Cesarean Section, Obesity
Conditions
Keywords
surgical instruments, cesarean section, obesity
Brief summary
This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.
Detailed description
The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this added exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* pregnant women undergoing non-urgent cesarean delivery
Exclusion criteria
* women undergoing urgent cesarean delivery * BMI \<35kg/m2 * women undergoing vaginal delivery * positive urine drug screen or known history of methadone maintenance or substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| operative time | — |
Secondary
| Measure | Time frame |
|---|---|
| surgeon satisfaction | — |
| infectious morbidity | — |
| incision length | — |
| intra and postoperative pain medication use | — |
| blood loss | — |
| number of transfusions | — |
| intra and postoperative antiemetic medication use | — |
Countries
United States