{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T16:32:38Z","timestamp":1774974758907,"version":"3.50.1"},"reference-count":66,"publisher":"Elsevier BV","issue":"8","license":[{"start":{"date-parts":[[2006,12,1]],"date-time":"2006-12-01T00:00:00Z","timestamp":1164931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2006,12,1]],"date-time":"2006-12-01T00:00:00Z","timestamp":1164931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2013,7,17]],"date-time":"2013-07-17T00:00:00Z","timestamp":1374019200000},"content-version":"vor","delay-in-days":2420,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","seizure-journal.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Seizure"],"published-print":{"date-parts":[[2006,12]]},"DOI":"10.1016\/j.seizure.2006.08.008","type":"journal-article","created":{"date-parts":[[2006,10,3]],"date-time":"2006-10-03T08:04:53Z","timestamp":1159862693000},"page":"563-570","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":11,"title":["The ethics of excluding women who become pregnant while participating in clinical trials of anti-epileptic medications"],"prefix":"10.1016","volume":"15","author":[{"given":"Roy G.","family":"Beran","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.seizure.2006.08.008_bib1","series-title":"Epilepsy: a question of ethics","first-page":"9","article-title":"Ethics: a process of reflection","author":"Berglund","year":"2002"},{"key":"10.1016\/j.seizure.2006.08.008_bib2","unstructured":"Charlesworth M. Practical wisdom in medical ethics. Australian Institute of Health Law & Ethics Issue Paper No. 8, 1998."},{"key":"10.1016\/j.seizure.2006.08.008_bib3","series-title":"Principles of biomedical ethics","author":"Beauchamp","year":"1994"},{"key":"10.1016\/j.seizure.2006.08.008_bib4","series-title":"Philosophical medical ethics","author":"Gillon","year":"1985"},{"key":"10.1016\/j.seizure.2006.08.008_bib5","series-title":"Epilepsy: a question of ethics","first-page":"25","article-title":"Reflections of a clergyman after a decade of membership of ethics committees","author":"Little","year":"2002"},{"key":"10.1016\/j.seizure.2006.08.008_bib6","series-title":"Women and epilepsy","author":"Betts","year":"1998"},{"key":"10.1016\/j.seizure.2006.08.008_bib7","series-title":"Women & epilepsy","first-page":"168","article-title":"Pregnancy and teratogenicity","author":"Yerby","year":"1991"},{"key":"10.1016\/j.seizure.2006.08.008_bib8","series-title":"Women with epilepsy\u2014a handbook of health and treatment issues","author":"Morrell","year":"2003"},{"key":"10.1016\/j.seizure.2006.08.008_bib9","series-title":"Women with Epilepsy: a handbook of health and treatment issues","first-page":"215","article-title":"Risks of birth defects in children born to mothers with epilepsy","author":"Derdiarian","year":"2003"},{"key":"10.1016\/j.seizure.2006.08.008_bib11","doi-asserted-by":"crossref","first-page":"535","DOI":"10.2165\/00003495-199957040-00006","article-title":"Treatment of epilepsy in pregnancy","volume":"57","author":"Nulman","year":"1999","journal-title":"Drugs"},{"issue":"Suppl. 2","key":"10.1016\/j.seizure.2006.08.008_bib12","first-page":"S23","article-title":"Epilepsy and women's issues: an update","volume":"4","author":"Tettenborn","year":"2002","journal-title":"Epileptic Disord"},{"key":"10.1016\/j.seizure.2006.08.008_bib13","doi-asserted-by":"crossref","first-page":"1132","DOI":"10.1056\/NEJM200104123441504","article-title":"The teratogenicity of anti-epileptic drugs","volume":"344","author":"Holmes","year":"2001","journal-title":"N Engl J Med"},{"key":"10.1016\/j.seizure.2006.08.008_bib14","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1016\/S0920-1211(98)00084-9","article-title":"Congenital malformations due to anti-epileptic drugs","volume":"33","author":"Kaneko","year":"1999","journal-title":"Epilepsy Res"},{"issue":"Suppl. 