Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Cesarean Section Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Mobius™ retractor

Intervention Type DEVICE

traditional metal retraction instruments

Intervention Type DEVICE

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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No