{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T13:44:36Z","timestamp":1793108676041,"version":"4.5.0"},"reference-count":29,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100006451","name":"Hospices Civils de Lyon","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006451","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Reproductive Toxicology"],"published-print":{"date-parts":[[2025,9]]},"DOI":"10.1016\/j.reprotox.2025.108958","type":"journal-article","created":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T11:24:03Z","timestamp":1748949843000},"page":"108958","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"special_numbering":"C","title":["The use of pregabalin in early pregnancy and major congenital malformations: A systematic review and meta-analysis"],"prefix":"10.1016","volume":"136","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5735-4905","authenticated-orcid":false,"given":"Marina","family":"Atzenhoffer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Peron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyndie","family":"Picot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Cucherat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Cottin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.reprotox.2025.108958_bib1","unstructured":"E.M.A., Lyrica, European Medicines Agency 2018. \u3008https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/lyrica\u3009 (accessed August 22, 2023)."},{"key":"10.1016\/j.reprotox.2025.108958_bib2","series-title":"StatPearls","article-title":"Pregabalin","author":"Cross","year":"2024"},{"key":"10.1016\/j.reprotox.2025.108958_bib3","doi-asserted-by":"crossref","first-page":"695","DOI":"10.1001\/jamainternmed.2019.0086","article-title":"A clinical overview of off-label use of gabapentinoid drugs","volume":"179","author":"Goodman","year":"2019","journal-title":"JAMA Intern. Med."},{"key":"10.1016\/j.reprotox.2025.108958_bib4","doi-asserted-by":"crossref","first-page":"1235","DOI":"10.1007\/s40264-020-00985-6","article-title":"Current evidence on abuse and misuse of gabapentinoids","volume":"43","author":"H\u00e4gg","year":"2020","journal-title":"Drug Saf."},{"key":"10.1016\/j.reprotox.2025.108958_bib5","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1002\/bdrb.21174","article-title":"Embryo-Fetal developmental toxicity studies with pregabalin in mice and rabbits","volume":"107","author":"Morse","year":"2016","journal-title":"Birth Defects Res. B Dev. Reprod. Toxicol."},{"key":"10.1016\/j.reprotox.2025.108958_bib6","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1002\/bdrb.21175","article-title":"Developmental toxicity studies with pregabalin in rats: significance of alterations in skull bone morphology","volume":"107","author":"Morse","year":"2016","journal-title":"Birth Defects Res. B Dev. Reprod. Toxicol."},{"key":"10.1016\/j.reprotox.2025.108958_bib7","doi-asserted-by":"crossref","first-page":"2251","DOI":"10.1212\/WNL.0000000000002767","article-title":"Pregnancy outcome following maternal exposure to pregabalin May call for concern","volume":"86","author":"Winterfeld","year":"2016","journal-title":"Neurology"},{"key":"10.1016\/j.reprotox.2025.108958_bib8","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1007\/s40264-023-01307-2","article-title":"Prenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four nordic countries","volume":"46","author":"Dudukina","year":"2023","journal-title":"Drug Saf."},{"key":"10.1016\/j.reprotox.2025.108958_bib9","unstructured":"Actualit\u00e9 - Le risque de malformation chez les enfants expos\u00e9s pendant la grossesse \u00e0 la pr\u00e9gabaline est confirm\u00e9, ANSM (n.d.). \u3008https:\/\/ansm.sante.fr\/actualites\/le-risque-de-malformation-chez-les-enfants-exposes-pendant-la-grossesse-a-la-pregabaline-est-confirme\u3009 (accessed October 15, 2024)."},{"key":"10.1016\/j.reprotox.2025.108958_bib10","doi-asserted-by":"crossref","first-page":"e167","DOI":"10.1212\/WNL.0000000000007696","article-title":"Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs","volume":"93","author":"Bloti\u00e8re","year":"2019","journal-title":"Neurology"},{"key":"10.1016\/j.reprotox.2025.108958_bib11","doi-asserted-by":"crossref","first-page":"2020","DOI":"10.1212\/WNL.0000000000003959","article-title":"Pregabalin use early in pregnancy and the risk of major congenital malformations","volume":"88","author":"Patorno","year":"2017","journal-title":"Neurology"},{"key":"10.1016\/j.reprotox.2025.108958_bib12","unstructured":"Cochrane Handbook for Systematic Reviews of Interventions, (n.d.). \u3008https:\/\/handbook-5-1.cochrane.org\/\u3009 (accessed September 9, 2020)."},{"key":"10.1016\/j.reprotox.2025.108958_bib13","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1000097","article-title":"PRISMA group, preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement","volume":"6","author":"Moher","year":"2009","journal-title":"PLOS Med."