6","key":"10.1016\/j.seizure.2006.08.008_bib15","first-page":"S34","article-title":"The new anti-epileptic drugs and women: Efficacy, reproductive health, pregnancy and fetal outcome","volume":"37","author":"Morrell","year":"1996","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib16","doi-asserted-by":"crossref","first-page":"938","DOI":"10.1212\/01.WNL.0000154464.36610.91","article-title":"What can we say to women of reproductive age with epilepsy","volume":"64","author":"Penovich","year":"2005","journal-title":"Neurology"},{"key":"10.1016\/j.seizure.2006.08.008_bib17","doi-asserted-by":"crossref","first-page":"860","DOI":"10.1016\/S0140-6736(67)92593-7","article-title":"Placental transfer of phenobarbitone in epileptic women and elimination in newborns","volume":"2","author":"Melchior","year":"1967","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib18","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1111\/j.1651-2227.1976.tb04941.x","article-title":"Growth retardation dysmorphic facies and minor malformations following massive exposure to phenobarbitone in utero","volume":"65","author":"Seip","year":"1976","journal-title":"Acta Paediatr Scand"},{"key":"10.1016\/j.seizure.2006.08.008_bib19","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1016\/S0022-3476(75)80604-4","article-title":"The fetal hydantoin syndrome","volume":"87","author":"Hanson","year":"1975","journal-title":"J Pediatr"},{"key":"10.1016\/j.seizure.2006.08.008_bib20","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1016\/S0022-3565(25)31040-2","article-title":"Phenytoin teratogenesis: correlation between embryopathic effect and covalent binding of putative arene oxide metabolite in gestational tissue","volume":"203","author":"Martz","year":"1977","journal-title":"J Pharmacol Exp Ther"},{"key":"10.1016\/j.seizure.2006.08.008_bib21","doi-asserted-by":"crossref","first-page":"662","DOI":"10.1016\/S0022-3476(76)80414-3","article-title":"Risks to the offspring of women treated with hydantoin anticonvulsants with emphasis on the fetal hydantoin syndrome","volume":"89","author":"Hanson","year":"1976","journal-title":"J Pediatr"},{"key":"10.1016\/j.seizure.2006.08.008_bib22","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.1056\/NEJM197311152892001","article-title":"Diphenylhydantoin and selected congenital malformations","volume":"289","author":"Monson","year":"1973","journal-title":"N Engl J Med"},{"key":"10.1016\/j.seizure.2006.08.008_bib23","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/S0140-6736(73)90467-4","article-title":"Phenytoin teratogenicity in man","volume":"1","author":"Loughnan","year":"1973","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib24","doi-asserted-by":"crossref","first-page":"746","DOI":"10.1016\/S0140-6736(85)90629-4","article-title":"Genetic predisposition to phenytoin-induced birth defects","volume":"2","author":"Strickler","year":"1985","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib25","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1002\/tera.1420030412","article-title":"Trimethadione and human teratogenesis","volume":"3","author":"German","year":"1970","journal-title":"Teratology"},{"key":"10.1016\/j.seizure.2006.08.008_bib26","doi-asserted-by":"crossref","first-page":"280","DOI":"10.1016\/S0022-3476(75)80603-2","article-title":"The fetal trimethadione syndrome","volume":"87","author":"Zackai","year":"1975","journal-title":"J Pediatr"},{"key":"10.1016\/j.seizure.2006.08.008_bib27","doi-asserted-by":"crossref","first-page":"1389","DOI":"10.1001\/archpedi.1977.02120250071012","article-title":"The fetal trimethadione syndrome: report of an additional family and further delineation of this syndrome","volume":"131","author":"Feldman","year":"1977","journal-title":"Am J Dis Child"},{"key":"10.1016\/j.seizure.2006.08.008_bib28","series-title":"Epilepsy: frequency causes and consequences","author":"Hauser","year":"1990"},{"key":"10.1016\/j.seizure.2006.08.008_bib29","doi-asserted-by":"crossref","first-page":"2803","DOI":"10.1016\/0024-3205(81)90541-5","article-title":"A new model for embryotoxicity testing: teratogenicity and