{"doc_desc":{"title":"Cohorte de femmes enceintes en situation de pr\u00e9carit\u00e9 sociale","idno":"FRESH-PEF5015-fr","producers":[{"name":"Elie AZRIA","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5015-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5015"},{"agency":"FReSH","code":"FRESH-PEF5015"}]},"title":"Cohorte de femmes enceintes en situation de pr\u00e9carit\u00e9 sociale","alternate_title":"Pr\u00e9CARE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Elie;AZRIA","PILabo":"Paris Public Hospitals \/ INSERM Unit 953","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-6159-6253","role":"pi id"},{"title":"IdRef","uri":"092146120","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"eazria@hpsj.fr","isContact":"Oui"},{"type":"investigator","name":"Candice;ESTELLAT","PILabo":"Paris Public Hospitals","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-7588-1813","role":"pi id"},{"title":"IdRef","uri":"124965253","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"candice.estellat@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Philippe;RAVAUD","PILabo":"33(0)158414141 \/ Department of Epidemiology and Biostatistics","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-8264-9206","role":"pi id"},{"title":"IdRef","uri":"060251395","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.ravaud@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","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":"Elie;AZRIA","email":"eazria@hpsj.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Candice;ESTELLAT","email":"candice.estellat@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Philippe;RAVAUD","email":"philippe.ravaud@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prospective"},{"keyword":"femmes enceintes"},{"keyword":"Cohorte"},{"keyword":"multicentrique"},{"keyword":"facteurs sociaux"},{"keyword":"hospitalisation"}],"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":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Evaluer l\u2019impact de la pr\u00e9carit\u00e9 maternelle dans ses diff\u00e9rentes composantes sur le devenir obst\u00e9trico-p\u00e9diatrique et maternel et de d\u00e9composer les m\u00e9canismes liant la condition pr\u00e9caire \u00e0 un risque p\u00e9rinatal et maternel accru. Objectifs secondaires - Etudier, pour les femmes en situation pr\u00e9caire, l\u2019impact sur la survenue d\u2019\u00e9v\u00e8nements graves d\u2019un suivi hospitalier exclusif par rapport \u00e0 un suivi en ville dans le cadre du r\u00e9seau ville-h\u00f4pital. - Etude des parcours de soin des femmes en situation pr\u00e9caire. - R\u00e9pondre aux questions pos\u00e9es par les \u00e9tudes ancillaires - Identification des facteurs de risque d\u2019aggravation d\u2019une h\u00e9morragie du post partum - Impact de la pr\u00e9carit\u00e9 maternelle sur l\u2019\u00e9volution immuno-virologique des femmes enceintes infect\u00e9es par le VIH (en partenariat avec cohorte EPF-ANRS). - Impact de la pr\u00e9carit\u00e9 maternelle sur l\u2019\u00e9vitabilit\u00e9 et les dimensions d\u2019erreurs syst\u00e9miques dans les \u00e9v\u00e8nements ind\u00e9sirables graves survenant en cours de grossesse: PREVIANS). - D\u00e9finition des valeurs normales de diff\u00e9rents marqueurs biologiques au cours de la grossesse (PreCARE Bio). - Identifier les d\u00e9terminants socio-\u00e9conomiques de la consommation des soins des femmes enceintes (URC ECO APHP) - Identifier les d\u00e9terminants socio-\u00e9conomiques de la consommation des soins des nouveaux n\u00e9s (0 \u00e0 28j) (URC ECO APHP)","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"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\": \"Toutes les femmes inscrites pour accoucher ou accouchant dans une des 4 maternit\u00e9s des centres participants (Bichat-Claude Bernard, Robert Debr\u00e9, Louis Mourier, Beaujon).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[10000-20000[ individus","response_rate":"10413"},"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":"07-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"Non","contributorName":"Elie AZRIA","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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 de pr\u00e9carit\u00e9 recueillies par un auto-questionnaire en d\u00e9but de grossesse et en fin de grossesse, et donn\u00e9es m\u00e9dicales par des fiches de synth\u00e8se remplies par les sages femmes ou les obst\u00e9triciens. Les donn\u00e9es figurant de fa\u00e7on a priori claire dans le dossier m\u00e9dical (donn\u00e9es d\u00e9mographiques, date d\u00e9but de grossesse, date d\u2019accouchement, ) pouvant \u00eatre recueillies r\u00e9trospectivement.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Suivi de grossesse, Morbidit\u00e9 \/ mortalit\u00e9 maternelle, Morbidit\u00e9 \/ mortalit\u00e9 n\u00e9onatale","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"}