<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/NCT02982356</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiFMIH-FMU2</org_study_id>
    <nct_id>NCT02982356</nct_id>
  </id_info>
  <brief_title>Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy</brief_title>
  <official_title>Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Peace Maternity and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai First Maternity and Infant Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The risk of abnormal chromosome and structure is much higher in twins than in singletons, and&#xD;
      traditional early pregnancy screening strategy for single pregnancy is not suitable for&#xD;
      twins. Based on our management experience of fetal medicine at twin pregnancy, and&#xD;
      multi-center cooperation, the study will carry out the following clinical studies:&#xD;
&#xD;
        1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for&#xD;
           twin pregnancy.&#xD;
&#xD;
        2. fetal chromosomal abnormalities&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate for the operation</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>long-term complications after surgery</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Chromosome Abnormality</condition>
  <condition>Twin Pregnancy With Antenatal Problem</condition>
  <arm_group>
    <arm_group_label>Fetal Selective Reduction Technology</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>normal dichorial twins without any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fetal Selective Reduction Technology</intervention_name>
    <description>Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,&gt;28weeks</description>
    <arm_group_label>Fetal Selective Reduction Technology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium Chloride</intervention_name>
    <arm_group_label>Fetal Selective Reduction Technology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ultrasound diagnosis as twin pregnancy&#xD;
&#xD;
          -  at 11-14 gestational weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancies (three or more)&#xD;
&#xD;
          -  Maternal history of chromosome aneuploidy abnormality or tumor&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromosome Disorders</mesh_term>
    <mesh_term>Chromosome Aberrations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The Individual Participant Data sharing plan will be discussed with the other collaborators</ipd_description>
  </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/NCT02982356
org study id: ShanghaiFMIH-FMU2
nct id: NCT02982356
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The risk of abnormal chromosome and structure is much higher in twins than in singletons, and
      traditional early pregnancy screening strategy for single pregnancy is not suitable for
      twins. Based on our management experience of fetal medicine at twin pregnancy, and
      multi-center cooperation, the study will carry out the following clinical studies:

        1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for
           twin pregnancy.

        2. fetal chromosomal abnormalities
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success rate for the operation
time frame: 1 week
measure: long-term complications after surgery
time frame: 1 year
arm group label: Fetal Selective Reduction Technology
arm group type: Other
description: Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure
arm group label: control group
arm group type: No Intervention
description: normal dichorial twins without any intervention
intervention type: Procedure
intervention name: Fetal Selective Reduction Technology
description: Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks
arm group label: Fetal Selective Reduction Technology
intervention type: Drug
intervention name: Potassium Chloride
arm group label: Fetal Selective Reduction Technology
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Chromosome Disorders
mesh term: Chromosome Aberrations
sharing ipd: Undecided
ipd description: The Individual Participant Data sharing plan will be discussed with the other collaborators