{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T12:28:20Z","timestamp":1790166500411,"version":"4.1.0"},"reference-count":38,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2005,9,1]],"date-time":"2005-09-01T00:00:00Z","timestamp":1125532800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Reproductive Toxicology"],"published-print":{"date-parts":[[2005,9]]},"DOI":"10.1016\/j.reprotox.2005.03.012","type":"journal-article","created":{"date-parts":[[2005,6,27]],"date-time":"2005-06-27T17:07:06Z","timestamp":1119892026000},"page":"331-343","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":52,"title":["Post-marketing surveillance system for drugs in pregnancy\u201415 years experience of ENTIS"],"prefix":"10.1016","volume":"20","author":[{"given":"Christof","family":"Schaefer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doreen","family":"Hannemann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard","family":"Meister","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.reprotox.2005.03.012_bib1","first-page":"8","article-title":"Teratology information services in Europe and their contribution to the prevention of congenital anomalies","volume":"5","author":"Clementi","year":"2002","journal-title":"Community Genet"},{"key":"10.1016\/j.reprotox.2005.03.012_bib2","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1002\/tera.1420460107","article-title":"Teratogenic agent information centre: fifteen years of counseling and pregnancy follow-up","volume":"46","author":"El\u00e9fant","year":"1992","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib3","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1002\/tera.1420420607","article-title":"Experience of two teratology information services in Europe","volume":"42","author":"Garbis","year":"1990","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib4","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1002\/bdra.10150","article-title":"Communicating risks during pregnancy: a workshop on the use of data from animal developmental toxicity studies in pregnancy labels for drugs","volume":"70","author":"Scially","year":"2004","journal-title":"Birth Defects Res A"},{"key":"10.1016\/j.reprotox.2005.03.012_bib5","doi-asserted-by":"crossref","first-page":"619","DOI":"10.1016\/S0890-6238(01)00185-X","article-title":"Is this drug safe in pregnancy?","volume":"15","author":"Webster","year":"2001","journal-title":"Reprod Toxicol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib6","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1136\/jmg.39.4.251","article-title":"Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth","volume":"39","author":"Dean","year":"2002","journal-title":"J Med Genet"},{"key":"10.1016\/j.reprotox.2005.03.012_bib7","doi-asserted-by":"crossref","first-page":"1132","DOI":"10.1056\/NEJM200104123441504","article-title":"The teratogenicity of anticonvulsant drugs","volume":"344","author":"Holmes","year":"2001","journal-title":"N Engl J Med"},{"key":"10.1016\/j.reprotox.2005.03.012_bib8","doi-asserted-by":"crossref","first-page":"575","DOI":"10.1212\/01.WNL.0000044157.28073.DC","article-title":"Major malformations in offspring of women with epilepsy","volume":"60","author":"Kaaja","year":"2003","journal-title":"Neurology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib9","first-page":"241","article-title":"Teratogen Information Services\u2014the clinical raison d\u2019\u00e8tre (abstract)","volume":"19","author":"Koren","year":"2004","journal-title":"Reprod Toxicol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib10","first-page":"397","article-title":"Reproducibility of medical information obtained via the telephone vs personal interview","volume":"41","author":"Einarson","year":"1999","journal-title":"Vet Human Toxicol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib11","first-page":"79","article-title":"Need for inclusion and exclusion criteria for the structural abnormalities recorded in children born from exposed pregnancies","volume":"64","author":"Holmes","year":"1999","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib12","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1002\/(SICI)1096-9926(199908)60:2<54::AID-TERA3>3.0.CO;2-3","article-title":"The problems of using data from teratology information services (TIS) to identify putative teratogens","volume":"60","author":"Martinez-Frias","year":"1999","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib13","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1002\/(SICI)1096-9926(200005)61:5<327::AID-TERA2>3.0.CO;2-H","article-title":"More on data from teratogen information systems (TIS)","volume":"61","author":"Ornoy","year":"2000","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib14","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1002\/tera.1048","article-title":"Selection bias in teratology information service pregnancy outcome studies","volume":"64","author":"Johnson","year":"2001","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib15","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1002\/tera.10058","article-title":"Monitoring leflunomide (Arava) as a new potential teratogen","volume":"65","author":"Jones","year":"2002","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib16","unstructured":"Blettner M. How can cohort and case-control studies complement one another. Presentation, Symposium Epidemiology of Prenatal Toxicology. Annual meeting of European Network of Teratology Information Services (ENTIS). 2001."