{"doc_desc":{"title":"Assessment of the Impact of Exposure to Occupational and Environmental Chemicals During Pregnancy on Pregnancy Outcome and Child Development","idno":"FRESH-PEF73143-en","producers":[{"name":"C\u00e9cile CHEVRIER","affiliation":"UNIVERSITE DE RENNES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73143-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73143"},{"agency":"FReSH","code":"FRESH-PEF73143"}]},"title":"Assessment of the Impact of Exposure to Occupational and Environmental Chemicals During Pregnancy on Pregnancy Outcome and Child Development","alternate_title":"PELAGIE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"C\u00e9cile;CHEVRIER","PILabo":"IRSET U1085 INSERM Universit\u00e9 Rennes 1","affiliationName":"UNIVERSITE DE RENNES","extlink":[{"title":"ORCID","uri":"0000-0003-3101-8222","role":"pi id"},{"title":"IdRef","uri":"095119175","role":"pi id"},{"title":"SIREN","uri":"130030513","role":"organisation id"},{"title":"RNSR","uri":"201722263E","role":"labo id"}],"email":"cecile.chevrier@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":"Europeans projects: Hi-WATE, ENRIECO, CHICOS,...","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"AGENCE NATIONALE DE SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL (ANSES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0471kz689"},{"title":"SIREN","uri":"130012024"}]},{"name":"ARS BRETAGNE","extlink":[{"title":"SIREN","uri":"130007966"}]},{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"MINISTERE DU TRAVAIL ET DES SOLIDARITES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/018k53h31"},{"title":"SIREN","uri":"110000072"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"C\u00e9cile;CHEVRIER","email":"cecile.chevrier@inserm.fr","type":"contact","affiliationName":"UNIVERSITE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/015m7wh34","role":"organisation id","title":"ROR"},{"uri":"130030513","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Solvents"},{"keyword":"Persistent Organic Polluants"},{"keyword":"Water Disinfection by-products"},{"keyword":"Pregnancy outcomes"},{"keyword":"child development. Main cohort topics: Health and environment."},{"keyword":"Pesticides"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Gynaecology and obstetrics","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":"Paediatrics","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":"Nephrology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Environmental determinants: Climate","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"General objective: to assess the impact of early-life exposure to occupational and environmental chemicals on pregnancy outcome and child development, including exposure to solvents, pesticides, persistants pollutants and chlorinated derivatives in water. Secondary objectives: - to identify environmental sources and individual determinants (socio-demographic characteristics, lifestyle, genetic susceptibility) of exposure to pollutants measured by biomarkers - to investigate the respective roles of prenatal exposure and exposure during childhood","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bretagne']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Women in their first trimester of pregnancy (less than 19 weeks amenorrhoea) living in one of the \\\"d\u00e9partements\\\" participating in the study.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"3421"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data may be used by academic teams To be decided if data may be used by industrial teams.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"09-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2023","isContributorPI":"No","contributorName":"C\u00e9cile CHEVRIER","contributorAffiliation":"UNIVERSITE DE RENNES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/PELAGIE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Private non-profit","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: manual input with double data entry Clinical examinations: manual input with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (40 centres): ILLE ET VILAINE, COTES D'ARMOR, FINISTERE"},"dataTypes":{"clinicalDataDetails":"At birth; neurospychological exaination at 6 years old; growth and pubertal developement at 12 years old","biologicalDataDetails":"Type of samples taken: umbilical cord blood, urine (prenatal, childhood), placenta fragment, hair (maternal at birth, childhood), saliva (mother, child), blood (child)","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}