{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:46:49Z","timestamp":1787014009062,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,5,10]],"date-time":"2023-05-10T00:00:00Z","timestamp":1683676800000},"content-version":"am","delay-in-days":351,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#am"},{"start":{"date-parts":[[2022,5,24]],"date-time":"2022-05-24T00:00:00Z","timestamp":1653350400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006190","name":"Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006190","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Congenital Anomalies"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    For leukotriene receptor antagonists (LTRAs), especially pranlukast, safety data during pregnancy is limited. Therefore, we conducted a prospective, two\u2010centered cohort study using data from teratogen information services in Japan to clarify the effects of LTRA exposure during pregnancy on maternal and fetal outcomes. Pregnant women who being counseled on drug use during pregnancy at two facilities were enrolled. The primary outcome of this study was major congenital anomalies. The incidence of major congenital anomalies in women exposed to montelukast or pranlukast during the first trimester of pregnancy was compared with that of controls. Logistic regression analysis was performed to analyze the effects of maternal LTRA use during the first trimester of pregnancy on major congenital anomalies. The outcomes of 231 pregnant women exposed to LTRAs (montelukast\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a0122; pranlukast\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a0106; both\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a03) and 212 live births were compared with those of controls. The rate of major congenital anomalies in the LTRA group was 1.9%. Multivariable logistic regression analysis revealed that LTRA exposure was not a risk factor for major congenital anomalies (adjusted odds ratio, 0.78; 95% confidence interval, 0.23\u20132.05;\n                    <jats:italic>p<\/jats:italic>\n                    \u00a0=\u00a00.653). In addition, no significant difference was detected in stillbirth, spontaneous abortion, preterm birth, and low birth weight between the two groups. The present study revealed that montelukast and pranlukast were not associated with the risk of major congenital anomalies. Our findings suggest that LTRAs could be safely employed for asthma therapy during pregnancy.\n                  <\/jats:p>","DOI":"10.1111\/cga.12471","type":"journal-article","created":{"date-parts":[[2022,5,11]],"date-time":"2022-05-11T00:59:30Z","timestamp":1652230770000},"page":"161-168","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["The safety of pranlukast and montelukast during the first trimester of pregnancy: A prospective, two\u2010centered cohort study in Japan"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3653-3821","authenticated-orcid":false,"given":"Shiro","family":"Hatakeyama","sequence":"first","affiliation":[{"name":"Department of Pharmacy Yamagata University Hospital  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikako","family":"Goto","sequence":"additional","affiliation":[{"name":"The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayaka","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Yamagata University Hospital  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiro","family":"Ogura","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Yamagata University Hospital  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4045-327X","authenticated-orcid":false,"given":"Norikazu","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Yamagata University Faculty of Medicine  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiji","family":"Tsutsumi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Yamagata Prefecture Central Hospital  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naho","family":"Yakuwa","sequence":"additional","affiliation":[{"name":"The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ritsuko","family":"Yamane","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Toranomon Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Nagase","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Yamagata University Faculty of Medicine  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunihiko","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, M&amp;D Data Science Center Tokyo Medical and Dental University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rika","family":"Kosaki","sequence":"additional","affiliation":[{"name":"Division of Medical Genetics National Center for Child Health and Development  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Murashima","sequence":"additional","affiliation":[{"name":"The Japan Drug Information Institute in Pregnancy National Center for Child Health and Development  Tokyo Japan"},{"name":"Center of Maternal\u2010Fetal, Neonatal and Reproductive Medicine National Center for Child Health and Development  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Yamagata University Hospital  Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,24]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1047-2797(03)00008-5"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-3016.2007.00784.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/0091-6749(88)90187-X"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0104755"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00195111"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.12224"},{"key":"e_1_2_7_8_1","unstructured":"Ginasthma.org[Internet].Fontana: Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention;2020[cited 2020 Aug 27]. Available from:https:\/\/www.ginasthma.org"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/thx.52.6.523"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2007.01620.x"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.03.050"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2020.04.001"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40413-017-0141-8"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-009-0713-9"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2006.12.618"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.23621"},{"key":"e_1_2_7_17_1","unstructured":"Merck Pregnancy Registry for SINGULAIR (montelukast sodium). Final Report Covering the period from U.S. approval (February 20 1998) through May 15 2013."},{"issue":"6","key":"e_1_2_7_18_1","first-page":"813","article-title":"Pregnancy outcome after maternal exposure to pranlukast hydrate during first trimester: a case series study","volume":"45","author":"Yamane R","year":"2009","journal-title":"J Jpn Soc Hosp Pharm"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/jog.14709"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e318295fe12"},{"issue":"11","key":"e_1_2_7_21_1","first-page":"1976","article-title":"Pregnancy outcomes of exposure to methimazole (POEM) study","volume":"70","author":"Arata N","year":"2012","journal-title":"Nihon Rinsho"},{"key":"e_1_2_7_22_1","unstructured":"EUROCATGuide 1.4 and Reference Documents (Last update version 15\/11\/2019). Available from URL:https:\/\/eu-rd-platform.jrc.ec.europa.eu\/sites\/default\/files\/JRC-EUROCAT-Full-Guide-1.4-version-15-Nov-2019.pdf"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.09.003"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2005.049718"}],"container-title":["Congenital Anomalies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cga.12471","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cga.12471","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/am-pdf\/10.1111\/cga.12471","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cga.12471","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T01:20:16Z","timestamp":1692840016000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cga.12471"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,24]]},"references-count":23,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1111\/cga.12471"],"URL":"https:\/\/doi.org\/10.1111\/cga.12471","archive":["Portico"],"relation":{},"ISSN":["0914-3505","1741-4520"],"issn-type":[{"value":"0914-3505","type":"print"},{"value":"1741-4520","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,24]]},"assertion":[{"value":"2021-11-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}