<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF73499-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>Clinical and laboratory epidemiological monitoring of pregnant women with evaluation of the obstetric, foetal and neonatal risk associated with SARS-CoV-2 during the COVID-19 pandemic COroFET</titl>
      <IDNo>FRESH-PEF73499-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" role="">CHARLOTTE DUBUCS</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Clinical and laboratory epidemiological monitoring of pregnant women with evaluation of the obstetric, foetal and neonatal risk associated with SARS-CoV-2 during the COVID-19 pandemic COroFET            </titl>
      <altTitl>
                    COroFET                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73499-en            </IDNo>
      <IDNo agency="PEF">
                    73499                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73499                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Charlotte DUBUCS                                                                                                                            </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>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)" email="dubucs.charlotte@iuct-oncopole.fr">
                    Charlotte;DUBUCS
                                            <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>
      <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">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">In this situation in which data are crucial to understanding the effects of SARS-CoV-2 in the pregnant female population, our primary objective is to collect clinical and paraclinical data from a large sample of women recruited from our level 3 maternity unit, and to create biological and tissue collections with a view to responding to a series of questions, partly explained in the research programme, but which may also evolve as knowledge progresses.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <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">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </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">Adult females aged 18 years or over at the date of inclusion Pregnant women giving birth at the Paule de Viguier maternity unit, Toulouse University Hospital, in the study, between April 2020 and April 2021, regardless of pregnancy outcome (live births, intrauterine foetal death, termination of pregnancy, i.e. miscarriages, medical termination of pregnancy) and term Women having given their consent to take part in the study Women registered with a social security scheme (including the state welfare scheme)                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <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>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>target 3,600 by end April 2021</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
