Seprafilm® Adhesion Barrier and Cesarean Delivery

NYU Langone Hospitals

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Adhesions; Delivery, Obstetric

Treatments: Device: Placebo; Device: modified sodium hyaluronic acid and carboxymethylcellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00565643

MO1RR10710 (Other Grant/Funding Number)

IRB No. 07023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 753 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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753 participants in 2 patient groups, including a placebo group

HA-CMC Group

Experimental group

Description:

Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier

Treatment:

Device: modified sodium hyaluronic acid and carboxymethylcellulose

Routine Closure Group

Placebo Comparator group

Description:

Routine Closure without placement of an adhesion barrier

Treatment:

Device: Placebo