{"doc_desc":{"title":"Cohorte de femmes enceintes : infection m\u00e8re-enfant \u00e0 virus chikungunya \/ \u00e9tude ambispective","idno":"FRESH-PEF23302-fr","producers":[{"name":"Patrick GERARDIN","affiliation":"UNIVERSITE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF23302-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"23302"},{"agency":"FReSH","code":"FRESH-PEF23302"}]},"title":"Cohorte de femmes enceintes : infection m\u00e8re-enfant \u00e0 virus chikungunya \/ \u00e9tude ambispective","alternate_title":"CHIMERE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Patrick;GERARDIN","PILabo":"CHU de La R\u00e9union \/ Inserm \/Universit\u00e9 de La R\u00e9union \/ Union R\u00e9gionale des M\u00e9decins Lib\u00e9raux de l'Oc\u00e9an \/ Centre d'Investigation Clinique (CIC 1410) - ex Centre d'Investigation Clinique - Epid\u00e9miologie Clinique (CIE2)","affiliationName":"UNIVERSITE DE LA REUNION","extlink":[{"title":"ORCID","uri":"0000-0002-3276-5919","role":"pi id"},{"title":"IdRef","uri":"071614257","role":"pi id"},{"title":"SIREN","uri":"199744780","role":"organisation id"},{"title":"RNSR","uri":"200318009S","role":"labo id"}],"email":"patrick.gerardin@chu-reunion.fr","isContact":"Oui"},{"type":"investigator","name":"Xavier;FRITEL","PILabo":"2224Inserm CIC-P 1402 Centre d\u2019Investigation Clinique Plurith\u00e9matique du CHU de Poitiers. http:\/\/cic0802.labo.univ-poitiers.fr \/ Service de Gyn\u00e9cologie-Obst\u00e9trique et M\u00e9decine de la Reproduction, CHU de Poitiers, Universit\u00e9 de Poitiers, Facult\u00e9 de M\u00e9decine et Pharmacie. http:\/\/medphar.univ-poitiers.fr\/CESP UMR Inserm U1018, Equipe 7 : Genre, Sant\u00e9 Sexuelle et Reproductive.","affiliationName":"UNIVERSITE DE POITIERS","extlink":[{"title":"ORCID","uri":"0000-0002-4987-8127","role":"pi id"},{"title":"IdRef","uri":"061113972","role":"pi id"},{"title":"SIREN","uri":"198608564","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"xavier.fritel@chu-poitiers.fr","isContact":"Oui"}],"oth_id":[{"name":"R\u00e9seau Reacting sur le chikungunya aux Antilles et en Guyane","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"sponsor id"},{"title":"SIREN","uri":"200030013","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Patrick;GERARDIN","email":"patrick.gerardin@chu-reunion.fr","type":"contact","affiliationName":"UNIVERSITE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/005ypkf75","role":"organisation id","title":"ROR"},{"uri":"199744780","role":"organisation id","title":"SIREN"}]},{"name":"Xavier;FRITEL","email":"xavier.fritel@chu-poitiers.fr","type":"contact","affiliationName":"UNIVERSITE DE POITIERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04xhy8q59","role":"organisation id","title":"ROR"},{"uri":"198608564","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"virus Chikungunya"},{"keyword":"m\u00e9decine p\u00e9rinatal"},{"keyword":"transmission m\u00e8re-enfant"},{"keyword":"enc\u00e9phalite"},{"keyword":"pronostic neurod\u00e9veloppemental"},{"keyword":"\u00e9tudes de cohorte"},{"keyword":"grossesse"},{"keyword":"obst\u00e9trique"},{"keyword":"m\u00e8re"},{"keyword":"nouveau-n\u00e9"},{"keyword":"p\u00e9diatrie"},{"keyword":"enfants"},{"keyword":"enc\u00e9phalopathie"},{"keyword":"s\u00e9quelles"}],"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":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"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"}]}],"purpose":"1-Objectif principal : \u00e9valuer la pr\u00e9valence et le pronostic neurod\u00e9veloppementale de l\u2019infection materno-f\u0153tale \u00e0 Chikungunya 2-Objectifs secondaires: d\u00e9terminer les m\u00e9canismes et facteurs favorisants de la transmission materno-f\u0153tale; d\u00e9crire l\u2019infection \u00e0 Chikungunya chez la femme enceinte et le nouveau-n\u00e9; proposer une protocole de diagnostic et prise en charge des infections pendant la grossesse, la naissance et la p\u00e9riode n\u00e9onatale; valider le diagnostic viral chez le nouveau-n\u00e9 par RT-PCR au cordon; \u00e9tudier les souches virales; d\u00e9crire chez l'enfant expos\u00e9 in ut\u00e9ro \u00e0 une infection maternelle la cin\u00e9tique de s\u00e9ron\u00e9gativation des anticorps IgG transplacentaires d'origine maternelle","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\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    \"level_type_clusion_I\": \"Personnes en situation de handicap\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u00e9tude maternelle: femme enceinte ayant une couverture sociale; \u00e9tude p\u00e9diatrique: enfant n\u00e9 des femmes inclues dans la cohorte maternelle. Inclusion quelque soit l'histoire de la grossesse et l'exposition les deux premiers mois de l'\u00e9tude puis uniquement des femmes expos\u00e9es rapportant une histoire de chikungunya les six mois suivants.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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"}]},"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)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1433"},"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":"","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":"14-02-2015","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2018","isContributorPI":"Non","contributorName":"Patrick GERARDIN","contributorAffiliation":"UNIVERSITE DE LA REUNION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971208001586"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Donn\u00e9es recueillies par les m\u00e9decins hospitaliers gyn\u00e9cologues-obst\u00e9triciens, les sages-femmes, les p\u00e9diatres n\u00e9onatologistes, les psychomotriciens et neuropsychologues du CAMSP aux diff\u00e9rents points de suivi (voir plus haut).- M\u00e8res : 628 non-infect\u00e9es, 658 infect\u00e9es- Enfants: 642 non-expos\u00e9s non-infect\u00e9s, 653 expos\u00e9s-non infect\u00e9s, 33 infect\u00e9s, 591 suivis s\u00e9rologiquement,168 QD \u00e9valu\u00e9s","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Etude de cohorte conduite dans quatre maternit\u00e9s publiques: Saint Denis, Saint Louis, Saint Paul, Saint Pierre une maternit\u00e9 semi-publique semi-priv\u00e9e: Saint Beno\u00eet une maternit\u00e9 priv\u00e9e: Sainte Clotilde"},"dataTypes":{"clinicalDataDetails":"M\u00e8res: inclusions et examens cliniques, mesures anthropom\u00e9triques pendant la grossesse et\/ou \u00e0 l'accouchement. Enfants: inclusions \u00e0 la naissance, examens cliniques et mesures anthropom\u00e9triques \u00e0 la naissance, \u00e0 9-12 mois (CLAMS et b\u00e9b\u00e9-vision), 18-24 mois (QD r\u00e9vis\u00e9 de Brunet-L\u00e9zine)","biologicalDataDetails":"M\u00e8re: num\u00e9ration formule sanguine \u00e0 l'accouchement; enfant: num\u00e9ration formule sanguine \u00e0 la naissance","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}