},{"key":"10.1016\/j.reprotox.2005.03.012_bib17","doi-asserted-by":"crossref","first-page":"944","DOI":"10.1002\/bdra.20090","article-title":"Postmarketing surveillance for drug safety in pregnancy: the Organization of Teratology Information Services Project","volume":"70","author":"Felix","year":"2004","journal-title":"Birth Defects Res A"},{"key":"10.1016\/j.reprotox.2005.03.012_bib18","series-title":"Arzneiverordnung in Schwangerschaft und Stillzeit","author":"Schaefer","year":"2001"},{"key":"10.1016\/j.reprotox.2005.03.012_bib19","series-title":"Drugs during pregnancy and lactation","author":"Schaefer","year":"2001"},{"key":"10.1016\/j.reprotox.2005.03.012_bib20","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1002\/(SICI)1096-9926(199901)59:1<7::AID-TERA4>3.0.CO;2-6","article-title":"High vitamin A intake in early pregnancy and major malformations: a multicenter prospective controlled study","volume":"59","author":"Mastrioacovo","year":"1999","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib21","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1002\/tera.1072","article-title":"Adverse effects of prenatal methimazole exposure","volume":"64","author":"Di Gianantonio","year":"2001","journal-title":"Teratology"},{"key":"10.1016\/j.reprotox.2005.03.012_bib22","unstructured":"Weber-Sch\u00f6ndorfer C. Calcium blocker during 1st trimester. Presentation of preliminary results. Annual meeting of European Network of Teratology Information Services (ENTIS). 2004."},{"key":"10.1016\/j.reprotox.2005.03.012_bib23","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1016\/0890-6238(96)00057-3","article-title":"The outcome of pregnancy in 689 women exposed to therapeutic doses of antidepressants. A collaborative study of the European Network of Teratology Information Services (ENTIS)","volume":"10","author":"McElhatton","year":"1996","journal-title":"Reprod Toxicol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib24","unstructured":"Garbis H, McElhatton P, et al. ENTIS collaborative study of selective serotonin reuptake inhibitors in pregnancy; in preparation."},{"key":"10.1016\/j.reprotox.2005.03.012_bib25","unstructured":"Diav-Citrin O, Arnon J, Shechtman S, et al. The safety of proton pump inhibitors in pregnancy: a multicenter prospective controlled study. Aliment Pharmacol Therap; in press."},{"key":"10.1016\/j.reprotox.2005.03.012_bib26","unstructured":"Diav-Citrin O, Shechtman S, Ornoy S, et al. The safety of haloperidol and penfluridol in pregnancy: a multicenter prospective controlled study. J Clin Psychiatr; in press."},{"key":"10.1016\/j.reprotox.2005.03.012_bib27","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1016\/j.reprotox.2004.09.002","article-title":"Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services","volume":"19","author":"Garbis","year":"2005","journal-title":"Reprod Toxicol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib28","unstructured":"Rost van Tonningen M, Schaefer C, Elefant E, et al. Pregnancy outcome after exposure to mesalazine; in preparation."},{"key":"10.1016\/j.reprotox.2005.03.012_bib29","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1016\/S0264-410X(98)00051-6","article-title":"Exposure to yellow fever vaccine in early pregnancy","volume":"17","author":"Robert","year":"1999","journal-title":"Vaccine"},{"key":"10.1016\/j.reprotox.2005.03.012_bib30","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/0301-2115(95)02524-3","article-title":"Pregnancy outcome after prenatal quinolone exposure","volume":"69","author":"Schaefer","year":"1996","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"key":"10.1016\/j.reprotox.2005.03.012_bib31","series-title":"Survival analysis. A self-learning text series: statistics for biology and health","author":"Kleinbaum","year":"1997"},{"key":"10.1016\/j.reprotox.2005.03.012_bib32","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1111\/j.2517-6161.1972.tb00899.x","article-title":"Regression models and life tables (with discussion)","volume":"34","author":"Cox","year":"1972","journal-title":"J Roy Statist Soc Ser B"},{"key":"10.1016\/j.reprotox.2005.03.012_bib33","series-title":"Survival analysis techniques for censored and truncated data","author":"Klein","year":"2003"},{"key":"10.1016\/j.reprotox.2005.03.012_bib34","unstructured":"ISDB (International Society of drug bulletins) EU: Berlin declaration on pharmacovigilance. Berlin, January 2005 (http:\/\/www.isdbweb.dspace.it\/pag\/)."},{"key":"10.1016\/j.reprotox.2005.03.012_bib35","first-page":"C760","article-title":"Arzneimittelforschung an Schwangeren Besonderer Schutz - aber kein Ausschluss aus der Forschung","volume":"100","author":"Biller-Andorno","year":"2003","journal-title":"Dtsch \u00c4rztebl"},{"key":"10.1016\/j.reprotox.2005.03.012_bib36","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1002\/bdra.10018","article-title":"Classification of drugs for teratogenic risk: an anachronistic way of counseling: a reply to Merlob and Stahl","volume":"67","author":"Briggs","year":"2003","journal-title":"Birth Defects Res A"},{"key":"10.1016\/j.reprotox.2005.03.012_bib37","first-page":"165","article-title":"Arzneimittelforschung an Schwangeren. Liberalisierung nicht erforderlich","volume":"101","author":"Schaefer","year":"2004","journal-title":"Dtsch \u00c4rztebl"},{"key":"10.1016\/j.reprotox.2005.03.012_bib38","series-title":"Epidemiology of human reproduction","author":"K\u00e4ll\u00e9n","year":"1988"}],"container-title":["Reproductive Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623805000833?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0890623805000833?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T13:22:32Z","timestamp":1760188952000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0890623805000833"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2005,9]]},"references-count":38,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2005,9]]}},"alternative-id":["S0890623805000833"],"URL":"https:\/\/doi.org\/10.1016\/j.reprotox.2005.03.012","relation":{},"ISSN":["0890-6238"],"issn-type":[{"value":"0890-6238","type":"print"}],"subject":[],"published":{"date-parts":[[2005,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Post-marketing surveillance system for drugs in pregnancy\u201415 years experience of ENTIS","name":"articletitle","label":"Article Title"},{"value":"Reproductive Toxicology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.reprotox.2005.03.012","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2005 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}