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<docDscr>
  <citation>
    <titlStmt>
      <titl>Assessment of Prescribed Drugs and Associated Risk During Pregnancy</titl>
      <IDNo>FRESH-PEF60124-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" role="">Christine DAMASE-MICHEL</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Assessment of Prescribed Drugs and Associated Risk During Pregnancy            </titl>
      <altTitl>
                    EFEMERIS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60124-en            </IDNo>
      <IDNo agency="PEF">
                    60124                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60124                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Christine DAMASE-MICHEL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)">
        <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
        <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Isabelle LACROIX                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)">
        <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
        <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
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      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" email="medrepro@chu-toulouse.fr">
                    Christine;DAMASE-MICHEL
                                            <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263100125" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" email="medrepro@chu-toulouse.fr">
                    Isabelle;LACROIX
                                            <ExtLink title="ROR" URI="https://ror.org/017h5q109" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263100125" 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="">
                    newborns</keyword>
      <keyword vocab="" vocabURI="">
                    neonatal diseases</keyword>
      <keyword vocab="" vocabURI="">
                    congenital anomalies</keyword>
      <keyword vocab="" vocabURI="">
                    pregnancy</keyword>
      <keyword vocab="" vocabURI="">
                    drugs</keyword>
      <keyword vocab="" vocabURI="">
                    psychomotor development</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacology</keyword>
      <keyword vocab="" vocabURI="">
                    abortions</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="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To form a cohort of pregnant women in monitoring the registration of medication prescribed and dispensed (during pregnancy) and the outcome of these pregnancies, so as to investigate the potential effects of exposure to drugs on newborns (prematurity, malformations, neonatal pathologies, psychomotor development).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2004-01-01"/>
      <collDate event="end" date="2017-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Occitanie</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General 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 level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe clusion="I">Women with general state coverage administrated by the primary health insurance fund who gave birth in Haute-Garonne; - women who did not refuse access to information concerning them; - women who have at least one newborn health certificate registered at Mother and Child Protection level or whose pregnancy outcome has been identified by theUniversity Hospital Center .                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </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>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.) Medical-administrative database (patients</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>health insurance/mutual insurance)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&gt;= 20000 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </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">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>plus de 135,000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
