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<docDscr>
  <citation>
    <titlStmt>
      <titl>Rhône Alpes birth defects registry</titl>
      <IDNo>FRESH-PEF69-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)" role="">Emmanuelle AMAR</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Rhône Alpes birth defects registry            </titl>
      <altTitl>
                    REMERA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF69-en            </IDNo>
      <IDNo agency="PEF">
                    69                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF69                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Emmanuelle AMAR                                                                                </AuthEnty>
      <AuthEnty affiliation="REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)">
        <ExtLink title="SIREN" URI="494872328" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            REGION AUVERGNE RHONE ALPES                    
                                    </fundAg>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
      <fundAg>
                                            AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="REGISTRE DES MALFORMATIONS EN RHONE ALPES (REMERA)" email="emmanuelle.amar@remera.fr">
                    Emmanuelle;AMAR
                                            <ExtLink title="SIREN" URI="494872328" 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="">
                    prevalence of congenital malformations</keyword>
      <keyword vocab="" vocabURI="">
                    reprotoxic risk factors</keyword>
      <keyword vocab="" vocabURI="">
                    antenatal screening</keyword>
      <keyword vocab="" vocabURI="">
                    eugenic abortions</keyword>
      <keyword vocab="" vocabURI="">
                    perinatality</keyword>
      <keyword vocab="" vocabURI="">
                    database on malformations</keyword>
      <keyword vocab="" vocabURI="">
                    epidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    follow-up</keyword>
      <keyword vocab="" vocabURI="">
                    alert</keyword>
      <keyword vocab="" vocabURI="">
                    teratogens</keyword>
      <keyword vocab="" vocabURI="">
                    genetics</keyword>
      <topcClas vocab="health theme">
                        Gynaecology and obstetrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7de64596-5b0d-4977-8f98-b982ff2ec17d"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/284ca20c-beb4-4abe-99fa-ef4513358bad"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006176"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009774"/>
                                                </topcClas>
      <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">
                        Anencephaly or similar anomalies                                            </topcClas>
      <topcClas vocab="cim-11">
                        Structural developmental anomalies of eyelid, lacrimal apparatus or orbit                                            </topcClas>
      <topcClas vocab="cim-11">
                        Structural developmental anomaly of heart or great vessels                                            </topcClas>
      <topcClas vocab="cim-11">
                        Structural developmental anomalies of the nose or cavum                                            </topcClas>
      <topcClas vocab="cim-11">
                        Developmental anomalies                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </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">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental 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>
    </subject>
    <abstract contentType="purpose">Objectives in terms of public health: 1) Evaluation of the importance of the change in malformations (incidence, factors, appearance of a new malformation or of a new malformation symptom, space-time variations of these incidences) 2) Evaluation of the actions in public health: measure the impact of the actions implemented, especially perinatal screening and also the primary prevention initiatives on the prevalence of malformations and propose orientations for the development of health programs. 3) Alert in the case where a link with a teratogen, whether or not known, is suspected In terms of research: 1) Highlight the factors of risk of malformation 2) Study their interactions with susceptibilities of a genetic nature</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1973-01-01"/>
      <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="sex" clusion="I">Other                                                    </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">The following are included in the registry: Congenital malformations diagnosed antenatally or postnatally until the end of the first year of life.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Anthropometry</dataKind>
    </sumDscr>
  </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>&gt;= 20000 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Morbidity registry                    </notes>
    <anlyInfo>
      <respRate>61 000 (in 2012)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
      <complete>Data depersonalized</complete>
    </setAvail>
    <useStmt>
      <conditions>Access to the data (depersonalized) is possible, on request</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Free access</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
