Randomized Controlled Trial of Bladder Flap vs.None
Recruitment status was Recruiting
|First Received Date ICMJE||May 4, 2007|
|Last Updated Date||May 4, 2007|
|Start Date ICMJE||October 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||operative time: start of surgery to delivery of infant [ Time Frame: immediate: during cesarean surgery ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Randomized Controlled Trial of Bladder Flap vs.None|
|Official Title ICMJE||Randomized Controlled Trial of Bladder Flap vs.None|
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.
1. To compare outcomes in cesarean section patients undergoing bladder flap versus none.
4. Study design (Explicate the nature of the study – observational vs experimental. Differentiate between cohort, case-control, and cross-sectional and randomized clinical trials. For the latter, provide sufficient supporting justification for the experimental arm. If it is a placebo-controlled trial, please state whether clinical equipoise exists between the placebo and experimental arm.) Randomized controlled trial.
Total operating time (continuous) and Time of delivery to end of surgery (continuous) Estimated blood loss (continuous) Post operative fever (categorical) Bladder injury (categorical) Pre- and post-operative pain medication (continuous) and Analog pain scale (continuous)
5. Subject Selection (Include an enumeration of inclusion and exclusion criteria)
MAHEC patients presenting for delivery at Mission Hospitals requiring a cesarean section
Inclusion Exclusion Cesarean section All vaginal deliveries
≥ 35 weeks gestation < 35 weeks gestation Able to provide consent for medical treatment Urgent cesarean section Unable to provide consent for medical treatment Medical complications prohibitive of bladder flap Medical complications prohibitive of no bladder flap
6. Statistical methods, data analysis and interpretation (Include the factors considered in determining an appropriate sample size) Sample size of 100 per group based on an estimated mean difference of 5 minutes on total operating time (study arm 45±12.5 vs. bladder flap arm 50±12.5; Power=080; alpha=0.05; two-tailed).4
Per protocol analysis utilizing analysis of variance or for continuous variables and chi square analysis of categorical variables.
7. Study Procedures (Describe the chronological flow of the study, using schematic diagrams as necessary. Distinguish clearly between treatment-related [medically-indicated] and research-related procedures the subject will undergo)
All OB patients presenting at L&D for delivery will be approached for informed consent. consenting patients for whom a cesarean delivery is medically indicated will be randomized to bladder flap vs. none. Patients unable to consent for medical treatment or not wishing to consent for the project will be excluded. Consenting patients for whom a cesarean is medically indicated will be randomly assigned to bladder flap vs. by previously allocation of subject number. Patients will undergo assigned procedure unless excluded at the discretion of the surgeons who determine the alternate procedure is medically indicated. Patients undergoing the assigned procedure will have all data extracted from hospital medical records and entered into SPSS for a per-protocol analysis.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Condition ICMJE||Cesarean Delivery Procedures|
|Intervention ICMJE||Procedure: bladder flap during cesarean section|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||123|
|Estimated Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00470288|
|Other Study ID Numbers ICMJE||05-10-477|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Mountain Area Health Organization Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Mountain Area Health Organization Center|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP