{"doc_desc":{"title":"Cohorte de femmes enceintes en Haute-Garonne: effet de l'exposition aux diff\u00e9rents m\u00e9dicaments sur le nouveau-n\u00e9","idno":"FRESH-PEF60124-fr","producers":[{"name":"Christine DAMASE-MICHEL","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60124-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60124"},{"agency":"FReSH","code":"FRESH-PEF60124"}]},"title":"Cohorte de femmes enceintes en Haute-Garonne: effet de l'exposition aux diff\u00e9rents m\u00e9dicaments sur le nouveau-n\u00e9","alternate_title":"EFEMERIS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Christine;DAMASE-MICHEL","PILabo":"UNITE DE PHARMACOEPIDEMIOLOGIE : EVALUATION DE L'EXPOSITION ET DU RISQUE MEDICAMENTEUX \/ SERVICE DE PHARMACOLOGIE CLINIQUE UNITE \u00ab MEDICAMENTS, GROSSESSE ET ALLAITEMENT \u00bb UMR 1027, Equipe 6","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ORCID","uri":"0000-0001-5018-0108","role":"pi id"},{"title":"IdRef","uri":"05793990X","role":"pi id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"title":"RNSR","uri":"201119369K","role":"labo id"}],"email":"medrepro@chu-toulouse.fr","isContact":"Oui"},{"type":"investigator","name":"Isabelle;LACROIX","PILabo":"UNITE DE PHARMACOEPIDEMIOLOGIE : EVALUATION DE L'EXPOSITION ET DU RISQUE MEDICAMENTEUX \/ SERVICE DE PHARMACOLOGIE CLINIQUE UNITE \u00ab MEDICAMENTS, GROSSESSE ET ALLAITEMENT \u00bb UMR 1027","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ORCID","uri":"0000-0001-7344-7282","role":"pi id"},{"title":"IdRef","uri":"280447841","role":"pi id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"title":"RNSR","uri":"201119369K","role":"labo id"}],"email":"medrepro@chu-toulouse.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]}]},"distribution_statement":{"contact":[{"name":"Christine;DAMASE-MICHEL","email":"medrepro@chu-toulouse.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]},{"name":"Isabelle;LACROIX","email":"medrepro@chu-toulouse.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"remboursables"},{"keyword":"prescrits"},{"keyword":"d\u00e9livr\u00e9s"},{"keyword":"dates de d\u00e9livrance"},{"keyword":"nouveau-n\u00e9s"},{"keyword":"donn\u00e9es disponibles"},{"keyword":"pathologies n\u00e9onatales"},{"keyword":"interruptions m\u00e9dicales de grossesse"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"grossesse"},{"keyword":"m\u00e9dicaments"},{"keyword":"d\u00e9veloppement psychomoteur"},{"keyword":"anomalies cong\u00e9nitales"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"anatomopathologie"},{"keyword":"pharmacologie"}],"topics":[{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Constituer une cohorte de femmes enceintes en poursuivant l\u2019enregistrement des m\u00e9dicaments qui leur sont prescrits et d\u00e9livr\u00e9s (pendant la grossesse) et des issues de leur grossesse, afin de rechercher les effets potentiels de l\u2019exposition aux diff\u00e9rents m\u00e9dicaments sur le nouveau-n\u00e9 (pr\u00e9maturit\u00e9, malformations, pathologies n\u00e9onatales, d\u00e9veloppement psychomoteur). Objectifs secondaires : - Assurer un r\u00f4le d\u2019alerte sur le plan des effets malformatifs. - Mettre en \u00e9vidence l\u2019innocuit\u00e9 potentielle d\u2019autres m\u00e9dicaments encore mal \u00e9valu\u00e9s.","abstract":"","coll_dates":[{"start":"2004-01-01","end":"2017-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Occitanie']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" femmes prises en charge par le r\u00e9gime g\u00e9n\u00e9ral de la caisse primaire d\u2019assurance maladie ayant accouch\u00e9 en Haute-Garonne ; - femmes ne s\u2019opposant pas a ce que nous acc\u00e9dions aux donn\u00e9es les concernant ; - femmes pour lesquelles au moins un certificat de sant\u00e9 du nouveau-n\u00e9 aura \u00e9t\u00e9 enregistr\u00e9 au niveau de la protection maternelle et infantile ou dont l\u2019issue de grossesse a \u00e9t\u00e9 recens\u00e9e par le CHU de Toulouse.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques, comparaison de nos r\u00e9sultats avec les donn\u00e9es publi\u00e9es. Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026) Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":">= 20000 individus","response_rate":"plus de 135 0000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Christine DAMASE-MICHEL","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Site Internet d\u00e9di\u00e9 \u00e0 la base de donn\u00e9es","link":"http:\/\/www.efemeris.fr\/communications.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Non"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil des bases de donn\u00e9es aupr\u00e8s des diff\u00e9rents partenaires","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"Haute Garonne"},"dataTypes":{"clinicalDataDetails":"Naissances : donn\u00e9es issues des certificats de sant\u00e9 obligatoires \u00e0 8 jours, 9 mois et 2 ans \/ Interruptions de grossesse : donn\u00e9es cliniques du CHU","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}