Seprafilm® Adhesion Barrier and Cesarean Delivery

Phase 4

Completed

Conditions: Delivery, Obstetric
Adhesions
Cesarean Section

Interventions: Device: Placebo
Device: modified sodium hyaluronic acid and carboxymethylcellulose

Registration Number: NCT00565643

Lead Sponsor: Winthrop University Hospital

Brief 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).

Detailed Description: Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.

If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:

1. Group A - Placement of Seprafilm® prior to abdominal closure

2. Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement.

The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.

The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.

A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications.

If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. The investigators will extract additional data from the chart including operative times, blood loss, and complications. An evaluation of adhesions would conclude the patient's participation in the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 753

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Closure Group	Placebo	Routine Closure without placement of an adhesion barrier
HA-CMC Group	modified sodium hyaluronic acid and carboxymethylcellulose	Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Post-operative Hemoglobin	1 to 5 years	Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
Post-operative White Blood Cell Count	1 to 5 years	Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
Post-Operative Complications	1 to 5 years	Percentage of patients experiencing any of the predefined post-operative complications following randomization
Post-operative Maximum Temperature Following Randomization	1 to 5 years	Maximum temperature of patient, \>24 hours following randomization delivery
Operative Times at Subsequent Delivery	3 to 5 years	Amount of time spent at the time of the subsequent delivery

Trial Locations

Locations (3): 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