<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/NCT02990403</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiFMIH-0003</org_study_id>
    <nct_id>NCT02990403</nct_id>
  </id_info>
  <brief_title>The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss</brief_title>
  <official_title>The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss</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 are going to observe the efficacy of&#xD;
      anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a&#xD;
      prospective randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 22, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2017</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>live birth</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
    <description>live birth means success pregnancy（more than gestational age of 20 weeks）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uterine artery blood flow</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>human chorionic gonadotropin</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Recurrent Pregnancy Loss</condition>
  <arm_group>
    <arm_group_label>aspirin+LMWH group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin+LMWH+immunoglobulin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin+LMWH+prednisone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin+LMWH+IVIG+prednisone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dydrogesterone group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>dydrogesterone 20-30mg/day, po, tid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>aspirin+LMWH group</arm_group_label>
    <arm_group_label>aspirin+LMWH+IVIG+prednisone group</arm_group_label>
    <arm_group_label>aspirin+LMWH+immunoglobulin group</arm_group_label>
    <arm_group_label>aspirin+LMWH+prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <arm_group_label>aspirin+LMWH group</arm_group_label>
    <arm_group_label>aspirin+LMWH+IVIG+prednisone group</arm_group_label>
    <arm_group_label>aspirin+LMWH+immunoglobulin group</arm_group_label>
    <arm_group_label>aspirin+LMWH+prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <arm_group_label>aspirin+LMWH+IVIG+prednisone group</arm_group_label>
    <arm_group_label>aspirin+LMWH+prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunoglobulin</intervention_name>
    <arm_group_label>aspirin+LMWH+IVIG+prednisone group</arm_group_label>
    <arm_group_label>aspirin+LMWH+immunoglobulin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dydrogesterone</intervention_name>
    <arm_group_label>dydrogesterone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Woman who had 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed&#xD;
        as thrombophilia with recurrent pregnancy loss. 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 limb&#xD;
             disabled.&#xD;
&#xD;
          3. taking medicine within one month.&#xD;
&#xD;
          4. suffering major events or having mood swings.&#xD;
&#xD;
          5. 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;
          6. chromosome aberrations in anyone of the couple.&#xD;
&#xD;
          7. patients who have drugs 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>December 2016</verification_date>
  <study_first_submitted>December 7, 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>March 6, 2017</last_update_submitted>
  <last_update_submitted_qc>March 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2017</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>Abortion, Spontaneous</mesh_term>
    <mesh_term>Fetal Death</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Dydrogesterone</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</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/NCT02990403
org study id: ShanghaiFMIH-0003
nct id: NCT02990403
lead sponsor: 
In this clinical cohort study, the investigators are going to observe the efficacy of
      anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a
      prospective randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: live birth
time frame: through study completion, an average of 3 year
description: live birth means success pregnancy（more than gestational age of 20 weeks）
measure: D-dimer
time frame: through study completion, an average of 3 year
measure: Uterine artery blood flow
time frame: through study completion, an average of 3 year
measure: human chorionic gonadotropin
time frame: through study completion, an average of 3 year
arm group label: aspirin+LMWH group
arm group type: Experimental
description: aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
arm group label: aspirin+LMWH+immunoglobulin group
arm group type: Experimental
description: aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
arm group label: aspirin+LMWH+prednisone group
arm group type: Experimental
description: aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
arm group label: aspirin+LMWH+IVIG+prednisone group
arm group type: Experimental
description: aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
arm group label: dydrogesterone group
arm group type: Other
description: dydrogesterone 20-30mg/day, po, tid
intervention type: Drug
intervention name: Aspirin
arm group label: aspirin+LMWH group
arm group label: aspirin+LMWH+IVIG+prednisone group
arm group label: aspirin+LMWH+immunoglobulin group
arm group label: aspirin+LMWH+prednisone group
intervention type: Drug
intervention name: Heparin
arm group label: aspirin+LMWH group
arm group label: aspirin+LMWH+IVIG+prednisone group
arm group label: aspirin+LMWH+immunoglobulin group
arm group label: aspirin+LMWH+prednisone group
intervention type: Drug
intervention name: Prednisone
arm group label: aspirin+LMWH+IVIG+prednisone group
arm group label: aspirin+LMWH+prednisone group
intervention type: Drug
intervention name: Immunoglobulin
arm group label: aspirin+LMWH+IVIG+prednisone group
arm group label: aspirin+LMWH+immunoglobulin group
intervention type: Drug
intervention name: Dydrogesterone
arm group label: dydrogesterone 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: Abortion, Spontaneous
mesh term: Fetal Death
mesh term: Abortion, Habitual
mesh term: Recurrence
mesh term: Aspirin
mesh term: Prednisone
mesh term: Heparin
mesh term: Dydrogesterone
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies