Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

May 20, 2013 updated by: Thomas Jefferson University

Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2

This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason K Baxter, MD, MSCP
        • Sub-Investigator:
          • Edward J Hayes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women undergoing non-urgent cesarean delivery

Exclusion Criteria:

  • women undergoing urgent cesarean delivery
  • BMI <35kg/m2
  • women undergoing vaginal delivery
  • positive urine drug screen or known history of methadone maintenance or substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
operative time

Secondary Outcome Measures

Outcome Measure
blood loss
number of transfusions
infectious morbidity
incision length
intra and postoperative antiemetic medication use
intra and postoperative pain medication use
surgeon satisfaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Apple Medical Corporation

Investigators

  • Principal Investigator: Jason K Baxter, MD, MSCP, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

July 31, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06C.78

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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