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- Anick Bérard, Odile Sheehy, Jessica Gorgui, Jin-Ping Zhao, Soares de Moura Cristiano C Faculty of Medicine, Department of Clinical Epidemiology, McGill University, Purvis Hall 1020 Pine Ave. West, Montréal, Québec H3A 1A2, Canada, and Sasha Bernatsky.
- Research Center, CHU Sainte-Justine, 3175, Chemin de la Côte-Sainte-Catherine, Montréal, Québec H3T 1C5, Canada; Faculty of Pharmacy, University of Montreal, Pavillon Jean-Coutu, 2940, chemin de Polytechnique, Montréal, Québec H3T 1J4, Canada. Electronic address: anick.berard@umontreal.ca.
- J Clin Epidemiol. 2019 Dec 1; 116: 39-48.
ObjectivesThe aim of the study was to quantify the risk of major congenital malformations (MCM) associated with first-trimester exposure to antiemetics.Study Design And SettingUsing the Quebec Pregnancy Cohort (1998-2015), first-trimester doxylamine-pyridoxine, metoclopramide, and ondansetron exposures were assessed for their association with MCM. Generalized estimating equations were used to estimate odds ratios (OR), adjusting for potential confounders (aOR).ResultsWithin 17 years of follow-up, the prevalence of antiemetic use during pregnancy increased by 76%. Within our cohort, 45,623 pregnancies were exposed to doxylamine-pyridoxine, 958 to metoclopramide, and 31 to ondansetron. Doxylamine-pyridoxine and metoclopramide use were associated with an increased risk of overall MCM (aOR 1.07, 95% confidence interval [CI]: 1.03-1.11; 3,945 exposed cases) and (aOR 1.27, 95% CI: 1.03-1.57; 105 exposed cases), respectively. Doxylamine-pyridoxine exposure was associated with increased risks of spina bifida (aOR 1.87, 95% CI: 1.11-3.14; 23 exposed cases), nervous system (aOR 1.25, 95% CI: 1.06-1.47; 225 exposed cases), and musculoskeletal system defects (aOR 1.08, 95% CI: 1.02-1.14; 1,735 exposed cases). Metoclopramide exposure was associated with an increased risk of genital organ defects (aOR 2.26, 95% CI: 1.14-4.48; 10 exposed cases). No statistically significant association was found between ondansetron exposure and the risk of overall MCM.ConclusionFirst-trimester doxylamine-pyridoxine and metoclopramide exposure was associated with a significantly increased risk of overall and specific MCM.Copyright © 2019. Published by Elsevier Inc.
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