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Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Primary Purpose

Cesarean Section, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobius™ retractor
traditional metal retraction instruments
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring surgical instruments, cesarean section, obesity

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson UniversityRecruiting

Outcomes

Primary Outcome Measures

operative time

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2006
Last Updated
May 20, 2013
Sponsor
Thomas Jefferson University
Collaborators
Apple Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00358592
Brief Title
Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
Official Title
Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Apple Medical Corporation

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Obesity
Keywords
surgical instruments, cesarean section, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Mobius™ retractor
Intervention Type
Device
Intervention Name(s)
traditional metal retraction instruments
Primary Outcome Measure Information:
Title
operative time
Secondary Outcome Measure Information:
Title
blood loss
Title
number of transfusions
Title
infectious morbidity
Title
incision length
Title
intra and postoperative antiemetic medication use
Title
intra and postoperative pain medication use
Title
surgeon satisfaction

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason K Baxter, MD, MSCP
Phone
(215) 955-9238
Email
jason.baxter@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edward J Hayes, MD
Phone
(215) 955-9196
Email
edwardjhayes@comcast.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason K Baxter, MD, MSCP
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason K Baxter, MD, MSCP
Phone
215-955-9238
Email
jason.baxter@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Edward J Hayes, MD
Phone
(215) 955-9196
Email
edwardjhayes@comcast.net
First Name & Middle Initial & Last Name & Degree
Jason K Baxter, MD, MSCP
First Name & Middle Initial & Last Name & Degree
Edward J Hayes, MD

12. IPD Sharing Statement

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Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

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