<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF231-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Ile de la Réunion Congenital anomalies register</titl>
      <IDNo>FRESH-PEF231-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" role="">Hanitra RANDRIANAIVO</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Ile de la Réunion Congenital anomalies register            </titl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF231-en            </IDNo>
      <IDNo agency="PEF">
                    231                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF231                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Bénédicte NATIVEL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION">
        <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
        <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Hanitra RANDRIANAIVO                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION">
        <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
        <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            SANTE PUBLIQUE FRANCE                    
                                    </producer>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION                    
                                    </producer>
      <producer role="sponsor">
                    
                                    </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="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" email="benedicte.bertaut-nativel@chu-reunion.fr">
                    Bénédicte;NATIVEL
                                            <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" email="hanitra.randrianaivo@chu-reunion.fr">
                    Hanitra;RANDRIANAIVO
                                            <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    congenital abnormalities</keyword>
      <keyword vocab="" vocabURI="">
                    prenatal diagnosis</keyword>
      <keyword vocab="" vocabURI="">
                    alert</keyword>
      <keyword vocab="" vocabURI="">
                    toxic risk factors to reproduction</keyword>
      <keyword vocab="" vocabURI="">
                    teratogens</keyword>
      <keyword vocab="" vocabURI="">
                    genetics</keyword>
      <keyword vocab="" vocabURI="">
                    database</keyword>
      <keyword vocab="" vocabURI="">
                    epidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    surveillance</keyword>
      <topcClas vocab="cim-11">
                        Certain infectious or parasitic diseases                                            </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: 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">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">1. Carry out epidemiological surveillance of congenital abnormalities in the population of Reunion Island (determination of prevalence and distribution) and identification of malformation risk factors (genetic, environmental, related to drugs or toxins); with the purpose of sounding the alert when any environmental teratogenic agents become evident (e.g. drug, pesticide exposure, industrial accident) at local, national and international level. Should clusters of malformations be detected (surveillance-alert of an increase in prevalence over time of a given malformation), checks must be made regarding recording bias before conducting further investigations. Then specific risk factors will be sought. 2. Evaluate the impact of public health initiatives in the population: - Evaluation of prenatal screening of malformations is a fundamental objective for the registry, with participation in the field of perinatal medicine and local obstetric practices - Implementation and evaluation of prevention initiatives are also important, such as the primary prevention of neural tube closing defects via folic acid supplements before conception. 2. Identification of possible new syndromes and supply of new information for genetic counseling of families. e-transmission method, genetic heterogeneity, genetic susceptibility factor.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2002-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>La Réunion</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </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">The Registry lists cases of malformation and chromosomal abnormality among living births, still births (from 22 weeks of amenorrhea or more), which are diagnosed within or at one year, as well as therapeutic abortions irrespective of the gestational age. The following are included in the registry:  Congenital malformations diagnosed before or after the birth - up until the end of the infant's first year of life.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>ICD10 for malformations and diseases</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>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
                                    
                                    
                                                                    </sourceCitation>
          <srcOrig>Medico-administrative database</srcOrig>
        </sources>
      </sources>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Morbidity registry                    </notes>
    <anlyInfo>
      <respRate>2002-2009: 3046 cas (source EUROCAT)2009 : 419 cas (source EUROCAT)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Access to individual (anonymized) data possible by request.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Free access</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
