<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/NCT04422067</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0295</org_study_id>
    <nct_id>NCT04422067</nct_id>
  </id_info>
  <brief_title>Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia</brief_title>
  <official_title>Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which&#xD;
      can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be&#xD;
      present at birth. After birth, the diagnosis of retrognathia is based on the clinical&#xD;
      examination. Cephalometry can be used to complete the diagnosis. Several authors have&#xD;
      proposed the use of objective quantitative ultrasound parameters for the antenatal screening&#xD;
      of PRS. In our study, the investigators evaluated fetal cephalometry.&#xD;
&#xD;
      The aim First, the investigators studied the inter- and intra-observer reproducibility of&#xD;
      cephalometry. Second, the investigators established reference values for antenatal&#xD;
      cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance&#xD;
      of cephalometry and the other angles described in the literature for the diagnosis of&#xD;
      retrognathia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility of cephalometry</measure>
    <time_frame>During ultrasound</time_frame>
    <description>Reproducibility of cephalometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perfomance of several angle to diagnose retrognatism</measure>
    <time_frame>During ultrasound</time_frame>
    <description>Perfomance of several angle to diagnose retrognatism</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Pierre Robin Sequence</condition>
  <arm_group>
    <arm_group_label>Case group (Retrognatism)</arm_group_label>
    <description>All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>47 pregnant patients with fetus without facial abnormalities</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fetal cephalometry</intervention_name>
    <description>Fetal cephalometry</description>
    <arm_group_label>Case group (Retrognatism)</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant patients with one or more fetuses suffering from a microretrognathia,&#xD;
        diagnosed prenatally and integrated into a Pierre Robin Sequence&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Pregnant patient (Aged &gt;18years old)&#xD;
&#xD;
          -  with one or more fetuses suffering from a microretrognathia&#xD;
&#xD;
          -  diagnosed prenatally&#xD;
&#xD;
          -  integrated into a Pierre Robin Sequence&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Uncvertain diagnosis&#xD;
&#xD;
          -  Absence of 3D rendering volume&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florent FUCHS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>with one or more fetuses suffering from a microretrognathia</keyword>
  <keyword>Cephalometry</keyword>
  <keyword>Prenatal Diagnosis</keyword>
  <keyword>Facial angles</keyword>
  <keyword>Fetal echography</keyword>
  <keyword>Microretrognathia</keyword>
  <keyword>diagnosed prenatally</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pierre Robin Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04422067
org study id: RECHMPL20_0295
nct id: NCT04422067
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which
      can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be
      present at birth. After birth, the diagnosis of retrognathia is based on the clinical
      examination. Cephalometry can be used to complete the diagnosis. Several authors have
      proposed the use of objective quantitative ultrasound parameters for the antenatal screening
      of PRS. In our study, the investigators evaluated fetal cephalometry.

      The aim First, the investigators studied the inter- and intra-observer reproducibility of
      cephalometry. Second, the investigators established reference values for antenatal
      cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance
      of cephalometry and the other angles described in the literature for the diagnosis of
      retrognathia.
observational model: Case-Control
time perspective: Retrospective
measure: Reproducibility of cephalometry
time frame: During ultrasound
description: Reproducibility of cephalometry
measure: Perfomance of several angle to diagnose retrognatism
time frame: During ultrasound
description: Perfomance of several angle to diagnose retrognatism
arm group label: Case group (Retrognatism)
description: All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases.
arm group label: Control group
description: 47 pregnant patients with fetus without facial abnormalities
intervention type: Other
intervention name: Fetal cephalometry
description: Fetal cephalometry
arm group label: Case group (Retrognatism)
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Florent FUCHS, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Pierre Robin Syndrome
sharing ipd: Undecided
ipd description: NC