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<docDscr>
  <citation>
    <titlStmt>
      <titl>Registry of Congenital Malformations in Alsace (Certified Regisrtry)</titl>
      <IDNo>FRESH-PEF62-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)" role="">Danaluiza TIMBOLSCHI</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Registry of Congenital Malformations in Alsace (Certified Regisrtry)            </titl>
      <altTitl>
                    REMACA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF62-en            </IDNo>
      <IDNo agency="PEF">
                    62                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF62                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Danaluiza TIMBOLSCHI                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)">
        <ExtLink title="ROR" URI="https://ror.org/04bckew43" role="organisation id"/>
        <ExtLink title="SIREN" URI="266700574" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            UNIVERSITE DE STRASBOURG                    
                                    </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>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="LES HOPITAUX UNIVERSITAIRES DE STRASBOURG (HUS)" email="danaluiza.timbolschi@chru-strasbourg.fr">
                    Danaluiza;TIMBOLSCHI
                                            <ExtLink title="ROR" URI="https://ror.org/04bckew43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="266700574" 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 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">
                        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">From an epidemiological standpoint: 1) Determination of frequency (in terms of prevalence) and distribution of congenital malformation; 2) Identification of the risk factors of malformations (discomfort, environment, medications and toxic) 3) Determination of malformation ""clusters"" for decision aids in the event of a significant increase in the prevalence of a malformation type (monitoring-alert); 4) Making data available for epidemiological studies From a public health standpoint 1) Assessment of the impact of health policies in the field of perinatal medicine and the impact of regional obstetric practices; 2) Measuring the effectiveness of the prevention and establishment of support to inform healthcare professionals, especially in the field of teratology; 3) Assessment of healthcare requirements in perinatal medicine (birthing methods and locations); From a clinical standpoint: 1) Locating new malformation associations and even the identification of new symptoms; 2) Determination of modes of genetic disorder transmission; 3) Establishment of interactions among various active partners in prevention, socio-educational care in the region concerned.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2005-01-01"/>
      <collDate event="end" date="2004-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Grand Est</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">Reported cases of malformations visible at the clinical and visceral examination, as well as identified or non-identified malformation syndromes, including those linked to chromosomal defects until two years old.. Recorded cases in the both Alsace départements and where parents are only residing both Alsace départements.                    </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>CIM10 for malformations and diseases</standardName>
          <standardName>ATC code for medication.</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</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>About 700 cases per year since 2005. About 450 cases per year since 2005.</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Individual data: on request.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Free access</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
