Abstract Objective To examine the risk of congenital malformations associated with exposure to oral fluconazole at commonly used doses in the first trimester of pregnancy for the treatment of vulvovaginal candidiasis. Design Population based cohort study. Setting A cohort of pregnancies publicly insured in the United States, with data from the nationwide Medicaid Analytic eXtract 2000-14. Participants Pregnancies of women enrolled in Medicaid from three or more months before the last menstrual period to one month after delivery, and infants enrolled for three or more months after birth. Interventions Use of fluconazole and topical azoles was established by requiring one or more prescriptions during the first trimester of pregnancy. Main outcome measures Risk of musculoskeletal malformations, conotruncal malformations, and oral clefts (primary outcomes), associated with exposure to oral fluconazole, diagnosed during the first 90 days after delivery, were examined.


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Citation Zhu YanminBateman Brian TGray Kathryn JHernandez-Diaz SoniaMogun HelenStraub Loreen et al. Oral fluconazole use in the first trimester and risk of congenital malformations: population based cohort study