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/NCT05989178</url>
    </required_header>
    <id_info>
      <org_study_id>H21-01887</org_study_id>
      <nct_id>NCT05989178</nct_id>
    </id_info>
    <brief_title>Prospective Recurrent Pregnancy Loss Registry</brief_title>
    <official_title>Prospective Recurrent Pregnancy Loss (ProRPL) Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of British Columbia</source>
    <brief_summary>
      <textblock>
        The purpose of this Registry is to prospectively collect data of Recurrent Pregnancy Loss&#xD;
        (RPL) patients attending the specialized care centre at the BC Women's Hospital, in order to&#xD;
        evaluate investigation practices, treatment options, and outcomes for this patient population&#xD;
        over time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Recurrent Pregnancy Loss Program at the BC Women's Centre for Reproductive Health is the&#xD;
        only tertiary care centre of its kind in British Columbia, and has provided specialized and&#xD;
        comprehensive care to RPL patients for the past 15 years. Using a team-based collaborative&#xD;
        model, the program provides point-of-care investigations, surgical treatment, clinical&#xD;
        management, education, and grief counselling.&#xD;
  &#xD;
        All RPL patients are asked to complete the intake questionnaire prior to their initial visit&#xD;
        at the clinic. If the patient provides their consent to take part in research, their data&#xD;
        will be copied from the clinical database to the research database. The questionnaire&#xD;
        includes information regarding patient demographics, obstetric history, gynecological&#xD;
        history, personal and medical history, family history and partner information. Additionally,&#xD;
        data will also be collected from patient charts, follow-up questionnaires sent once a year&#xD;
        for the next 5 years following the patient's initial visit, and medical records from&#xD;
        fertility clinics and general practitioners when available.&#xD;
  &#xD;
        The online data registry is housed in the Research Electronic Data Capture (REDCap) platform&#xD;
        located at BC Children's Hospital (BCCH).&#xD;
  &#xD;
        As an optional component of this study, patients invited to join the registry will also be&#xD;
        presented with the option to register with the BCCH BioBank to store their tissue samples&#xD;
        collected in the RPL clinic for clinical &amp; diagnostic purposes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2032</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2032</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>Live Birth</measure>
      <time_frame>5 years</time_frame>
      <description>Percent of patients with a live birth within 5 years after initial visit at the clinic.</description>
    </primary_outcome>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Recurrent Pregnancy Loss</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Data Registry</intervention_name>
      <description>Follow-up questionnaires sent every year for the 5 years following the patient's initial visit.</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Products of conception (optional)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients at the BC Women's Recurrent Pregnancy Loss Clinic seen for recurrent pregnancy&#xD;
          loss.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • All new and re-referred patients at the BC Women's Recurrent Pregnancy Loss Clinic with&#xD;
          recurrent pregnancy loss, defined as ≥2 miscarriages or ≥1 miscarriage beyond 10 weeks&#xD;
          gestation; therapeutic abortions, ectopic pregnancies, and molar pregnancies are excluded&#xD;
          from the miscarriage count.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Patients at BC Women's Recurrent Pregnancy Loss Clinic seen for reasons other than&#xD;
          recurrent pregnancy loss.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mohamed A. Bedaiwy, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>BC Women's Hospital &amp; Health Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed A. Bedaiwy, MD, PhD</last_name>
      <phone>604-875-2000</phone>
      <phone_ext>4310</phone_ext>
      <email>mohamed.bedaiwy@cw.bc.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>BC Women's Hospital &amp; Health Centre</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V6H 3N1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed A. Bedaiwy, MD, PhD</last_name>
        <phone>604-875-2000</phone>
        <phone_ext>4310</phone_ext>
        <email>mohamed.bedaiwy@cw.bc.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Mohamed Bedaiwy</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Recurrent pregnancy loss</keyword>
    <keyword>Unexplained</keyword>
    <keyword>Explained</keyword>
    <keyword>Miscarriage</keyword>
    <keyword>Live Birth</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abortion, Spontaneous</mesh_term>
      <mesh_term>Fetal Death</mesh_term>
      <mesh_term>Abortion, Habitual</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05989178
  org study id: H21-01887
  nct id: NCT05989178
  lead sponsor: 
  The purpose of this Registry is to prospectively collect data of Recurrent Pregnancy Loss
        (RPL) patients attending the specialized care centre at the BC Women's Hospital, in order to
        evaluate investigation practices, treatment options, and outcomes for this patient population
        over time.
  The Recurrent Pregnancy Loss Program at the BC Women's Centre for Reproductive Health is the
        only tertiary care centre of its kind in British Columbia, and has provided specialized and
        comprehensive care to RPL patients for the past 15 years. Using a team-based collaborative
        model, the program provides point-of-care investigations, surgical treatment, clinical
        management, education, and grief counselling.
  
        All RPL patients are asked to complete the intake questionnaire prior to their initial visit
        at the clinic. If the patient provides their consent to take part in research, their data
        will be copied from the clinical database to the research database. The questionnaire
        includes information regarding patient demographics, obstetric history, gynecological
        history, personal and medical history, family history and partner information. Additionally,
        data will also be collected from patient charts, follow-up questionnaires sent once a year
        for the next 5 years following the patient's initial visit, and medical records from
        fertility clinics and general practitioners when available.
  
        The online data registry is housed in the Research Electronic Data Capture (REDCap) platform
        located at BC Children's Hospital (BCCH).
  
        As an optional component of this study, patients invited to join the registry will also be
        presented with the option to register with the BCCH BioBank to store their tissue samples
        collected in the RPL clinic for clinical & diagnostic purposes.
  observational model: Cohort
  time perspective: Prospective
  measure: Live Birth
  time frame: 5 years
  description: Percent of patients with a live birth within 5 years after initial visit at the clinic.
  intervention type: Other
  intervention name: Data Registry
  description: Follow-up questionnaires sent every year for the 5 years following the patient's initial visit.
  Products of conception (optional)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 49 Years
  last name: Mohamed A. Bedaiwy, MD, PhD
  role: Principal Investigator
  affiliation: BC Women's Hospital & Health Centre
  last name: Mohamed A. Bedaiwy, MD, PhD
  phone: 604-875-2000
  phone ext: 4310
  email: mohamed.bedaiwy@cw.bc.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Mohamed Bedaiwy
  investigator title: Principal Investigator
  mesh term: Abortion, Spontaneous
  mesh term: Fetal Death
  mesh term: Abortion, Habitual
  mesh term: Recurrence
  sharing ipd: No