<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/NCT01724281</url>
  </required_header>
  <id_info>
    <org_study_id>0059-12</org_study_id>
    <nct_id>NCT01724281</nct_id>
  </id_info>
  <brief_title>Outcome of Babies With Asymetry of Lateral Brain Ventricles</brief_title>
  <official_title>Outcome of Babies With Asymetry of Lateral Brain Ventricles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd&#xD;
      trimester of normal width and asymetry of lateral brain ventricles&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the&#xD;
      fetus would be diagnosed with lateral ventricles that are normal width (&lt;10 m&quot;m) but&#xD;
      discrepacy of &gt;3 m&quot;m will be followed up after delivery by head ultrasound and neurologic&#xD;
      exam&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lateral ventricles width after delivery</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurologic examination of babies with discrepant but normal lateral ventricles</measure>
    <time_frame>2 years</time_frame>
    <description>After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Lateral Ventricles of Fetuses at Mid Trimester</condition>
  <arm_group>
    <arm_group_label>pregnant women between 19-30 weeks gestational age</arm_group_label>
    <description>No intervention, only follow up</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, only follow up</intervention_name>
    <arm_group_label>pregnant women between 19-30 weeks gestational age</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      not relevant&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        women at 19-30 weeks who attend ultrasound exam and diagnosed with asymetry of lateral&#xD;
        brain ventricles.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral&#xD;
             ventricles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lateral ventricles &gt;10 m&quot;m&#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>
  <overall_contact>
    <last_name>Alon Shrim, MD</last_name>
    <phone>+972506246988</phone>
    <email>alon.shrim@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38101</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Alon Shrim, MD</last_name>
      <phone>+972506246988</phone>
      <email>alon.shrim@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Alon Shrim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lateral ventricles</keyword>
  <keyword>Asymetry</keyword>
  <!-- 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/NCT01724281
org study id: 0059-12
nct id: NCT01724281
lead sponsor: 
has dmc: No
The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd
      trimester of normal width and asymetry of lateral brain ventricles
Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the
      fetus would be diagnosed with lateral ventricles that are normal width (<10 m"m) but
      discrepacy of >3 m"m will be followed up after delivery by head ultrasound and neurologic
      exam
observational model: Cohort
time perspective: Prospective
measure: Lateral ventricles width after delivery
time frame: 2 years
description: The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles
measure: Neurologic examination of babies with discrepant but normal lateral ventricles
time frame: 2 years
description: After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles
arm group label: pregnant women between 19-30 weeks gestational age
description: No intervention, only follow up
intervention type: Other
intervention name: No intervention, only follow up
arm group label: pregnant women between 19-30 weeks gestational age
not relevant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alon Shrim, MD
phone: +972506246988
email: alon.shrim@gmail.com
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor