Clinical trial NCT00565643: Seprafilm® Adhesion Barrier and Cesarean Delivery
Official title: A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesions
Cesarean Section
Delivery, Obstetric
Keywords: Adhesion
Seprafilm
Cesarean section
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
Collaborators: name: Stony Brook University
name: Lehigh Valley Hospital
First posted: 2007-11-30
Enrollment: 753
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Adhesions
timeFrame: 3 to 5 years
measure: Adhesion Score
timeFrame: 3 to 5 years
Secondary outcomes:
measure: Post-operative Hemoglobin
timeFrame: 1 to 5 years
measure: Post-operative White Blood Cell Count
timeFrame: 1 to 5 years
measure: Post-Operative Complications
timeFrame: 1 to 5 years
measure: Post-operative Maximum Temperature Following Randomization
timeFrame: 1 to 5 years
measure: Operative Times at Subsequent Delivery
timeFrame: 3 to 5 years
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook University Hospital
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Health Network
name: Daniel G Kiefer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: