<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/NCT01707875</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-0062-12-CTIL</org_study_id>
    <nct_id>NCT01707875</nct_id>
  </id_info>
  <brief_title>Fetal Brain Asymmetry: in Utero and Early Neonatal Follow up</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fetal brain asymmetry is considered a normal developmental processes. The size and shape of&#xD;
      the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of&#xD;
      the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle&#xD;
      measurement is one of the most frequently used sonographic tool for the evaluation of brain&#xD;
      development. It is easier to evaluate and measure the distal cerebral ventricle, and&#xD;
      therefore data concerning the normal range of asymmetry and the normal progress of the&#xD;
      asymmetry are limited.&#xD;
&#xD;
      The objective of the study is to follow up the incidental finding of fetal ventricle brain&#xD;
      asymmetry between 19-30 weeks of pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulties in recruiting&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Fetal Ventricle Brain Asymmetry</condition>
  <arm_group>
    <arm_group_label>fetal ventricle brain asymmetry</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fetal brain neurosonography</intervention_name>
    <description>fetal brain neurosonography according to the ISUG guidelines</description>
    <arm_group_label>fetal ventricle brain asymmetry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with fetal ventricle brain asymmetry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-42 years old pregnant women&#xD;
&#xD;
          -  19-30 weeks of pregnancy&#xD;
&#xD;
          -  No medical history of chronic disease&#xD;
&#xD;
          -  No medical history of drug therapy&#xD;
&#xD;
          -  No other findings on ultrasound examination&#xD;
&#xD;
          -  Low risk pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fetal malformation&#xD;
&#xD;
          -  Chronic maternal disease&#xD;
&#xD;
          -  Fetal chromosomal aberration&#xD;
&#xD;
          -  suspected fetal infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>June 14, 2015</last_update_submitted>
  <last_update_submitted_qc>June 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01707875
org study id: EMC-0062-12-CTIL
nct id: NCT01707875
lead sponsor: 
has dmc: No
Fetal brain asymmetry is considered a normal developmental processes. The size and shape of
      the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of
      the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle
      measurement is one of the most frequently used sonographic tool for the evaluation of brain
      development. It is easier to evaluate and measure the distal cerebral ventricle, and
      therefore data concerning the normal range of asymmetry and the normal progress of the
      asymmetry are limited.

      The objective of the study is to follow up the incidental finding of fetal ventricle brain
      asymmetry between 19-30 weeks of pregnancy.
observational model: Case-Only
time perspective: Prospective
arm group label: fetal ventricle brain asymmetry
intervention type: Other
intervention name: fetal brain neurosonography
description: fetal brain neurosonography according to the ISUG guidelines
arm group label: fetal ventricle brain asymmetry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
responsible party type: Sponsor