Seprafilm® Adhesion Barrier and Cesarean Delivery

Completed · Phase 4 · Has a placebo group

Conditions studied: Adhesions, Cesarean Section, Delivery, Obstetric

In brief

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).

Key facts

Study ID

NCT00565643

Run by

Winthrop University Hospital

People needed

753

Starts

2007-11-01

Expected to finish

2014-10-01

Last updated by the study team

2024-05-14

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women who are planning or have the potential to undergo cesarean delivery
• Age over 18
• Able to consent to study

You may not qualify if…

• Planned tubal ligation
• Known allergy to hyaluronic acid
• Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol

Where it is running

• Winthrop University Hospital — Mineola, New York, United States
• SUNY Stony Brook University Hospital — Stony Brook, New York, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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