{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T21:05:08Z","timestamp":1792271108162,"version":"4.4.0"},"reference-count":34,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T00:00:00Z","timestamp":1589760000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Ondansetron is increasingly used off label to treat nausea and vomiting during pregnancy. The main objective of this study was to evaluate the risk of major congenital malformations (MCM), cardiac defects and orofacial clefts associated with first trimester exposure to ondansetron using a meta\u2010analytic approach. MEDLINE,\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    and Scopus were searched until November 2019. All comparative cohort and case\u2013control studies on MCM, cardiac or orofacial defects and use of ondansetron during pregnancy were included. A team of paired reviewers independently extracted data using a proprietary collaborative WEB\u2010based meta\u2010analysis platform (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/metaPreg.org\">metaPreg.org<\/jats:ext-link>\n                    ). Pooled odd ratios with corresponding 95% CIs were calculated using random effects models. From 214 records initially retrieved, 12 studies were included. Using all available information to date, first trimester exposure to ondansetron was found to be associated with an increased risk of (a) ventricular septal defects (VSD) (OR 1.11, 95% CI 1.00\u20131.23;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u2009.05;\n                    <jats:italic>n<\/jats:italic>\n                    = 6 studies;\n                    <jats:italic>I<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    =\u20090%) and (b) oral clefts (OR 1.22, 95% CI 1.00\u20131.49;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u2009.05;\n                    <jats:italic>n<\/jats:italic>\n                    = 4 studies;\n                    <jats:italic>I<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    =\u20090%). No significant association was observed for the risk of cleft palate but, when excluding the study that contributed to the study heterogeneity, we found an OR of 1.48 (95% CI 1.19\u20131.84;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u2009.01;\n                    <jats:italic>n<\/jats:italic>\n                    = 5 studies;\n                    <jats:italic>I<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    =\u20090%). No statistically significant association was found for MCM, overall cardiac malformations, atrial septal defects and cleft lip with or without cleft palate. Exploratory investigations of other malformations showed an increased risk of diaphragmatic hernia, hypoplastic left heart and \u201crespiratory system anomalies.\u201d\n                  <\/jats:p>","DOI":"10.1002\/bdr2.1705","type":"journal-article","created":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T05:54:21Z","timestamp":1589781261000},"page":"996-1013","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Risk of malformation after ondansetron in pregnancy: An updated systematic review and meta\u2010analysis"],"prefix":"10.1002","volume":"112","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8843-5417","authenticated-orcid":false,"given":"Cyndie","family":"Picot","sequence":"first","affiliation":[{"name":"Service Hospitalo\u2010Universitaire de Pharmaco\u2010Toxicologie, Hospices Civils de Lyon  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7535-5517","authenticated-orcid":false,"given":"Anick","family":"Berard","sequence":"additional","affiliation":[{"name":"Service Hospitalo\u2010Universitaire de Pharmaco\u2010Toxicologie, Hospices Civils de Lyon  Lyon France"},{"name":"University of Montreal, Faculty of Pharmacy Research Center, CHU Ste\u2010Justine  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Grenet","sequence":"additional","affiliation":[{"name":"Service Hospitalo\u2010Universitaire de Pharmaco\u2010Toxicologie, Hospices Civils de Lyon  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuelle","family":"Ripoche","sequence":"additional","affiliation":[{"name":"French National Agency for Medicines and Health Products Safety (ANSM)  Saint Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Cucherat","sequence":"additional","affiliation":[{"name":"Service Hospitalo\u2010Universitaire de Pharmaco\u2010Toxicologie, Hospices Civils de Lyon  Lyon France"},{"name":"CNRS\u2014Universit\u00e9 Lyon 1 UMR5558\u2014Laboratoire de Biom\u00e9trie &amp; biologie \u00e9volutive, D\u00e9partement de biostatistiques &amp; mod\u00e9lisation pour la sant\u00e9 et l'environnement\u2014Equipe Evaluation et mod\u00e9lisation des effets des m\u00e9dicaments  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Cottin","sequence":"additional","affiliation":[{"name":"Service Hospitalo\u2010Universitaire de Pharmaco\u2010Toxicologie, Hospices Civils de Lyon  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.22865"},{"issue":"1","key":"e_1_2_8_3_1","first-page":"13","article-title":"Ondansetron use in early pregnancy and the risk of congenital malformations \u2013 A register based nationwide cohort study","volume":"22","author":"Andersen J. 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