Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section

Completed · Not applicable

Conditions studied: Pregnancy, Obese

In brief

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 the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held retractors (control group). We will determine if there is any difference in surgical site infection or wound disruption rates. We will also determine if there is a difference in the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rate between the two groups.

Key facts

Study ID

NCT01826604

Run by

St. Louis University

People needed

301

Starts

2013-01-01

Expected to finish

2014-09-01

Last updated by the study team

2016-10-03

Who can join

Age: 14 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women
• BMI greater than or equal to 30 kg/m squared
• Aged 14-50 years old
• Undergoing non-emergent cesarean section for delivery

You may not qualify if…

• 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

Where it is running

• St. Mary's Health Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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