Seprafilm® Adhesion Barrier and Cesarean Delivery

Study Overview
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Brief Summary
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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
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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: Group A - Placement of Seprafilm® prior to abdominal closure 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.

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

Conditions
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Adhesions, Cesarean Section, Delivery, Obstetric

Intervention / Treatment
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* Device: modified sodium hyaluronic acid and carboxymethylcellulose
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA-CMC Group<br>Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier | Device: modified sodium hyaluronic acid and carboxymethylcellulose<br>* Adhesion barrier applied at the time of initial cesarean delivery<br>* Other names: Seprafilm Adhesion Barrier;|
| Placebo Comparator: Routine Closure Group<br>Routine Closure without placement of an adhesion barrier | Device: Placebo<br>* Routine abdominal closure without placement of adhesion barrier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adhesions | The Percentage of participants with one or more adhesions, regardless of the extent or severity | 3 to 5 years | 
| Adhesion Score | 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). | 3 to 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesion, Seprafilm, Cesarean section