Seprafilm® Adhesion Barrier and Cesarean Delivery

NCT ID: NCT00565643

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 753 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Adhesions; Cesarean Section; Delivery, Obstetric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HA-CMC Group

Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier

Group Type: EXPERIMENTAL

modified sodium hyaluronic acid and carboxymethylcellulose

Intervention Type: DEVICE

Adhesion barrier applied at the time of initial cesarean delivery

Routine Closure Group

Routine Closure without placement of an adhesion barrier

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Routine abdominal closure without placement of adhesion barrier

Interventions

modified sodium hyaluronic acid and carboxymethylcellulose

Adhesion barrier applied at the time of initial cesarean delivery

Intervention Type: DEVICE

Placebo

Routine abdominal closure without placement of adhesion barrier

Intervention Type: DEVICE

Other Intervention Names

Seprafilm Adhesion Barrier

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: collaborator

Lehigh Valley Hospital

OTHER

Sponsor Role: collaborator

Winthrop University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel Kiefer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel G Kiefer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Health Network

Locations

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

Countries

United States

Other Identifiers

MO1RR10710

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB No. 07023

Identifier Type: -

Identifier Source: org_study_id