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COMPLETED Phase 4

Seprafilm® Adhesion Barrier and Cesarean Delivery

NCT00565643 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 753 participants
Start Date 2007-11
Est. Completion 2014-10
Phase Phase 4

Sponsor

Winthrop University Hospital

6 total trials

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 753 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winthrop University Hospital, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00565643 reports 3 study locations spanning 2 distinct geographic areas — top geographies include New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00565643?

The interventions under investigation include: Placebo (DEVICE), modified sodium hyaluronic acid and carboxymethylcellulose (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00565643?

This trial is sponsored by Winthrop University Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial