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Insitu Repair Versus Uterine Exeriorization During Cesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723605
First Posted: November 8, 2012
Last Update Posted: December 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Waleed El-khayat, Cairo University:

Primary Outcome Measures:
  • Bowel movement [ Time Frame: 12 hours ]
    Regain of bowel movement


Secondary Outcome Measures:
  • Surgery duration [ Time Frame: 2 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes 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
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): NCT01723605


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Waleed El-khayat, Assisstant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01723605     History of Changes
Other Study ID Numbers: 32012
First Submitted: November 4, 2012
First Posted: November 8, 2012
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Waleed El-khayat, Cairo University:
insitu repair
intestinal motility