N/A
Completed N=301
Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
Pregnancy · Obese
Source: ClinicalTrials.gov NCT01826604 ↗
Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Wound Infection or Disruption — 38; 37 participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Infection or Disruption |
38; 37 | — |
| SECONDARY Secondary Outcomes Will Include the Differences Between the Two Groups. |
20; 19; 14; 13; 6; 6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01826604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.