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Randomized Controlled Trial of Bladder Flap vs.None

NCT00470288 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2007-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Cesarean Delivery Procedures

Interventions

PROCEDURE

bladder flap during cesarean section

Sponsors & Collaborators

  • Mountain Area Health Organization Center

    lead OTHER

Principal Investigators

  • Eric C Helms, MD · MAHEC OB/GYN

  • Shelley L Galvin, MA · MAHEC OB/GYN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Completion
2007-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470288 on ClinicalTrials.gov