<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/NCT03303768</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0477</org_study_id>
    <nct_id>NCT03303768</nct_id>
  </id_info>
  <brief_title>Antenatal Diagnosis of Coarctations of the Aorta.</brief_title>
  <acronym>CoA</acronym>
  <official_title>Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the&#xD;
      isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero&#xD;
      diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try&#xD;
      to establish the diagnosis since it has been shown that the prenatal diagnosis improves&#xD;
      survival and reduces morbidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 29, 2018</completion_date>
  <primary_completion_date type="Actual">August 29, 2018</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>Search for ultrasound risk factors associated with diagnosis coarctation of the aorta</measure>
    <time_frame>24h after birth</time_frame>
    <description>Calculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Coarctation of Aorta</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last&#xD;
        12 for suspected coarctation of the aorta isolated during pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant or having given birth in the last 12 months in one of the participating&#xD;
             centers&#xD;
&#xD;
          -  have had an ultrasound screening in the 2nd or 3rd trimester&#xD;
&#xD;
          -  addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis&#xD;
             for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the&#xD;
             aegis of the left ventricle or the large vessels at the aorta, discovered during a&#xD;
             screening ultrasound second or third quarter.&#xD;
&#xD;
          -  be able to understand and follow the ins and outs of the study&#xD;
&#xD;
          -  Have been informed of the study and have not objected to it&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated complex cardiac disease (transposition of large vessels, atrioventricular&#xD;
             duct, right ventricle with double outlet) with the exception of inter ventricular&#xD;
             communications&#xD;
&#xD;
          -  Left ventricular hypoplasia&#xD;
&#xD;
          -  Suspicion of interruption of the aortic arch&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</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>Aortic Coarctation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03303768
org study id: 69HCL17_0477
nct id: NCT03303768
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the
      isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero
      diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try
      to establish the diagnosis since it has been shown that the prenatal diagnosis improves
      survival and reduces morbidity.
observational model: Cohort
time perspective: Prospective
measure: Search for ultrasound risk factors associated with diagnosis coarctation of the aorta
time frame: 24h after birth
description: Calculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta.
arm group label: Pregnant women
description: Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy
intervention type: Diagnostic Test
intervention name: Ultrasound
description: Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Aortic Coarctation
sharing ipd: No