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Seprafilm® Adhesion Barrier and Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565643
Recruitment Status : Completed
First Posted : November 30, 2007
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Stony Brook University
Lehigh Valley Hospital
Information provided by (Responsible Party):
Daniel Kiefer, Winthrop University Hospital

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).

Condition or disease Intervention/treatment Phase
Adhesions Cesarean Section Delivery, Obstetric Device: modified sodium hyaluronic acid and carboxymethylcellulose Device: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 753 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
Study Start Date : November 2007
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Device: Placebo
Routine abdominal closure without placement of adhesion barrier

Primary Outcome Measures :
  1. Incidence of Adhesions [ Time Frame: 3 to 5 years ]
    The Percentage of participants with one or more adhesions, regardless of the extent or severity

  2. 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).

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Post-Operative Complications [ Time Frame: 1 to 5 years ]
    Percentage of patients experiencing any of the predefined post-operative complications following randomization

  4. Post-operative Maximum Temperature Following Randomization [ Time Frame: 1 to 5 years ]
    Maximum temperature of patient, >24 hours following randomization delivery

  5. Operative Times at Subsequent Delivery [ Time Frame: 3 to 5 years ]
    Amount of time spent at the time of the subsequent delivery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565643

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

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Responsible Party: Daniel Kiefer, Principal Investigator, Winthrop University Hospital Identifier: NCT00565643    
Other Study ID Numbers: IRB No. 07023
MO1RR10710 ( Other Grant/Funding Number: General Clinical Research Center (GCRC) )
First Posted: November 30, 2007    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel Kiefer, Winthrop University Hospital:
Cesarean section
Additional relevant MeSH terms:
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Tissue Adhesions
Pathologic Processes
Carboxymethylcellulose Sodium
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Gastrointestinal Agents