At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
In Brief
A Phase 4 clinical trial evaluating modified sodium hyaluronic acid and carboxymethylcellulose and Placebo for Adhesions and 2 related conditions. Completed, enrolled 753 participants across 3 sites.
Detailed 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).
Study Details
Timeline
Interventions
Adhesion barrier applied at the time of initial cesarean delivery
Routine abdominal closure without placement of adhesion barrier