<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723605</url>
  </required_header>
  <id_info>
    <org_study_id>32012</org_study_id>
    <nct_id>NCT01723605</nct_id>
  </id_info>
  <brief_title>Insitu Repair Versus Uterine Exeriorization During Cesarean Section</brief_title>
  <official_title>Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two types of uterine repair described during cesarean section, the investigators will try to&#xD;
      compare between the two techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the&#xD;
      uterus during uterine closure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel movement</measure>
    <time_frame>12 hours</time_frame>
    <description>Regain of bowel movement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgery duration</measure>
    <time_frame>2 hours</time_frame>
    <description>The duration of intraoperative surgey</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Complications; Cesarean Section</condition>
  <arm_group>
    <arm_group_label>insitu repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>insitu repair of the uterine incision during caeserean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exteriorisation of the uretus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>uterine closure during caeserian section with exteriorisation of the uterus</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>insitu repair</intervention_name>
    <description>closure of the uterine incision while the uterus initu</description>
    <arm_group_label>insitu repair</arm_group_label>
    <other_name>repair insitu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>exteriorisation of the uterus</intervention_name>
    <description>uterine closure while the uterus is exteriorised</description>
    <arm_group_label>exteriorisation of the uretus</arm_group_label>
    <other_name>uterine closure with exteriorisation of the uterus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  bleeding tendency&#xD;
&#xD;
          -  abnormal placentation&#xD;
&#xD;
          -  preeclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed El-khayat</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Cairo</city>
        <zip>12211</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>December 28, 2013</last_update_submitted>
  <last_update_submitted_qc>December 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Waleed El-khayat</investigator_full_name>
    <investigator_title>Assisstant professor</investigator_title>
  </responsible_party>
  <keyword>insitu repair</keyword>
  <keyword>intestinal motility</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723605
org study id: 32012
nct id: NCT01723605
lead sponsor: 
has dmc: Yes
Two types of uterine repair described during cesarean section, the investigators will try to
      compare between the two techniques.
Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the
      uterus during uterine closure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Bowel movement
time frame: 12 hours
description: Regain of bowel movement
measure: Surgery duration
time frame: 2 hours
description: The duration of intraoperative surgey
arm group label: insitu repair
arm group type: Experimental
description: insitu repair of the uterine incision during caeserean section
arm group label: exteriorisation of the uretus
arm group type: Active Comparator
description: uterine closure during caeserian section with exteriorisation of the uterus
intervention type: Procedure
intervention name: insitu repair
description: closure of the uterine incision while the uterus initu
arm group label: insitu repair
other name: repair insitu
intervention type: Procedure
intervention name: exteriorisation of the uterus
description: uterine closure while the uterus is exteriorised
arm group label: exteriorisation of the uretus
other name: uterine closure with exteriorisation of the uterus
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Waleed El-khayat
role: Study Chair
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Waleed El-khayat
investigator title: Assisstant professor