Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Not Applicable

• Conditions: Cesarean Section; Obesity

• Registration Number: NCT00358592
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operative time

Secondary Outcome Measures

Name	Time	Method
blood loss
infectious morbidity
number of transfusions
incision length
intra and postoperative antiemetic medication use
intra and postoperative pain medication use
surgeon satisfaction

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States