Seprafilm® Adhesion Barrier and Cesarean Delivery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stony Brook University
Lehigh Valley Hospital
Information provided by (Responsible Party):
Daniel Kiefer, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00565643
First received: November 29, 2007
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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), patient perception of pelvic pain, and a cost-effectiveness analysis.


Condition Intervention Phase
Adhesions
Cesarean Section
Delivery, Obstetric
Device: modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier)
Device: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. [ Time Frame: 3 to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time), patient perception of pelvic pain, and a cost-effectiveness analysis. [ Time Frame: 1 to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 753
Study Start Date: November 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier)
Adhesion barrier applied at the time of initial cesarean delivery
Other Name: Seprafilm Adhesion Barrier
Placebo Comparator: B Device: Placebo
Routine abdominal closure without placement of adhesion barrier

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 and to assess blinding effectiveness. Patients will then be contacted by mail survey periodically (approximately every six months) to assess their pregnancy/fertility status, pregnancy plans, and complete a brief survey on pelvic pain.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • Infertility resulting in > 2 years of treatment to achieve current pregnancy
  • Known allergy to hyaluronic acid
  • Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565643

Locations
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, 18105
Sponsors and Collaborators
Winthrop University Hospital
Stony Brook University
Lehigh Valley Hospital
Investigators
Principal Investigator: Daniel G Kiefer, M.D. Lehigh Valley Health Network
  More Information

No publications provided

Responsible Party: Daniel Kiefer, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00565643     History of Changes
Other Study ID Numbers: IRB No. 07023, 07023
Study First Received: November 29, 2007
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Adhesion
Seprafilm
Cesarean section

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Carboxymethylcellulose Sodium
Hyaluronic Acid
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014