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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.
 
ClinicalTrials.gov Identifier: NCT00565643
Recruitment Status : Completed
First Posted : November 30, 2007
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborators:
Stony Brook University
Lehigh Valley Hospital
Information provided by (Responsible Party):
Daniel Kiefer, Winthrop University Hospital

Tracking Information
First Submitted Date  ICMJE November 29, 2007
First Posted Date  ICMJE November 30, 2007
Results First Submitted Date  ICMJE December 30, 2015
Results First Posted Date  ICMJE April 22, 2016
Last Update Posted Date April 22, 2016
Study Start Date  ICMJE November 2007
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
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 ]
Change History Complete list of historical versions of study NCT00565643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seprafilm® Adhesion Barrier and Cesarean Delivery
Official Title  ICMJE A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Adhesions
  • Cesarean Section
  • Delivery, Obstetric
Intervention  ICMJE
  • Device: modified sodium hyaluronic acid and carboxymethylcellulose
    Adhesion barrier applied at the time of initial cesarean delivery
    Other Name: Seprafilm Adhesion Barrier
  • Device: Placebo
    Routine abdominal closure without placement of adhesion barrier
Study Arms  ICMJE
  • Experimental: HA-CMC Group
    Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier
    Intervention: Device: modified sodium hyaluronic acid and carboxymethylcellulose
  • Placebo Comparator: Routine Closure Group
    Routine Closure without placement of an adhesion barrier
    Intervention: Device: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)
753
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2007)
2250
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00565643
Other Study ID Numbers  ICMJE IRB No. 07023
MO1RR10710 ( Other Grant/Funding Number: General Clinical Research Center (GCRC) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Kiefer, Winthrop University Hospital
Study Sponsor  ICMJE Winthrop University Hospital
Collaborators  ICMJE
  • Stony Brook University
  • Lehigh Valley Hospital
Investigators  ICMJE
Principal Investigator: Daniel G Kiefer, M.D. Lehigh Valley Health Network
PRS Account Winthrop University Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP