Insitu Repair Versus Uterine Exeriorization During Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01723605
First received: November 4, 2012
Last updated: December 28, 2013
Last verified: December 2013
  Purpose

Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.


Condition Intervention Phase
Complications; Cesarean Section
Procedure: insitu repair
Procedure: exteriorisation of the uterus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Bowel movement [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
    Regain of bowel movement


Secondary Outcome Measures:
  • Surgery duration [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    The duration of intraoperative surgey


Enrollment: 1000
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insitu repair
insitu repair of the uterine incision during caeserean section
Procedure: insitu repair
closure of the uterine incision while the uterus initu
Other Name: repair insitu
Active Comparator: exteriorisation of the uretus
uterine closure during caeserian section with exteriorisation of the uterus
Procedure: exteriorisation of the uterus
uterine closure while the uterus is exteriorised
Other Name: uterine closure with exteriorisation of the uterus

Detailed Description:

Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  • liver disease
  • kidney disease
  • bleeding tendency
  • abnormal placentation
  • preeclampsia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723605

Locations
Egypt
Faculty of medicine
Cairo, Egypt, 12211
Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Waleed El-khayat Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Assisstant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01723605     History of Changes
Other Study ID Numbers: 32012
Study First Received: November 4, 2012
Last Updated: December 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
insitu repair
intestinal motility

ClinicalTrials.gov processed this record on April 16, 2014