Seprafilm® Adhesion Barrier and Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565643
• Other study ID #: IRB No. 07023
• Secondary ID: MO1RR10710
• Status: Completed
• Phase: Phase 4
• Start date: November 2007
• Est. completion date: October 2014

Study information

• Verified date: April 2024
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesions
• Cesarean Section
• Delivery, Obstetric
• Tissue Adhesions

Intervention

Device:
• modified sodium hyaluronic acid and carboxymethylcellulose
Adhesion barrier applied at the time of initial cesarean delivery
• Placebo
Routine abdominal closure without placement of adhesion barrier

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Winthrop University Hospital	Mineola	New York
United States	SUNY Stony Brook University Hospital	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Winthrop University Hospital	Lehigh Valley Hospital, Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adhesions	The Percentage of participants with one or more adhesions, regardless of the extent or severity	3 to 5 years
Primary	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	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
Secondary	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
Secondary	Post-Operative Complications	Percentage of patients experiencing any of the predefined post-operative complications following randomization	1 to 5 years
Secondary	Post-operative Maximum Temperature Following Randomization	Maximum temperature of patient, >24 hours following randomization delivery	1 to 5 years
Secondary	Operative Times at Subsequent Delivery	Amount of time spent at the time of the subsequent delivery	3 to 5 years