<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/NCT02193516</url>
  </required_header>
  <id_info>
    <org_study_id>MMC1413-0250CTIL</org_study_id>
    <nct_id>NCT02193516</nct_id>
  </id_info>
  <brief_title>Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <brief_summary>
    <textblock>
      Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can&#xD;
      indicate possible nephropathy. The evolution of CMD across gestation had not been well&#xD;
      established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20&#xD;
      weeks. In our study we would like to determine the exact timing of it's sonographic&#xD;
      visualisation. This is a prospective study recruiting women between 14-24 week gestation&#xD;
      during routine ultrasound screening. A midsagittal image of each kidney will be taken by a&#xD;
      single sonographer and examined for the presence of the CMD by two other sonographers blinded&#xD;
      to gestational age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CMD presence</measure>
    <time_frame>A single exam for each participent. The photos will be reviewed within up to 6 month from examination date</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Nephropathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women 14-24 gestational age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women 14-24 weeks&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  Appropriate for gestational age fetuses&#xD;
&#xD;
          -  well dated pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  family history of renal disease&#xD;
&#xD;
          -  small /large for gestational age fetuses&#xD;
&#xD;
          -  known structural anomalies&#xD;
&#xD;
          -  unknown dating&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Efrat Hadi, MD</last_name>
    <phone>09-7472871</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Hospital</name>
      <address>
        <city>kfar Sava</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Efrat hadi</last_name>
    </contact>
    <investigator>
      <last_name>Efrat Hadi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</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>Kidney Diseases</mesh_term>
  </condition_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/NCT02193516
org study id: MMC1413-0250CTIL
nct id: NCT02193516
lead sponsor: 
Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can
      indicate possible nephropathy. The evolution of CMD across gestation had not been well
      established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20
      weeks. In our study we would like to determine the exact timing of it's sonographic
      visualisation. This is a prospective study recruiting women between 14-24 week gestation
      during routine ultrasound screening. A midsagittal image of each kidney will be taken by a
      single sonographer and examined for the presence of the CMD by two other sonographers blinded
      to gestational age.
observational model: Case-Only
time perspective: Cross-Sectional
measure: CMD presence
time frame: A single exam for each participent. The photos will be reviewed within up to 6 month from examination date
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Efrat Hadi, MD
phone: 09-7472871
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Kidney Diseases