation include: Placebo (DEVICE), modified sodium hyaluronic acid and carboxymethylcellulose (DEVICE).
Who is sponsoring clinical trial NCT00565643?
This trial is sponsored by Winthrop University Hospital, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00565643 being conducted?
This trial has 3 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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