Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section, Obesity

Intervention / Treatment
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* Device: Mobius™ retractor
* Device: traditional metal retraction instruments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mobius™ retractor|nan|
|Device: traditional metal retraction instruments|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  |  | 
| number of transfusions |  |  | 
| infectious morbidity |  |  | 
| incision length |  |  | 
| intra and postoperative antiemetic medication use |  |  | 
| intra and postoperative pain medication use |  |  | 
| surgeon satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical instruments, cesarean section, obesity