<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/NCT03750266</url>
  </required_header>
  <id_info>
    <org_study_id>STH19783</org_study_id>
    <nct_id>NCT03750266</nct_id>
  </id_info>
  <brief_title>3D Animation and Models to Aid Management of Fetal CDH</brief_title>
  <official_title>The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We wish to use the images a mother would have done as part of her normal medical care and&#xD;
      make both 3D animations and 3D models of the baby and it's CDH. This will both help the&#xD;
      parents see what the problem is and also allow the surgeons, who will operate on the baby&#xD;
      once it has been born, to see the size of the hole and what organs are in the wrong place.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Patient demographics</measure>
    <time_frame>Baseline</time_frame>
    <description>Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Congenital Diaphragmatic Hernia</condition>
  <arm_group>
    <arm_group_label>Congenital Diaphragmatic Hernia referred for fetal MRA</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention data collected through routine scans</intervention_name>
    <description>No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.</description>
    <arm_group_label>Congenital Diaphragmatic Hernia referred for fetal MRA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are&#xD;
        referred to MRI and agree to take part in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.&#xD;
&#xD;
          -  Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose&#xD;
             fetus had a CDH and are referred to MRI.&#xD;
&#xD;
          -  Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose&#xD;
             fetus had a CDH and are referred to MRI and agree to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to give informed consent due to any reason including poor understanding of&#xD;
             English&#xD;
&#xD;
          -  Under 18 years of age.&#xD;
&#xD;
          -  Unable to complete the fetal MRI process due to either metal implants or&#xD;
             claustrophobia.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women whose fetus had a CDH and are referred to MRI.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jessop Wing Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elspeth Whitby</last_name>
      <phone>0114 2261081</phone>
      <email>e.whitby@sheffield.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>June 20, 2022</last_update_submitted>
  <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</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>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</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/NCT03750266
org study id: STH19783
nct id: NCT03750266
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We wish to use the images a mother would have done as part of her normal medical care and
      make both 3D animations and 3D models of the baby and it's CDH. This will both help the
      parents see what the problem is and also allow the surgeons, who will operate on the baby
      once it has been born, to see the size of the hole and what organs are in the wrong place.
observational model: Cohort
time perspective: Prospective
measure: Patient demographics
time frame: Baseline
description: Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed.
arm group label: Congenital Diaphragmatic Hernia referred for fetal MRA
intervention type: Other
intervention name: No intervention data collected through routine scans
description: No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.
arm group label: Congenital Diaphragmatic Hernia referred for fetal MRA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women whose fetus had a CDH and are referred to MRI.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Hernia
mesh term: Hernia, Diaphragmatic
sharing ipd: No