<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/NCT02990390</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiFMIH-0001</org_study_id>
    <nct_id>NCT02990390</nct_id>
  </id_info>
  <brief_title>The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla</brief_title>
  <official_title>Shanghai First Maternity and Infant Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai First Maternity and Infant Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune&#xD;
      disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections.&#xD;
      However, the underlying causes remain undetermined in up to 50% of cases. In this clinical&#xD;
      cohort study, we intended to get an epidemiological evidence for patients with recurrent&#xD;
      spontaneous abortion associated with thrombophilla.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>D-Dimer</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI in kg/m^2</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>platelet aggregation time</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anticardiolipin antibody</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">45000</enrollment>
  <condition>Recurrent Pregnancy Loss</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Woman who had their Second miscarriage before 12(th) week of gestation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. having experienced severe allergies, trauma history and/or operation history within 3&#xD;
             months;&#xD;
&#xD;
          2. with a history of mental illness and/or family history of mental illness&#xD;
&#xD;
          3. limb disabled&#xD;
&#xD;
          4. taking medicine within one month&#xD;
&#xD;
          5. suffering major events or having mood swings&#xD;
&#xD;
          6. with a history of recurrent pregnancy loss&#xD;
&#xD;
          7. having internal and surgical disease(after having variety of physical examination such&#xD;
             as electrocardiogram/hepatic and renal function/blood routine and urine routine)&#xD;
&#xD;
          8. chromosome aberrations in anyone of the couple.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai first Maternity and Infant health hospital, Tong Ji University</name>
      <address>
        <city>Shanghai</city>
        <zip>200051</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shihua Bao, PhD</last_name>
      <phone>86-21-20261430</phone>
      <phone_ext>2012</phone_ext>
      <email>baoshihua@tongji.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yan Yan, Master</last_name>
      <phone>86-21-20261430</phone>
      <phone_ext>2012</phone_ext>
      <email>shtjyanyan@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Shihua Chen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yan Yan, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai First Maternity and Infant Hospital</investigator_affiliation>
    <investigator_full_name>Shihua Bao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02990390
org study id: ShanghaiFMIH-0001
nct id: NCT02990390
lead sponsor: 
has dmc: Yes
RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune
      disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections.
      However, the underlying causes remain undetermined in up to 50% of cases. In this clinical
      cohort study, we intended to get an epidemiological evidence for patients with recurrent
      spontaneous abortion associated with thrombophilla.
observational model: Cohort
measure: D-Dimer
time frame: through study completion, an average of 3 year
measure: BMI in kg/m^2
time frame: through study completion, an average of 3 year
measure: platelet aggregation time
time frame: through study completion, an average of 3 year
measure: anticardiolipin antibody
time frame: through study completion, an average of 3 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai First Maternity and Infant Hospital
investigator full name: Shihua Bao
investigator title: Principal Investigator
mesh term: Recurrence
sharing ipd: Undecided