Status:
COMPLETED
Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
Lead Sponsor:
St. Louis University
Conditions:
Pregnancy
Obese
Eligibility:
FEMALE
14-50 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of t...
Detailed Description
This study will be a prospective randomized-controlled trial. It will take place at a single site at St. Mary's Health Center in Richmond Heights, Missouri. Pregnant women with a BMI ≥ 30 kg/m2 who wi...
Eligibility Criteria
Inclusion
- Pregnant women
- BMI greater than or equal to 30 kg/m squared
- Aged 14-50 years old
- Undergoing non-emergent cesarean section for delivery
Exclusion
- Subjects undergoing emergency Cesarean-section
- Pre-existing concurrent infection other than chorioamnionitis
- State of immunosuppression (ie. HIV, cancer)
- Long-term steroid use (\>2 days)
- Subjects with a BMI \<30 kg/m2
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01826604
Start Date
January 1 2013
End Date
September 1 2014
Last Update
October 3 2016
Active Locations (1)
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1
St. Mary's Health Center
St Louis, Missouri, United States, 63117