<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/NCT03295123</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A00330-53</org_study_id>
    <nct_id>NCT03295123</nct_id>
  </id_info>
  <brief_title>Outcome of Children Born After Pregnancy Denial</brief_title>
  <acronym>DENIGRO</acronym>
  <official_title>Outcome Children Born After Pregnancy Denial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The objective of this study is to evaluate the impact of denial pregnancy on children's&#xD;
      health ( anthropometric data, psychomotor development , disease) at different age of&#xD;
      evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).&#xD;
&#xD;
      The hypothesis is the denial of pregnancy may have repercussions on children's outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>height (cm)</measure>
    <time_frame>birth</time_frame>
    <description>infants height will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>height (cm)</measure>
    <time_frame>9 months</time_frame>
    <description>infants height will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>height (cm)</measure>
    <time_frame>24 months</time_frame>
    <description>infants height will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>height (cm)</measure>
    <time_frame>between 2 and 5 years</time_frame>
    <description>infants height will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight (kg)</measure>
    <time_frame>birth</time_frame>
    <description>infants weight will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight (kg)</measure>
    <time_frame>9 months</time_frame>
    <description>infants weight will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight (kg)</measure>
    <time_frame>24 months</time_frame>
    <description>infants weight will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight (kg)</measure>
    <time_frame>between 2 and 5 years</time_frame>
    <description>infants weight will be recorded from their health booklet and compared to reference chart log</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>psychomotor development</measure>
    <time_frame>birth</time_frame>
    <description>infants psychomotor development items will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychomotor development</measure>
    <time_frame>9 months</time_frame>
    <description>infants psychomotor development items will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychomotor development</measure>
    <time_frame>24 months</time_frame>
    <description>infants psychomotor development items will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychomotor development</measure>
    <time_frame>between 2 and 5 years</time_frame>
    <description>infants psychomotor development items will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease</measure>
    <time_frame>birth</time_frame>
    <description>all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease</measure>
    <time_frame>9 months</time_frame>
    <description>all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease</measure>
    <time_frame>24 months</time_frame>
    <description>all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease</measure>
    <time_frame>between 2 and 5 years</time_frame>
    <description>all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log</description>
  </secondary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Child Development</condition>
  <condition>Denial (Psychology)</condition>
  <condition>Disease</condition>
  <condition>Personality Development</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone interview with the mother</intervention_name>
    <description>it's a telephone survey about children's health</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every children born at term after denial of pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child born after denial of pregnancy&#xD;
&#xD;
          -  Child born at term ( &gt; 37 weeks of gestation)&#xD;
&#xD;
          -  Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de&#xD;
             Nancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mother's opposition&#xD;
&#xD;
          -  Child doesn't' living in France&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>8 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Maternity Hospital CHRU</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Jean-Michel HASCOET</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03295123
org study id: 2017-A00330-53
nct id: NCT03295123
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the impact of denial pregnancy on children's
      health ( anthropometric data, psychomotor development , disease) at different age of
      evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).

      The hypothesis is the denial of pregnancy may have repercussions on children's outcome.
observational model: Case-Only
time perspective: Prospective
measure: height (cm)
time frame: birth
description: infants height will be recorded from their health booklet and compared to reference chart log
measure: height (cm)
time frame: 9 months
description: infants height will be recorded from their health booklet and compared to reference chart log
measure: height (cm)
time frame: 24 months
description: infants height will be recorded from their health booklet and compared to reference chart log
measure: height (cm)
time frame: between 2 and 5 years
description: infants height will be recorded from their health booklet and compared to reference chart log
measure: weight (kg)
time frame: birth
description: infants weight will be recorded from their health booklet and compared to reference chart log
measure: weight (kg)
time frame: 9 months
description: infants weight will be recorded from their health booklet and compared to reference chart log
measure: weight (kg)
time frame: 24 months
description: infants weight will be recorded from their health booklet and compared to reference chart log
measure: weight (kg)
time frame: between 2 and 5 years
description: infants weight will be recorded from their health booklet and compared to reference chart log
measure: psychomotor development
time frame: birth
description: infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
measure: psychomotor development
time frame: 9 months
description: infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
measure: psychomotor development
time frame: 24 months
description: infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
measure: psychomotor development
time frame: between 2 and 5 years
description: infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
measure: disease
time frame: birth
description: all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
measure: disease
time frame: 9 months
description: all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
measure: disease
time frame: 24 months
description: all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
measure: disease
time frame: between 2 and 5 years
description: all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
intervention type: Other
intervention name: phone interview with the mother
description: it's a telephone survey about children's health
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 8 Years
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Jean-Michel HASCOET
investigator title: Professor