},{"key":"10.1016\/j.reprotox.2025.108958_bib14","doi-asserted-by":"crossref","first-page":"2008","DOI":"10.1001\/jama.283.15.2008","article-title":"S.B. Thacker, Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group","volume":"283","author":"Stroup","year":"2000","journal-title":"JAMA"},{"key":"10.1016\/j.reprotox.2025.108958_bib15","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1186\/s13643-023-02256-8","article-title":"Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metapreg project","volume":"12","author":"Picot","year":"2023","journal-title":"Syst. Rev."},{"key":"10.1016\/j.reprotox.2025.108958_bib16","doi-asserted-by":"crossref","DOI":"10.1002\/14651858.CD010224.pub2","article-title":"Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child","author":"Weston","year":"2016","journal-title":"Cochrane Database Syst. Rev. 11"},{"key":"10.1016\/j.reprotox.2025.108958_bib17","unstructured":"Chapter 8: Assessing risk of bias in a randomized trial, (n.d.). \u3008https:\/\/training.cochrane.org\/handbook\/current\/chapter-08\u3009 (accessed October 15, 2024)."},{"key":"10.1016\/j.reprotox.2025.108958_bib18","unstructured":"ROBINS-I | Cochrane Bias, (n.d.). \u3008https:\/\/methods.cochrane.org\/bias\/risk-bias-non-randomized-studies-interventions\u3009 (accessed September 24, 2024)."},{"key":"10.1016\/j.reprotox.2025.108958_bib19","doi-asserted-by":"crossref","unstructured":"G. Schwarzermeta: An R Package for Meta-Analysis, 7 2007.","DOI":"10.32614\/CRAN.package.meta"},{"key":"10.1016\/j.reprotox.2025.108958_bib20","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1002\/sim.1186","article-title":"Quantifying heterogeneity in a meta-analysis","volume":"21","author":"Higgins","year":"2002","journal-title":"Stat. Med."},{"key":"10.1016\/j.reprotox.2025.108958_bib21","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1136\/bmj.315.7109.629","article-title":"Bias in meta-analysis detected by a simple, graphical test","volume":"315","author":"Egger","year":"1997","journal-title":"BMJ"},{"key":"10.1016\/j.reprotox.2025.108958_bib22","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1111\/j.0006-341X.2000.00455.x","article-title":"Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis","volume":"56","author":"Duval","year":"2000","journal-title":"Biometrics"},{"key":"10.1016\/j.reprotox.2025.108958_bib23","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1001\/jamaneurol.2024.0258","article-title":"Risk of major congenital malformations and exposure to antiseizure medication monotherapy","volume":"81","author":"Battino","year":"2024","journal-title":"JAMA Neurol."},{"key":"10.1016\/j.reprotox.2025.108958_bib24","doi-asserted-by":"crossref","first-page":"579","DOI":"10.1007\/s00415-013-7239-x","article-title":"Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy","volume":"261","author":"Veiby","year":"2014","journal-title":"J. Neurol."},{"key":"10.1016\/j.reprotox.2025.108958_bib25","unstructured":"L.B. Holmes, The North American AED Pregnancy Registry, (n.d.). \u3008https:\/\/www.aedpregnancyregistry.org\/dernieres-donnees\/?lang=fr\u3009 (accessed August 3, 2022)."},{"key":"10.1016\/j.reprotox.2025.108958_bib26","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1016\/j.seizure.2018.12.006","article-title":"Antiepileptic drugs and foetal malformation: analysis of 20 years of data in a pregnancy register","volume":"65","author":"Vajda","year":"2019","journal-title":"Seizure"},{"key":"10.1016\/j.reprotox.2025.108958_bib27","doi-asserted-by":"crossref","first-page":"1221","DOI":"10.3390\/ph6101221","article-title":"The use of central nervous system active drugs during pregnancy","volume":"6","author":"K\u00e4ll\u00e9n","year":"2013","journal-title":"Pharmaceuticals"},{"key":"10.1016\/j.reprotox.2025.108958_bib28","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1001\/jamaneurol.2022.1269","article-title":"Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability","volume":"79","author":"Bj\u00f8rk","year":"2022","journal-title":"JAMA Neurol."},{"key":"10.1016\/j.reprotox.2025.108958_bib29","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-020-74409-x","article-title":"Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs: a nationwide cohort study in France","volume":"10","author":"Coste","year":"2020","journal-title":"Sci. Rep."}],"container-title":["Reproductive Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623825001297?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623825001297?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T15:34:03Z","timestamp":1752593643000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0890623825001297"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":29,"alternative-id":["S0890623825001297"],"URL":"https:\/\/doi.org\/10.1016\/j.reprotox.2025.108958","relation":{},"ISSN":["0890-6238"],"issn-type":[{"value":"0890-6238","type":"print"}],"subject":[],"published":{"date-parts":[[2025,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"The use of pregabalin in early pregnancy and major congenital malformations: A systematic review and meta-analysis","name":"articletitle","label":"Article Title"},{"value":"Reproductive Toxicology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.reprotox.2025.108958","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"108958"}}