<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/NCT02986594</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiFIMH-0002</org_study_id>
    <nct_id>NCT02986594</nct_id>
  </id_info>
  <brief_title>Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla</brief_title>
  <official_title>Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine</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>
  <brief_summary>
    <textblock>
      In this clinical cohort study, the investigators observe the efficacy of low molecular weight&#xD;
      heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective&#xD;
      randomized controlled trial.&#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>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Thrombophilia With Recurrent Pregnancy Loss</condition>
  <arm_group>
    <arm_group_label>aspirin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low dose aspirin, 75-100mg, bid, after pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low molecular weight heparin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low molecular weight heparin, 4100u, qd, after pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>aspirin group</arm_group_label>
    <arm_group_label>combination group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <arm_group_label>combination group</arm_group_label>
    <arm_group_label>low molecular weight heparin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman who had their Second miscarriage before 12(th) week of gestation.The patient who&#xD;
             is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. having experiencedsevere 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 rotine)&#xD;
&#xD;
          8. Chromosome aberrations in anyone of the couple.&#xD;
&#xD;
          9. patients who have drug contraindications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</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 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 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>Thrombophilia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Heparin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02986594
org study id: ShanghaiFIMH-0002
nct id: NCT02986594
lead sponsor: 
In this clinical cohort study, the investigators observe the efficacy of low molecular weight
      heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective
      randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
arm group label: aspirin group
arm group type: Experimental
description: low dose aspirin, 75-100mg, bid, after pregnancy
arm group label: low molecular weight heparin group
arm group type: Experimental
description: low molecular weight heparin, 4100u, qd, after pregnancy
arm group label: combination group
arm group type: Experimental
description: low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
intervention type: Drug
intervention name: Aspirin
arm group label: aspirin group
arm group label: combination group
intervention type: Drug
intervention name: Heparin
arm group label: combination group
arm group label: low molecular weight heparin group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
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: Thrombophilia
mesh term: Aspirin
mesh term: Heparin