pharmacokinetics of valproic acid following constant-rate administration in the mouse using human therapeutic drug and metabolite concentrations","volume":"29","author":"Nau","year":"1981","journal-title":"Life Sci"},{"key":"10.1016\/j.seizure.2006.08.008_bib30","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1016\/S0140-6736(82)90908-4","article-title":"Maternal valproic acid and congenital neural tube defects","volume":"2","author":"Robert","year":"1982","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib31","doi-asserted-by":"crossref","first-page":"1142","DOI":"10.1016\/S0140-6736(83)90656-6","article-title":"Valproate and birth defects","volume":"2","author":"Robert","year":"1983","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib32","doi-asserted-by":"crossref","first-page":"997","DOI":"10.1016\/S0022-3476(86)80949-0","article-title":"Fetal growth, major malformations and minor anomalies in infants born to women receiving valproic acid","volume":"108","author":"Jager-Roman","year":"1986","journal-title":"J Pediatr"},{"key":"10.1016\/j.seizure.2006.08.008_bib33","doi-asserted-by":"crossref","first-page":"396","DOI":"10.1016\/S0140-6736(84)90557-9","article-title":"Spina bifida and in-utero exposure to valproate","volume":"2","author":"Lindhout","year":"1984","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib34","doi-asserted-by":"crossref","first-page":"1392","DOI":"10.1016\/S0140-6736(86)91711-3","article-title":"In-utero exposure to valproate and neural tube defects","volume":"1","author":"Lindhout","year":"1986","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib35","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1111\/j.1528-1157.1984.tb04158.x","article-title":"Teratogenicity of anti-epileptic drug combinations with special emphasis on epoxidation (of carbamazepine)","volume":"25","author":"Lindhout","year":"1984","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib36","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1056\/NEJM199103073241006","article-title":"Spina bifida in infants of women treated with carbamazepine during pregnancy","volume":"324","author":"Rosa","year":"1991","journal-title":"N Engl J Med"},{"key":"10.1016\/j.seizure.2006.08.008_bib37","doi-asserted-by":"crossref","first-page":"1874","DOI":"10.1212\/01.WNL.0000163771.96962.1F","article-title":"Anti-epileptic drug use of women with epilepsy and congenital malformations in offspring","volume":"64","author":"Artama","year":"2005","journal-title":"Neurology"},{"key":"10.1016\/j.seizure.2006.08.008_bib38","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1212\/01.WNL.0000154516.43630.C5","article-title":"Increase rate of major malformations in offspring exposed to valproate during pregnancy","volume":"64","author":"Wyszynski","year":"2005","journal-title":"Neurology"},{"key":"10.1016\/j.seizure.2006.08.008_bib39","doi-asserted-by":"crossref","first-page":"955","DOI":"10.1212\/01.WNL.0000154515.94346.89","article-title":"Lamotrigine and the risk of malformations in pregnancy","volume":"64","author":"Cunnington","year":"2005","journal-title":"Neurology"},{"key":"10.1016\/j.seizure.2006.08.008_bib40","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1016\/S0920-1211(98)00094-1","article-title":"Safety of tiagabine: summary of 53 trials","volume":"33","author":"Leppik","year":"1999","journal-title":"Epilepsy Res"},{"key":"10.1016\/j.seizure.2006.08.008_bib41","doi-asserted-by":"crossref","first-page":"983","DOI":"10.1046\/j.1528-1157.2002.01702.x","article-title":"A post-marketing surveillance study of gabapentin as add-on therapy for 3100 patients in England","volume":"43","author":"Wilton","year":"2002","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib42","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1016\/S1525-5050(03)00110-0","article-title":"Gabapentin exposure in human pregnancy: results from the Gabapentin Registry","volume":"4","author":"Montouris","year":"2003","journal-title":"Epilepsy