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Insitu Repair Versus Uterine Exeriorization During Cesarean Section

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ClinicalTrials.gov Identifier: NCT01723605
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University

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

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. Surgery duration [ Time Frame: 2 hours ]
    The duration of intraoperative surgey



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

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

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 Posted: November 8, 2012    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

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