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Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Thomas Jefferson University logo

Thomas Jefferson University

Status

Unknown

Conditions

Cesarean Section
Obesity

Treatments

Device: Mobius™ retractor
Device: traditional metal retraction instruments

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Edward J Hayes, MD; Jason K Baxter, MD, MSCP

Data sourced from clinicaltrials.gov

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