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NCT Number: NCT00565643

Seprafilm® Adhesion Barrier and Cesarean Delivery

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).

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Key information

Conditions

Adhesions Cesarean Section Cicatrix Delivery, Obstetric Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Winthrop University Hospital, Mineola, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified sodium hyaluronic acid and carboxymethylcellulose

Device

Adhesion barrier applied at the time of initial cesarean delivery

Other names: Seprafilm Adhesion Barrier

PLACEBO

Device

Routine abdominal closure without placement of adhesion barrier

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Collaborators

  • Lehigh Valley Hospital
  • Stony Brook University

Registry information

Official study title

A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2007
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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