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Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Apple Medical Corporation
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Obesity Device: Mobius™ retractor Device: traditional metal retraction instruments Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : July 2006
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources




Primary Outcome Measures :
  1. operative time

Secondary Outcome Measures :
  1. blood loss
  2. number of transfusions
  3. infectious morbidity
  4. incision length
  5. intra and postoperative antiemetic medication use
  6. intra and postoperative pain medication use
  7. surgeon satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00358592     History of Changes
Other Study ID Numbers: 06C.78
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

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