Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358592
Recruitment Status : Unknown
Verified May 2013 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : August 1, 2006
Last Update Posted : May 21, 2013
Apple Medical Corporation
Information provided by (Responsible Party):
Thomas Jefferson University

July 31, 2006
August 1, 2006
May 21, 2013
July 2006
Not Provided
operative time
Same as current
Complete list of historical versions of study NCT00358592 on 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
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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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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 Identifier (NCT Number) in Medline.
Unknown status
Same as current
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
Sexes Eligible for Study: Female
15 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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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