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Seprafilm® Adhesion Barrier and Cesarean Delivery
This study is currently recruiting participants.
Verified by Winthrop University Hospital, June 2008
Sponsors and Collaborators: Winthrop University Hospital
Stony Brook University
Lehigh Valley Hospital
Information provided by: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00565643
  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 IV

MedlinePlus related topics: Adhesions Cesarean Section Childbirth Pelvic Pain
Drug Information available for: Carboxymethylcellulose Hyaluronate Sodium Hyaluronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery

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 ]

Estimated Enrollment: 1800
Study Start Date: November 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Device: modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier)
Adhesion barrier applied at the time of initial cesarean delivery
B: Placebo Comparator 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 to 40 Years
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 18-40
  • 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

Contacts
Contact: Daniel G Kiefer, M.D. 631-444-8411 dkiefer@notes.cc.sunysb.edu

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Graham Ashmead, M.D.     516-663-8661     GAshmead@winthrop.org    
SUNY Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11501
Contact: Daniel Kiefer, M.D.     631-444-8411     dkiefer@notes.cc.sunysb.edu    
United States, Pennsylvania
Lehigh Valley Hospital Not yet recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Orion Rust, MD     610-402-8501     orion.rust@lvh.com    
Sponsors and Collaborators
Winthrop University Hospital
Stony Brook University
Lehigh Valley Hospital
Investigators
Principal Investigator: Daniel G Kiefer, M.D. SUNY Stony Brook University
  More Information

Responsible Party: Winthrop-Unviersity Hospital ( Daniel Kiefer, MD )
Study ID Numbers: IRB No. 07023, 07023
Study First Received: November 29, 2007
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00565643  
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Adhesion
Seprafilm
Cesarean section

Study placed in the following topic categories:
Hyaluronic Acid
Adhesions

Additional relevant MeSH terms:
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009