Randomized Controlled Trial of Bladder Flap vs.None

Status unconfirmed · Not applicable

Conditions studied: Cesarean Delivery Procedures

In brief

Objective: To compare outcomes in cesarean section patients undergoing bladder flap versus none. Hypotheses: Operative time will be reduced with the elimination of a bladder flap during cesarean delivery and intra-operative and post-operative morbidity will not be significantly different. Patients \>= 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap vs. none. Primary outcome is operative time (start to delivery); secondary outcomes include: injuries, EBL, intra-operative and post-operative complications,pain medication, hospital stay duration.

Key facts

Study ID

NCT00470288

Run by

Mountain Area Health Organization Center

People needed

123

Starts

2005-10-01

Expected to finish

2007-06-01

Last updated by the study team

2007-05-07

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Cesarean delivery at >=35 weeks gestation;
• Able to provide informed consent

You may not qualify if…

• Vaginal delivery;
• Delivery < 35 weeks gestation;
• STAT surgery;
• Unable to provide consent;
• Medical complication/condition incompatable with random asiignment

Where it is running

• Mission Hospitals — Asheville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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