Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Thomas Jefferson University
Sponsor:
Collaborator:
Apple Medical Corporation
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00358592
First received: July 31, 2006
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cesarean Section
Obesity
Device: Mobius™ retractor
Device: traditional metal retraction instruments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

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

Estimated Enrollment: 60
Study Start Date: July 2006
Estimated Study Completion Date: June 2014
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358592

Contacts
Contact: Jason K Baxter, MD, MSCP (215) 955-9238 jason.baxter@jefferson.edu
Contact: Edward J Hayes, MD (215) 955-9196 edwardjhayes@comcast.net

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jason K Baxter, MD, MSCP    215-955-9238    jason.baxter@jefferson.edu   
Contact: Edward J Hayes, MD    (215) 955-9196    edwardjhayes@comcast.net   
Principal Investigator: Jason K Baxter, MD, MSCP         
Sub-Investigator: Edward J Hayes, MD         
Sponsors and Collaborators
Thomas Jefferson University
Apple Medical Corporation
Investigators
Principal Investigator: Jason K Baxter, MD, MSCP Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00358592     History of Changes
Other Study ID Numbers: 06C.78
Study First Received: July 31, 2006
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
surgical instruments
cesarean section
obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014