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| Sponsors and Collaborators: |
Thomas Jefferson University Apple Medical Corporation |
|---|---|
| Information provided by: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00358592 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cesarean Section Obesity |
Device: Mobius™ retractor Device: traditional metal retraction instruments |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2 |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jason K Baxter, MD, MSCP | (215) 955-9238 | jason.baxter@jefferson.edu |
| Contact: Edward J Hayes, MD | (215) 955-9196 | edwardjhayes@comcast.net |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Jason K Baxter, MD, MSCP 215-955-9238 jason.baxter@jefferson.edu | |
| Contact: Edward J Hayes, MD (215) 955-9196 edwardjhayes@comcast.net | |
| Principal Investigator: Jason K Baxter, MD, MSCP | |
| Sub-Investigator: Edward J Hayes, MD | |
| Principal Investigator: | Jason K Baxter, MD, MSCP | Thomas Jefferson University |
More Information
| Study ID Numbers: | 06C.78 |
| Study First Received: | July 31, 2006 |
| Last Updated: | July 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00358592 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
surgical instruments cesarean section obesity |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
