Who is sponsoring NCT00565643?

NCT00565643 is sponsored by Winthrop University Hospital.

What condition does NCT00565643 study?

NCT00565643 studies Adhesions, Cesarean Section, Delivery, Obstetric.

What drugs are being tested in NCT00565643?

Interventions: modified sodium hyaluronic acid and carboxymethylcellulose, Placebo.

What is the status of NCT00565643?

NCT00565643 is currently COMPLETED.

Last reviewed 2024-04-22 · How we verify

A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery

NCT00565643 Phase 4 COMPLETED Results posted

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).

Details

Lead sponsor	Winthrop University Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	753
Start date	2007-11
Completion	2014-10

Conditions

Adhesions
Cesarean Section
Delivery, Obstetric

Interventions

modified sodium hyaluronic acid and carboxymethylcellulose
Placebo

Primary outcomes

Incidence of Adhesions — 3 to 5 years
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Adhesion Score — 3 to 5 years
Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).

Countries

United States