<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/NCT03824873</url>
  </required_header>
  <id_info>
    <org_study_id>AS1862</org_study_id>
    <nct_id>NCT03824873</nct_id>
  </id_info>
  <brief_title>Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta</brief_title>
  <official_title>Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      40 pregnant females at term diagnosed with morbidly adherent placenta and planned for&#xD;
      elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac&#xD;
      ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of blood loss</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of Blood transfusion needed in mililiters</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of hemoglobin</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of hematocrit</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of injury of important structures during operation</measure>
    <time_frame>intraoperative</time_frame>
    <description>incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Blood Loss</condition>
  <arm_group>
    <arm_group_label>internal iliac artery ligation + cesarean hysterectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>cesarean hysterectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Internal iliac artery ligation</intervention_name>
    <description>Internal iliac artery ligation and cesarean hysterectomy</description>
    <arm_group_label>internal iliac artery ligation + cesarean hysterectomy</arm_group_label>
    <other_name>cesarean hysterectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cesarean hysterectomy</intervention_name>
    <description>cesarean hysterectomy</description>
    <arm_group_label>cesarean hysterectomy</arm_group_label>
    <arm_group_label>internal iliac artery ligation + cesarean hysterectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Placenta previa accreta&#xD;
&#xD;
          -  Previous 2 cesarean section&#xD;
&#xD;
          -  completed her family&#xD;
&#xD;
          -  Hemoglobin &gt; 11 gm/dl&#xD;
&#xD;
          -  Elective cesarean hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia ( Hemoglobin &lt; 11 gm/dl)&#xD;
&#xD;
          -  Not completed her family&#xD;
&#xD;
          -  BMI &gt; 35 Kg/m2&#xD;
&#xD;
          -  Bleeding tendency&#xD;
&#xD;
          -  Emergengy cesarean section&#xD;
&#xD;
          -  Thrombophilia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed S Sweed, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Internal iliac artery</keyword>
  <keyword>Internal iliac artery ligation</keyword>
  <keyword>Placenta previa</keyword>
  <keyword>Placenta accreta</keyword>
  <keyword>cesarean hysterectomy</keyword>
  <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/NCT03824873
org study id: AS1862
nct id: NCT03824873
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for
      elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac
      ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Amount of blood loss
time frame: intraoperative
measure: Amount of Blood transfusion needed in mililiters
time frame: 24 hours
measure: change of hemoglobin
time frame: 24 hours
measure: change of hematocrit
time frame: 24 hours
measure: operative time
time frame: intraoperative
measure: incidence of injury of important structures during operation
time frame: intraoperative
description: incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury
arm group label: internal iliac artery ligation + cesarean hysterectomy
arm group type: Active Comparator
arm group label: cesarean hysterectomy
arm group type: Active Comparator
intervention type: Procedure
intervention name: Internal iliac artery ligation
description: Internal iliac artery ligation and cesarean hysterectomy
arm group label: internal iliac artery ligation + cesarean hysterectomy
other name: cesarean hysterectomy
intervention type: Procedure
intervention name: cesarean hysterectomy
description: cesarean hysterectomy
arm group label: cesarean hysterectomy
arm group label: internal iliac artery ligation + cesarean hysterectomy
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed S Sweed, MD
investigator title: Principal Investigator
mesh term: Hemorrhage
sharing ipd: No