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Terminated
NCT03651076
Traxi Panniculus Retractor for Cesarean Delivery
Conditions: Obesity, Morbid, Cesarean Section Complications
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 142
Sponsor: Beth Israel Deaconess Medical Center
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.
Eligibility Criteria
Inclusion Criteria:
* Pregnant
* BMI greater than or equal to 40 kg/m\^2
* Undergoing non-emergent cesarean delivery
* Able and willing to provide written, informed consent
* Singleton gestation
Exclusion Criteria:
* Fetal demise
* Disruption of abdominal skin (infection, rash, abrasion, laceration)
* Known adhesive allergy
Source: ClinicalTrials.gov (NCT03651076). StuddyBuddy aggregates publicly available trial information.
