<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Paris Registry of Congenital Malformations</titl>
      <IDNo>FRESH-PEF221-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Babak KHOSHNOOD</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Paris Registry of Congenital Malformations            </titl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF221-en            </IDNo>
      <IDNo agency="PEF">
                    221                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF221                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Babak KHOSHNOOD                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <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>
      <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="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="babak.khoshnood@inserm.fr">
                    Babak;KHOSHNOOD
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" 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 defects prenatal diagnosis</keyword>
      <topcClas vocab="cim-11">
                        Gambling disorder, predominantly online                                            </topcClas>
    </subject>
    <abstract contentType="purpose">1. Provide epidemiological surveillance of congenital defects in the Parisian population, with the objective of an alert faced with any teratogens from the environment (e.g.: medication, industrial accident), and this, on a local, national and international scale. In the event of an abnormal change in the frequency of a defect, additional investigations are conducted, with a search for special risk factors, and also recording or recruiting bias that can result in a false alarm. 2. Assess in the population the impact of the health initiatives: - Evaluating the prenatal screening of malformations is a basic objective of the registry, and this even more so as this screening has developed substantially in France since the 1980s. - Evaluating preventive initiatives is also important, and especially that of the impact of the primary prevention policy of neural tube defects by periconceptional folic acid supplementation, implemented in France starting in the year 2000. 3. Conduct studies in collaboration with specialized clinical services, in particular for assessing in the population the future of children who carry certain incapacitating malformations. 4. Contribute to etiological research, in particular within the framework of collaborative and multi-center studies. This can entail case/control studies or cohorts set up for particular research questions.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1981-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Ile-de-France</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 clusion="I">The Registry includes the cases of chromosomal anomalies and structural birth defects among live births, and the still-born (22 weeks of amenorrhea or more), as well as pregnancy terminations for fetal anomalies regardless of the gestational age at termination.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</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>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&gt;= 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>1981-2008: more than 34 000 cases 2008 : 1409 cases</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>access to anonymous data is possible with a study protocol after approval by the Registry team and Inserm Unit 953</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
