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/NCT06021964</url>
    </required_header>
    <id_info>
      <org_study_id>2022YFC2704501</org_study_id>
      <nct_id>NCT06021964</nct_id>
    </id_info>
    <brief_title>Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders</brief_title>
    <official_title>Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>TONGJI MEDICAL COLLEGE OF HUST</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>West China Second University Hospital,Sichuan University / West China women's and children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Guangzhou Medical 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The incidence of placenta accreta spectrum disorders has shown an increasing trend worldwide&#xD;
        due to the increase of cesarean section rate. Research on the outcomes of placenta accreta&#xD;
        spectrum disorders primarily relies on retrospective analysis. The aim of this study was to&#xD;
        establish a prospective, multicenter cohort in China in order to conduct further&#xD;
        investigations on the clinical features, predictive capabilities, diagnostic methods, and&#xD;
        pathogenesis of placenta accreta spectrum disorders.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 7, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of placenta accreta spectrum disorders</measure>
      <time_frame>baseline</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preterm delivery Preterm delivery</measure>
      <time_frame>baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lost during delivery</measure>
      <time_frame>baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood loss in the first 24 hours of delivery</measure>
      <time_frame>baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hysterectomy</measure>
      <time_frame>baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood transfusion</measure>
      <time_frame>baseline</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Placenta Accreta Spectrum Disorders,Previous Cesarean Section</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant women aged 18-45 who at least had one previous cesarean section&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women aged 18-45;&#xD;
  &#xD;
            2. at least one previous cesarean section ,regular antenatal examination and plan to give&#xD;
               birth at research center&#xD;
  &#xD;
            3. sign informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Irregular antenatal examination; Twins; Autoimmune diseases; Prepregnancy hypertension;&#xD;
          Prepregnancy diabetes mellitus; Inheritance Sexual diseases; tumor; Abnormal liver and&#xD;
          kidney function in early pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology，The Third Affiliated Hospital of Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <zip>510150</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangzhou Medical University</investigator_affiliation>
      <investigator_full_name>Dunjin Chen</investigator_full_name>
      <investigator_title>Department of Gynecology and Obstetrics, the Third Affiliated Hospital of Guangzhou Medical University</investigator_title>
    </responsible_party>
    <keyword>placenta accreta spectrum disorders；Previous cesarean section</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Placenta Accreta</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06021964
  org study id: 2022YFC2704501
  nct id: NCT06021964
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The incidence of placenta accreta spectrum disorders has shown an increasing trend worldwide
        due to the increase of cesarean section rate. Research on the outcomes of placenta accreta
        spectrum disorders primarily relies on retrospective analysis. The aim of this study was to
        establish a prospective, multicenter cohort in China in order to conduct further
        investigations on the clinical features, predictive capabilities, diagnostic methods, and
        pathogenesis of placenta accreta spectrum disorders.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of placenta accreta spectrum disorders
  time frame: baseline
  measure: Preterm delivery Preterm delivery
  time frame: baseline
  measure: Blood lost during delivery
  time frame: baseline
  measure: Blood loss in the first 24 hours of delivery
  time frame: baseline
  measure: hysterectomy
  time frame: baseline
  measure: Blood transfusion
  time frame: baseline
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Guangzhou Medical University
  investigator full name: Dunjin Chen
  investigator title: Department of Gynecology and Obstetrics, the Third Affiliated Hospital of Guangzhou Medical University
  mesh term: Placenta Accreta
  sharing ipd: Undecided