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<docDscr>
  <citation>
    <titlStmt>
      <titl>Registry of Congenital Malformations in Auvergne (Certified Registry 2012-2015)</titl>
      <IDNo>FRESH-PEF230-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTR ETUDE MALFORM CONGEN REGION AUVERG (CEMC AUVERGNE)" role="">Isabelle PERTHUS</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Registry of Congenital Malformations in Auvergne (Certified Registry 2012-2015)            </titl>
      <altTitl>
                    CEMC-Auvergne                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF230-en            </IDNo>
      <IDNo agency="PEF">
                    230                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF230                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Isabelle PERTHUS                                                                                </AuthEnty>
      <AuthEnty affiliation="CENTR ETUDE MALFORM CONGEN REGION AUVERG (CEMC AUVERGNE)">
        <ExtLink title="SIREN" URI="419442231" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
      <fundAg>
                                            SANTE PUBLIQUE FRANCE                    
                                    </fundAg>
      <fundAg>
                                            AGENCE REGIONALE DE SANTE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTR ETUDE MALFORM CONGEN REGION AUVERG (CEMC AUVERGNE)" email="iperthus@chu-clermontferrand.fr">
                    Isabelle;PERTHUS
                                            <ExtLink title="SIREN" URI="419442231" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    prenatal diagnosis</keyword>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Developmental anomalies                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The registry's primary objective is to conduct epidemiological surveillance of congenital malformations in Auvergne, with a role of sounding the alert when any environmental teratogenic agents become evident. With the development of prevention measures - particularly in the field of prenatal diagnosis - this surveillance-alert mission has gradually been extended to include an essential role in evaluating the impact of public health policies with regards to perinatal care on the population. The registry also helps to improve knowledge in the field of malformations by collaborating on studies with specialist clinical departments (particularly genetic and foetal medicine departments) and by being involved in the Multidisciplinary Center for Prenatal Diagnosis in Clermont- Ferrand (the registry's data provides food for thought from obstetricians on the meaning and action to take when certain malformations are observed during prenatal diagnosis). Lastly, the registry's data informs healthcare stakeholders and the public authorities about congenital malformations and chromosomal abnormalities.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1983-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Auvergne Rhône-Alpes</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">People with disabilities                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe clusion="I">All malformed children are listed, whether stillborn or a live birth after a pregnancy of at least 22 weeks of amenorrhoea, or in the event of therapeutic abortion due to foetal malformation, regardless of term. For children who are born alive, the malformation diagnosis must have been made before the end of their first year of life (infants may be recorded up to 12 months after their birth). All types of malformation are included, whether these concern isolated or polymalformative syndromes, whether or not identified, with normal or abnormal karyotype.                     </universe>
      <universe clusion="E">are inborn metabolic errors and minor malformations or deformations (snapping hips without real dislocation, deformed feet, small superficial naevi or angiomas less than 4cm2, inguinal hernia, umbilical hernia not requiring surgery, isolated persistent ductus arteriosus in premature infants weighing less than 2.5kg, hypertrophic pyloric stenosis, single umbilical artery, uni- or bilateral ectopic testis).                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>ICD 10</standardName>
          <standardName>ATC.</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>[10000-20000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Morbidity registry                    </notes>
    <anlyInfo>
      <respRate>10 145 patients (1983-2011)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>By request to the scientist in charge.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
</dataDscr></codeBook>
