Insitu Repair Versus Uterine Exeriorization During Cesarean Section

December 28, 2013 updated by: Waleed El-khayat, Cairo University

Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12211
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  • liver disease
  • kidney disease
  • bleeding tendency
  • abnormal placentation
  • preeclampsia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • uterine closure with exteriorisation of the uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel movement
Time Frame: 12 hours
Regain of bowel movement
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery duration
Time Frame: 2 hours
The duration of intraoperative surgey
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Waleed El-khayat, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 28, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 32012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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