Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358592
Status:
UNKNOWN
Last Update Posted:
2013-05-21
First Post:
2006-07-31
Brief Title:
Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Randomized Controlled Trial of the Efficacy of the Mobius Retractor in Performing Cesarean Sections in Patients With BMI 35kgm2
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None