<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/NCT03009994</url>
  </required_header>
  <id_info>
    <org_study_id>EUR</org_study_id>
    <nct_id>NCT03009994</nct_id>
  </id_info>
  <brief_title>Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cesarean section is one of the most frequently performed major operations worldwide. It&#xD;
      accounts for between 1% and 70% of deliveries depending on the facilities or country&#xD;
      assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private&#xD;
      hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut&#xD;
      university is 51.3% of all deliveries.&#xD;
&#xD;
      Different Operational techniques For cesarean section have been defined aimed at reducing&#xD;
      surgical time, making the surgery easier and more efficient, lowering costs,decreasing the&#xD;
      risk of adverse effects and postoperative morbidity, as well as length of hospital stay.&#xD;
&#xD;
      Also, Intraoperative blood loss is one of important complications during cesarean section. A&#xD;
      systematic review included twenty one studies, in 2011, revealed that increase incidence of&#xD;
      intraoperative blood loss and blood transfusion with increase number of cesarean&#xD;
      deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative&#xD;
      blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of&#xD;
      pregnant women.&#xD;
&#xD;
      After baby born by cesarean section and the placenta has been extracted, uterine incision is&#xD;
      sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization&#xD;
      of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal&#xD;
      cavity (in situ repair). There had been few randomized controlled trials comparing&#xD;
      intraoperative and postoperative morbidity following exteriorization of the uterus with&#xD;
      non-exteriorization. The conclusions drawn from these trials have been conflicting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative blood loss (mL)</measure>
    <time_frame>20 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Hemoglobin (gm/L)</measure>
    <time_frame>20 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of operation (minutes)</measure>
    <time_frame>20 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1024</enrollment>
  <condition>Intrapartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Exteriorization group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non exteriorization group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Uterine incision will be repaired intra abdominally</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Repair of uterine incision</intervention_name>
    <arm_group_label>Exteriorization group</arm_group_label>
    <arm_group_label>Non exteriorization group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exteriorization of the uterus</intervention_name>
    <arm_group_label>Exteriorization group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non exteriorization of the uterus</intervention_name>
    <arm_group_label>Non exteriorization group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in 28 weeks&#xD;
&#xD;
          -  Women who will undergo repeated lower segment cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  First cesarean section&#xD;
&#xD;
          -  Placenta previa.&#xD;
&#xD;
          -  Rupture uterus.&#xD;
&#xD;
          -  Classical caesarean section.(upper segment cesarean section)&#xD;
&#xD;
          -  Sever Preeclampsia.&#xD;
&#xD;
          -  Chorioamnionitis.&#xD;
&#xD;
          -  prolonged or obstructed labour.&#xD;
&#xD;
          -  Fibroid.&#xD;
&#xD;
          -  Polyhydramnios.&#xD;
&#xD;
          -  Multiple pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed k Ali, MD</last_name>
      <phone>+20100553751</phone>
      <email>m_khairy2001@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mohamad sayed abdellah</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03009994
org study id: EUR
nct id: NCT03009994
lead sponsor: 
has dmc: No
Cesarean section is one of the most frequently performed major operations worldwide. It
      accounts for between 1% and 70% of deliveries depending on the facilities or country
      assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private
      hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut
      university is 51.3% of all deliveries.

      Different Operational techniques For cesarean section have been defined aimed at reducing
      surgical time, making the surgery easier and more efficient, lowering costs,decreasing the
      risk of adverse effects and postoperative morbidity, as well as length of hospital stay.

      Also, Intraoperative blood loss is one of important complications during cesarean section. A
      systematic review included twenty one studies, in 2011, revealed that increase incidence of
      intraoperative blood loss and blood transfusion with increase number of cesarean
      deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative
      blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of
      pregnant women.

      After baby born by cesarean section and the placenta has been extracted, uterine incision is
      sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization
      of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal
      cavity (in situ repair). There had been few randomized controlled trials comparing
      intraoperative and postoperative morbidity following exteriorization of the uterus with
      non-exteriorization. The conclusions drawn from these trials have been conflicting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Intraoperative blood loss (mL)
time frame: 20 minutes
measure: Postoperative Hemoglobin (gm/L)
time frame: 20 minutes
measure: Duration of operation (minutes)
time frame: 20 minutes
arm group label: Exteriorization group
arm group type: Other
description: After delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following.
arm group label: Non exteriorization group
arm group type: Other
description: Uterine incision will be repaired intra abdominally
intervention type: Procedure
intervention name: Repair of uterine incision
arm group label: Exteriorization group
arm group label: Non exteriorization group
intervention type: Procedure
intervention name: Exteriorization of the uterus
arm group label: Exteriorization group
intervention type: Procedure
intervention name: Non exteriorization of the uterus
arm group label: Non exteriorization group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mohamad sayed abdellah
investigator title: Prof
mesh term: Hemorrhage
sharing ipd: No