Behav"},{"key":"10.1016\/j.seizure.2006.08.008_bib43","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/S0920-1211(01)00296-0","article-title":"A systematic review of the safety profile of levetiracetam: a new anti-epileptic drug","volume":"47","author":"French","year":"2001","journal-title":"Epilepsy Res"},{"key":"10.1016\/j.seizure.2006.08.008_bib44","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1111\/j.1528-1157.1997.tb01480.x","article-title":"Maternal use of anti-epileptic drugs and risk of major congenital malformations: a joint European prospective study of human teratogenesis associated with maternal epilepsy","volume":"38","author":"Samren","year":"1997","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib45","doi-asserted-by":"crossref","first-page":"793","DOI":"10.1111\/j.1528-1157.1998.tb01166.x","article-title":"A unique public\/private partnership of health surveillance","volume":"39","author":"A North American Registry for Epilepsy and Pregnancy","year":"1998","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib46","doi-asserted-by":"crossref","first-page":"1422","DOI":"10.1046\/j.1528-1157.2001.11201.x","article-title":"Pregnancy registries in epilepsy","volume":"42","author":"Beghi","year":"2001","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib47","first-page":"250","article-title":"Report of first positive findings from hospital-based AED Pregnancy Registry","volume":"63","author":"Holmes","year":"2001","journal-title":"Teratology"},{"key":"10.1016\/j.seizure.2006.08.008_bib48","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1016\/S0967-5868(03)00158-9","article-title":"The Australian registry of anti-epileptic drugs in pregnancy: experience after 30 months","volume":"10","author":"Vajda","year":"2003","journal-title":"J Clin Neuro-Sci"},{"key":"10.1016\/j.seizure.2006.08.008_bib49","doi-asserted-by":"crossref","first-page":"854","DOI":"10.1016\/j.jocn.2004.05.003","article-title":"Critical relationship between sodium valproate dose and human teratogenicity: results of the Australian register of anti-epileptic drugs in pregnancy","volume":"11","author":"Vajda","year":"2004","journal-title":"J Clin Neuro-sci"},{"key":"10.1016\/j.seizure.2006.08.008_bib50","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1001\/archneur.61.5.673","article-title":"The AED (Anti-epileptic Drug) pregnancy registry","volume":"61","author":"Holmes","year":"2004","journal-title":"Arch Neurol"},{"issue":"Suppl. 5","key":"10.1016\/j.seizure.2006.08.008_bib51","first-page":"83","article-title":"Major and minor birth malformations and anti-epileptic drugs","volume":"42","author":"Koch","year":"1992","journal-title":"Neurology"},{"key":"10.1016\/j.seizure.2006.08.008_bib52","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1136\/jnnp.2005.074203","article-title":"Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register","volume":"77","author":"Morrow","year":"2006","journal-title":"J Neurol Neurosurg Psych"},{"key":"10.1016\/j.seizure.2006.08.008_bib53","doi-asserted-by":"crossref","first-page":"884","DOI":"10.1016\/S0140-6736(78)90240-4","article-title":"Is the epileptic genotype teratogenic","volume":"1","author":"Fraser","year":"1978","journal-title":"Lancet"},{"key":"10.1016\/j.seizure.2006.08.008_bib54","series-title":"Epilepsy, pregnancy and the child","first-page":"267","article-title":"The frequency of congenital malformations in relatives of patients with epilepsy","author":"Annegers","year":"1982"},{"key":"10.1016\/j.seizure.2006.08.008_bib55","series-title":"Epilepsy and pregnancy","first-page":"135","article-title":"Effects of maternal seizures on the fetus","author":"Hiilesmaa","year":"1996"},{"issue":"Suppl. 