Phase 4
N=753
Seprafilm® Adhesion Barrier and Cesarean Delivery
Adhesions · Cesarean Section · Delivery, Obstetric
Bottom Line
View on ClinicalTrials.gov: NCT00565643 ↗Enrolled (actual)
753
Serious AEs
0.9%
Results posted
Apr 2016
Primary outcome: Primary: Incidence of Adhesions — 75.6; 75.9 percentage of patients with adhesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- modified sodium hyaluronic acid and carboxymethylcellulose (Device); Placebo (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Winthrop University Hospital
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adhesions |
75.6; 75.9 | — |
| PRIMARY Adhesion Score |
2; 2 | — |
| SECONDARY Post-operative Hemoglobin |
29.9; 30.2 | — |
| SECONDARY Post-operative White Blood Cell Count |
11.3; 11.0 | — |
| SECONDARY Post-Operative Complications |
6.3; 4.0; 4.5; 3.0; 0; 0 | — |
| SECONDARY Post-operative Maximum Temperature Following Randomization |
98.2; 98.2 | — |
| SECONDARY Operative Times at Subsequent Delivery |
13; 13; 51; 54 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Pregnant women who are planning or have the potential to undergo cesarean delivery
- Age over 18
- Able to consent to study
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00565643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.