xml: <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/NCT05979181</url>
    </required_header>
    <id_info>
      <org_study_id>R.23.06.2211</org_study_id>
      <nct_id>NCT05979181</nct_id>
    </id_info>
    <brief_title>Peripartum Cesarean Hysterectomy for Placenta Percreta</brief_title>
    <official_title>Peripartum Cesarean Hysterectomy for Placenta Percreta: a Retrospective Analysis of Cases With and Without Extrauterine Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to address the possible preoperative determinants of extrauterine&#xD;
        diseases in cases of placenta previa percreta and to compare the operative and postoperative&#xD;
        characteristics of cases with and without extrauterine disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a retrospective study of the data of women who underwent cesarean hysterectomy&#xD;
        on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics&#xD;
        (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women&#xD;
        with extrauterine disease (FIGO grades 3b and 3c)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 20, 2018</start_date>
    <completion_date type="Actual">February 17, 2023</completion_date>
    <primary_completion_date type="Actual">February 17, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Estimated amount of intraoperative blood loss</measure>
      <time_frame>From start to end of operation</time_frame>
      <description>Calculated amount of blood loss during the operation</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">73</enrollment>
    <condition>Placenta Accreta</condition>
    <arm_group>
      <arm_group_label>No extrauterine disease group</arm_group_label>
      <description>Women having placenta previa percreta with no extrauterine disease (FIGO grade 3a)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Extrauterine disease group</arm_group_label>
      <description>Women having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cesarean hysterectomy</intervention_name>
      <description>Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)</description>
      <arm_group_label>Extrauterine disease group</arm_group_label>
      <arm_group_label>No extrauterine disease group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3)&#xD;
          diagnosed by color flow Doppler, and confirmed intraoperatively&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medical conditions complicating pregnancy.&#xD;
  &#xD;
            -  Blood diseases or bleeding tendencies&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Khaled S Ismail, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mahmoud M Awad, MD</last_name>
      <role>Study Director</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alhussein A Mohamed, MD</last_name>
      <role>Study Director</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed S Abdelhafez, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mansoura University Hospital</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>35111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PAS</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>Placenta Accreta</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979181
  org study id: R.23.06.2211
  nct id: NCT05979181
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to address the possible preoperative determinants of extrauterine
        diseases in cases of placenta previa percreta and to compare the operative and postoperative
        characteristics of cases with and without extrauterine disease.
  This will be a retrospective study of the data of women who underwent cesarean hysterectomy
        on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics
        (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women
        with extrauterine disease (FIGO grades 3b and 3c)
  observational model: Cohort
  time perspective: Retrospective
  measure: Estimated amount of intraoperative blood loss
  time frame: From start to end of operation
  description: Calculated amount of blood loss during the operation
  arm group label: No extrauterine disease group
  description: Women having placenta previa percreta with no extrauterine disease (FIGO grade 3a)
  arm group label: Extrauterine disease group
  description: Women having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c)
  intervention type: Procedure
  intervention name: Cesarean hysterectomy
  description: Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)
  arm group label: Extrauterine disease group
  arm group label: No extrauterine disease group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Khaled S Ismail, MD
  role: Principal Investigator
  affiliation: Mansoura University
  last name: Mahmoud M Awad, MD
  role: Study Director
  affiliation: Mansoura University
  last name: Alhussein A Mohamed, MD
  role: Study Director
  affiliation: Mansoura University
  last name: Mohamed S Abdelhafez, MD
  role: Study Chair
  affiliation: Mansoura University
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Placenta Accreta