• Z Zhang, X Zhang, Y-Y Zhou, C-M Jiang, and H-Y Jiang.
• Department of Urology, College of Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
• BJOG. 2019 Dec 1; 126 (13): 1546-1552.

BackgroundOral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.ObjectivesTo evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.Search StrategyA systematic literature search was conducted to identify relevant studies published from inception until April 2019.Selection CriteriaRelevant English-language citations using the terms oral fluconazole and pregnancy in humans.Data CollectionTwo reviewers independently abstracted data and assessed study quality.Main ResultsOral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99-1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high-dose users (>150 mg) (OR 1. 19, 95% CI 1.01-1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09-1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1-1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71-6.74, P < 0.001; n = 2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR 1.99, 95% CI 1.38-2.88, P < 0.001; n = 3).ConclusionsOral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven.Tweetable AbstractOral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.© 2019 Royal College of Obstetricians and Gynaecologists.

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