{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T13:36:10Z","timestamp":1790688970694,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T00:00:00Z","timestamp":1777939200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T00:00:00Z","timestamp":1777939200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Besides registries, healthcare databases can provide useful information for assessing the frequency of major congenital malformations (MCMs) and investigating their risk factors, particularly medication exposures. This study aimed to assess the validity of MCMs identification based on French national, comprehensive healthcare databases.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using information on hospital discharge diagnoses, medical procedures (e.g. surgery) and death causes from the EPI\u2010MERES register nested in the French National Health Data System, 72 specific MCMs grouped in 11 organ groups were assessed among all births in France between 2010 and 2023. MCMs prevalence rates were estimated and compared to those from EUROCAT, and associations with prenatal exposure to valproate were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among a total of 10.5 million births, 213\u2009153 live\u2010born infants MCM (203.0 per 10\u2009000 births) with at least one MCM were identified. Almost half (47%) of MCMs cases were identified based on a medical procedure code. MCM prevalence rate increased by 16% between 2010\u20132012 and 2022\u20132023, from 181.2 to 211.2 cases per 10\u2009000 births. MCMs prevalence rates among live births were close to those reported in EUROCAT (overall difference: \u22121%). Prenatal exposure to valproate was significantly associated with increased risks of any MCM (adjusted odds ratio (aOR) 2.82, 95% CI [2.33\u20133.41]) and of 15 specific MCMs including spina bifida (aOR 17.88 [7.88\u201340.53]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study supports the validity of MCMs identification based on data of the EPI\u2010MERES register. The EPI\u2010MERES register provides a highly powerful, reactive and operational tool complementing MCMs registries for improving real\u2010life knowledge on drug teratogenicity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70582","type":"journal-article","created":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T14:26:49Z","timestamp":1777991209000},"page":"3037-3048","source":"Crossref","is-referenced-by-count":4,"title":["Identification of major congenital malformations based on healthcare databases in France: A proof\u2010of\u2010concept study using the epi\u2010meres nationwide mother\u2013child register"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9131-8705","authenticated-orcid":false,"given":"Tom","family":"Duchemin","sequence":"first","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lise","family":"Marty","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2017-7041","authenticated-orcid":false,"given":"J\u00e9r\u00f4me","family":"Drouin","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4163-0918","authenticated-orcid":false,"given":"Sara","family":"Miranda","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4814-6370","authenticated-orcid":false,"given":"J\u00e9r\u00e9mie","family":"Botton","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"},{"name":"Facult\u00e9 de Pharmacie Universit\u00e9 Paris\u2010Saclay  Orsay France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4837-1930","authenticated-orcid":false,"given":"Val\u00e9rie","family":"Oli\u00e9","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-9092","authenticated-orcid":false,"given":"Alain","family":"Weill","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7646-3667","authenticated-orcid":false,"given":"Rosemary","family":"Dray\u2010Spira","sequence":"additional","affiliation":[{"name":"EPI\u2010PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM] French National Health Insurance [CNAM])  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,5]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"World Health Organization \u201cBirth defects surveillance: A manual for programme managers 2nd Edition (No. cence: CC BY\u2010NC\u2010SA 3.0 IGO) \u201d Geneva 2020. Consult\u00e9 le: 30 avril 2025. [En ligne]. Disponible sur:https:\/\/www.who.int\/publications\/i\/item\/9789240015395"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.20780"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102022\u2010067033"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0907328"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD010224.pub3"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S278596"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.23206"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/PHH.0000000000000291"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/ppe.13011"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdr2.2112"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.respe.2017.05.004"},{"key":"e_1_2_9_13_1","unstructured":"MirandaS.Database profile: EPI\u2010MERES a nationwide mother\u2010child register built from the French National Health Data System (SNDS) for pregnancy and paediatric pharmacoepidemiological research Halifax Nova Scotia Canada 2023"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M22\u20100819"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.9429"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004576"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000213933"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007696"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdr2.2314"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.1784"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyz009"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41431\u2010020\u201000748\u2010y"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916\u2010017\u20100845\u20101"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018\u2010200831060\u201000008"},{"key":"e_1_2_9_25_1","unstructured":"Agence de la Biom\u00e9decine Rapport d'activit\u00e9 des Centre Pluridisciplinaires de Diagnostic Pr\u00e9natal Paris 2022."}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70582","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bcp.70582","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70582","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T08:38:31Z","timestamp":1787819911000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70582"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,5]]},"references-count":24,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/bcp.70582"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70582","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,5]]}}}