Status:
WITHDRAWN
The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
Lead Sponsor:
Geisinger Clinic
Collaborating Sponsors:
Clinical Innovations
Conditions:
Obesity
Eligibility:
FEMALE
Phase:
NA
Brief Summary
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to sil...
Detailed Description
The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the ...
Eligibility Criteria
Inclusion
- Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
- Requires panniculus retractor for cesarean delivery, as determined by the surgeon
- Non-emergent cesarean delivery
- Spinal or epidural anesthesia
- Low transverse skin incision
- Gestational age equal to or more than 32 weeks 0 days
- Singleton pregnancy
- Three or less previous cesarean deliveries.
- English speaking
Exclusion
- Use of Alexis or any other retractor
- General anesthesia
- Fetal demise
- Placenta previa
- History of bariatric surgery
- Adhesive allergy
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04458415
Start Date
June 1 2021
End Date
April 30 2022
Last Update
August 11 2021
Active Locations (1)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17821