8","key":"10.1016\/j.seizure.2006.08.008_bib56","first-page":"230","article-title":"Effects of partial seizures on the infants of women with epilepsy","volume":"38","author":"Ramos","year":"1997","journal-title":"Epilepsia"},{"key":"10.1016\/j.seizure.2006.08.008_bib57","first-page":"13","article-title":"Fetal heart rate during materanal grand mal epileptic seizures","volume":"7","author":"Teramo","year":"1979","journal-title":"J Peri Nat Med"},{"key":"10.1016\/j.seizure.2006.08.008_bib58","doi-asserted-by":"crossref","first-page":"796","DOI":"10.1056\/NEJM197710132971502","article-title":"Natural history of lactic acidosis after grand-mal seizures. A model for the study of an arion-gap acidosis not associated with hyperkalemia","volume":"297","author":"Oringer","year":"1977","journal-title":"N Engl J Med"},{"key":"10.1016\/j.seizure.2006.08.008_bib59","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1111\/j.1469-8749.1990.tb16959.x","article-title":"Specific cognitive dysfunction in children with epileptic mothers","volume":"32","author":"Gaily","year":"1990","journal-title":"Dev Med Child Neurol"},{"key":"10.1016\/j.seizure.2006.08.008_bib60","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1212\/01.WNL.0000154514.82948.69","article-title":"Neuropsychological effects of exposure to anti-convulsant medication in intero","volume":"64","author":"Vinten","year":"2005","journal-title":"Neurology"},{"issue":"Suppl.","key":"10.1016\/j.seizure.2006.08.008_bib61","first-page":"S22","article-title":"Diagnosis of intracranial haemorrhage in utero-after a maternal seizure","volume":"65","author":"Minkoff","year":"1985","journal-title":"Obstet Gynaecol"},{"key":"10.1016\/j.seizure.2006.08.008_bib62","series-title":"ICH Harmonised Tripartite Guideline for Good Clinical Practice","year":"1997"},{"key":"10.1016\/j.seizure.2006.08.008_bib63","series-title":"ICH Harmonised Tripartite Guideline for Good Clinical Practice","year":"1997"},{"key":"10.1016\/j.seizure.2006.08.008_bib64","unstructured":"World Medical Association Declaration of Helsinki (1989). Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by 29th World Medical Assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice, Italy, October 1983; 41st World Medical Assembly, Hong Kong, September 1989; 48th World Medical Assembly, South Africa 1996; 52nd World Medical Assembly, Scotland, 2000, Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002. Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004."},{"key":"10.1016\/j.seizure.2006.08.008_bib65","series-title":"Epilepsy: a question of ethics","first-page":"181","article-title":"Ethical considerations with clinical research\u2013with special focus upon clinical drug trials","author":"Beran","year":"2002"},{"key":"10.1016\/j.seizure.2006.08.008_bib66","unstructured":"National Health & Medical Research Council National statement on ethical conduct in research involving humans Cth of Australia, June 1999."},{"issue":"Suppl. 3","key":"10.1016\/j.seizure.2006.08.008_bib67","first-page":"S2","article-title":"Current treatments of epilepsy","volume":"64","author":"Nadkarmi","year":"2005","journal-title":"Neurology"}],"container-title":["Seizure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S105913110600166X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S105913110600166X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T01:35:16Z","timestamp":1761010516000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S105913110600166X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,12]]},"references-count":66,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2006,12]]}},"alternative-id":["S105913110600166X"],"URL":"https:\/\/doi.org\/10.1016\/j.seizure.2006.08.008","relation":{},"ISSN":["1059-1311"],"issn-type":[{"value":"1059-1311","type":"print"}],"subject":[],"published":{"date-parts":[[2006,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"The ethics of excluding women who become pregnant while participating in clinical trials of anti-epileptic medications","name":"articletitle","label":"Article Title"},{"value":"Seizure","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.seizure.2006.08.008","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2006 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}]}}