Randomized Controlled Trial of Bladder Flap vs.None

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Mountain Area Health Organization Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mountain Area Health Organization Center
ClinicalTrials.gov Identifier:
NCT00470288
First received: May 4, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention
Cesarean Delivery Procedures
Procedure: bladder flap during cesarean section

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bladder Flap vs.None

Resource links provided by NLM:


Further study details as provided by Mountain Area Health Organization Center:

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

Secondary Outcome Measures:
  • estimated blood loss [ Time Frame: immediate ]
  • bladder injuries [ Time Frame: immediate ]
  • other intra-operative complications [ Time Frame: immediate ]
  • intra-operative transfusions [ Time Frame: immediate ]
  • post-operative complications [ Time Frame: post-op hospitalization ]
  • medication use: antibiotics and narcotics [ Time Frame: post-op hospitalization ]
  • duration of post-op hospitalization [ Time Frame: post-op hospitalization ]
  • readmisison post discharge [ Time Frame: 6 weeks post-op ]

Estimated Enrollment: 123
Study Start Date: October 2005
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470288

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

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

Publications:
ClinicalTrials.gov Identifier: NCT00470288     History of Changes
Other Study ID Numbers: 05-10-477
Study First Received: May 4, 2007
Last Updated: May 4, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Mountain Area Health Organization Center:
cesarean delivery
bladder flaps

ClinicalTrials.gov processed this record on August 25, 2014