Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

This study is currently recruiting participants.
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

July 31, 2006
May 20, 2013
July 2006
Not Provided
operative time
Same as current
Complete list of historical versions of study NCT00358592 on ClinicalTrials.gov Archive Site
  • blood loss
  • number of transfusions
  • infectious morbidity
  • incision length
  • intra and postoperative antiemetic medication use
  • intra and postoperative pain medication use
  • surgeon satisfaction
Same as current
Not Provided
Not Provided
 
Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Cesarean Section
  • Obesity
  • Device: Mobius™ retractor
  • Device: traditional metal retraction instruments
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2014
Not Provided

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
Female
15 Years and older
No
Contact: Jason K Baxter, MD, MSCP (215) 955-9238 jason.baxter@jefferson.edu
Contact: Edward J Hayes, MD (215) 955-9196 edwardjhayes@comcast.net
United States
 
NCT00358592
06C.78
Not Provided
Thomas Jefferson University
Thomas Jefferson University
Apple Medical Corporation
Principal Investigator: Jason K Baxter, MD, MSCP Thomas Jefferson University
Thomas Jefferson University
May 2013

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