Recruiting

Tissue Retractors

Sponsor:

Thomas Jefferson University

Code:

NCT00358592

Conditions

Cesarean Section

Obesity

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Mobius™ retractor

traditional metal retraction instruments

Study Details

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.

Conditions

Cesarean Section

Obesity

Study ID

NCT00358592

Start date

Jul, 2006

Status verified date

May, 2013

Completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Mobius™ retractor

traditional metal retraction instruments

Primary outcome measure

  • operative time [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Jason K Baxter, MD, MSCP

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 21, 2013

Last verified

May, 2013

Keywords

  • surgical instruments
  • cesarean section
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2013-05-21.