Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Obesity Clinical Trial

Official title:

Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00358592
• Other study ID #: 06C.78
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2006
• Last updated: May 20, 2013
• Start date: July 2006
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: Thomas Jefferson University
• Contact: Jason K Baxter, MD, MSCP
• Phone: (215) 955-9238
• Email: jason.baxter[@]jefferson.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section
• Obesity

Intervention

Device:
• Mobius™ retractor

• traditional metal retraction instruments

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Apple Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time
Secondary	blood loss
Secondary	number of transfusions
Secondary	infectious morbidity
Secondary	incision length
Secondary	intra and postoperative antiemetic medication use
Secondary	intra and postoperative pain medication use
Secondary	surgeon satisfaction