{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T19:16:22Z","timestamp":1793733382838,"version":"4.6.1"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,12,18]],"date-time":"2023-12-18T00:00:00Z","timestamp":1702857600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017596","name":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017596","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002999","name":"Ministerie van Volksgezondheid, Welzijn en Sport","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002999","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Psychiatr Scand"],"published-print":{"date-parts":[[2024,11]]},"abstract":"Abstract<\/jats:title>Objective<\/jats:title>In recent years, safety concerns about modafinil exposure during pregnancy have emerged. In particular, increased risks for major congenital anomalies (MCA) and impaired fetal growth were reported, although study results were conflicting. Our investigation aims to examine previously reported safety signals.<\/jats:p><\/jats:sec>Method<\/jats:title>Multicenter case series based on data from 18 Teratology Information Services from 12 countries. Modafinil exposed pregnancies with an estimated date of birth before August 2019 were included in this study. For prospectively ascertained pregnancies, cumulative incidences of pregnancy outcomes, rate of nonchromosomal MCA in first trimester exposed pregnancies and percentiles of neonatal\/infant weight and head circumference (HC) were calculated. Potential dose\u2010dependent effects on fetal growth were explored by linear regression models. Retrospectively ascertained cases were screened for pattern of MCA and other adverse events.<\/jats:p><\/jats:sec>Results<\/jats:title>One hundred and seventy\u2010five prospectively ascertained cases were included, of which 173 were exposed at least during the first trimester. Cumulative incidences for live birth, spontaneous abortion and elective termination of pregnancy were 76.9% (95% CI, 68.0%\u201384.8%), 9.3% (95% CI, 5.0%\u201316.9%), and 13.9% (95% CI, 8.1%\u201323.1%), respectively. Nonchromosomal MCA was present in 3\/150 live births, corresponding to an MCA rate of 2.0% (95%CI, 0.6%\u20136.1%), none were reported in pregnancy losses. Compared to reference standards, birth weight (BW) tended to be lower and neonatal HC to be smaller in exposed newborns (data available for 144 and 73 of 153 live births, respectively). In nonadjusted linear regression models, each 100\u2009mg increase of average dosage per pregnancy day was associated with a decrease in standard deviation score (SDS) of \u22120.28 SDS (95% CI, \u22120.45 to \u22120.10) for BW and of \u22120.28 SDS (95% CI, \u22120.56 to 0.01) for HC. Screening of 22 retrospectively reported cases did not reveal any specific pattern of MCA or other adverse outcomes.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>The results do not indicate an increased risk of MCA after in utero exposure to modafinil, but a tendency toward lower BW and reduced neonatal HC. However, these findings should be regarded as preliminary. Until further studies allow for a definite conclusion, modafinil should not be used during pregnancy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acps.13643","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T06:05:46Z","timestamp":1702965946000},"page":"372-384","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Effects of maternal modafinil treatment on fetal development and neonatal growth parameters \u2014 a multicenter case series of the European Network of Teratology Information Services (ENTIS)"],"prefix":"10.1111","volume":"150","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4385-612X","authenticated-orcid":false,"given":"Marlies","family":"Onken","sequence":"first","affiliation":[{"name":"Charit\u00e9 \u2010 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lukas","family":"Lohse","sequence":"additional","affiliation":[{"name":"Charit\u00e9 \u2010 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9n\u00e9dicte","family":"Coulm","sequence":"additional","affiliation":[{"name":"AP\u2010HP.Sorbonne Universit\u00e9, H\u00f4pital Trousseau, D\u00e9partement de Sant\u00e9 Publique, Centre de R\u00e9f\u00e9rence sur les Agents T\u00e9ratog\u00e8nes (CRAT) Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Beghin","sequence":"additional","affiliation":[{"name":"AP\u2010HP.Sorbonne Universit\u00e9, H\u00f4pital Trousseau, D\u00e9partement de Sant\u00e9 Publique, Centre de R\u00e9f\u00e9rence sur les Agents T\u00e9ratog\u00e8nes (CRAT) Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan L.","family":"Richardson","sequence":"additional","affiliation":[{"name":"UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Bermejo\u2010S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Institute of Rare Diseases Research (IIER), Research Unit on Congenital Anomalies\u2010UIAC and Spanish Teratology Information Services SITTE and SITE, Instituto Salud Carlos III (ISCIII) Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Aguilera","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Service Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat","family":"Bosch","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Service Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Cassina","sequence":"additional","affiliation":[{"name":"Clinical Genetics Unit, Department of Women's and Children's Health University of Padova Padova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Chouchana","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2010H\u00f4pitaux de Paris, H\u00f4pital Cochin, Service de pharmacologie p\u00e9rinatale, p\u00e9diatrique et adulte Centre R\u00e9gional de Pharmacovigilance Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"De Santis","sequence":"additional","affiliation":[{"name":"Teratology Information Service Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mine Kadioglu","family":"Duman","sequence":"additional","affiliation":[{"name":"Teratology Information Service, Department of Pharmacology, Faculty of Medicine Karadeniz Technical University Trabzon Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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