Seprafilm® Adhesion Barrier and Cesarean Delivery
|Adhesions Cesarean Section Delivery, Obstetric||Device: modified sodium hyaluronic acid and carboxymethylcellulose Device: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery|
- Incidence of Adhesions [ Time Frame: 3 to 5 years ]The Percentage of participants with one or more adhesions, regardless of the extent or severity
- Adhesion Score [ Time Frame: 3 to 5 years ]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).
- Post-operative Hemoglobin [ Time Frame: 1 to 5 years ]Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
- Post-operative White Blood Cell Count [ Time Frame: 1 to 5 years ]Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
- Post-Operative Complications [ Time Frame: 1 to 5 years ]Percentage of patients experiencing any of the predefined post-operative complications following randomization
- Post-operative Maximum Temperature Following Randomization [ Time Frame: 1 to 5 years ]Maximum temperature of patient, >24 hours following randomization delivery
- Operative Times at Subsequent Delivery [ Time Frame: 3 to 5 years ]Amount of time spent at the time of the subsequent delivery
|Study Start Date:||November 2007|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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 Name: Seprafilm Adhesion Barrier
Placebo Comparator: Routine Closure Group
Routine Closure without placement of an adhesion barrier
Routine abdominal closure without placement of adhesion barrier
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:
- Group A - Placement of Seprafilm® prior to abdominal closure
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565643
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|SUNY Stony Brook University Hospital|
|Stony Brook, New York, United States, 11501|
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18103|
|Principal Investigator:||Daniel G Kiefer, M.D.||Lehigh Valley Health Network|