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Randomized Controlled Trial of Bladder Flap vs.None

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ClinicalTrials.gov Identifier: NCT00470288
Recruitment Status : Unknown
Verified April 2007 by Mountain Area Health Organization Center.
Recruitment status was:  Recruiting
First Posted : May 7, 2007
Last Update Posted : May 7, 2007
Information provided by:
Mountain Area Health Organization Center

Brief 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.

Condition or disease Intervention/treatment
Cesarean Delivery Procedures Procedure: bladder flap during cesarean section

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bladder Flap vs.None
Study Start Date : October 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Primary Outcome Measures :
  1. operative time: start of surgery to delivery of infant [ Time Frame: immediate: during cesarean surgery ]

Secondary Outcome Measures :
  1. estimated blood loss [ Time Frame: immediate ]
  2. bladder injuries [ Time Frame: immediate ]
  3. other intra-operative complications [ Time Frame: immediate ]
  4. intra-operative transfusions [ Time Frame: immediate ]
  5. post-operative complications [ Time Frame: post-op hospitalization ]
  6. medication use: antibiotics and narcotics [ Time Frame: post-op hospitalization ]
  7. duration of post-op hospitalization [ Time Frame: post-op hospitalization ]
  8. readmisison post discharge [ Time Frame: 6 weeks post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470288

Contact: Eric C Helms, MD 828-771-5501 Eric.helms@mahec.net
Contact: Shelley L Galvin, MA 828-771-5501 Shelley.Galvin@mahec.net

United States, North Carolina
Mission Hospitals Recruiting
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Mountain Area Health Organization Center
Principal Investigator: Eric C Helms, MD MAHEC OB/GYN
Study Director: Shelley L Galvin, MA MAHEC OB/GYN