Seprafilm® Adhesion Barrier and Cesarean Delivery

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

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 Overview

• Status: Completed
• Conditions: Cesarean Section; Adhesions; Delivery, Obstetric
• Intervention / Treatment: Device: modified sodium hyaluronic acid and carboxymethylcellulose; Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 753
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Stony Brook, New York, United States, 11501
      • SUNY Stony Brook University Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Winthrop University Hospital
• Collaborators: Stony Brook University; Lehigh Valley Hospital
• Investigators: Principal Investigator: Daniel G Kiefer, M.D., Lehigh Valley Health Network

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 29, 2007
• First Submitted That Met QC Criteria: November 29, 2007
• First Posted (Estimated): November 30, 2007

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean section; Adhesion; Seprafilm
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Laxatives; Hyaluronic Acid; Carboxymethylcellulose Sodium
• Other Study ID Numbers: IRB No. 07023; MO1RR10710 (Other Grant/Funding Number: General Clinical Research Center (GCRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO