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Table 3 Major congenital anomalies in infants exposed to varenicline in the first trimester and matched comparison group. Data presented are numbers (percentage) of outcomes and hazard ratios (95% confidence interval)

From: Use of smoking cessation pharmacotherapies during pregnancy is not associated with increased risk of adverse pregnancy outcomes: a population-based cohort study

 Varenicline, 1st trimesterUnexposedHazard ratio (95% CI)
Any major congenital anomaly20 (2.9%)242 (3.5%)0.91 (0.72–1.15)
 Genitourinary7 (1.0%)67 (1.0%)1.00 (0.67–1.51)
 Cardiovascular6 (0.9%)52 (0.7%)1.16 (0.75–1.79)
 Musculoskeletal< 557 (0.8%)
 Gastrointestinal< 528 (0.4%)
 Nevers< 518 (0.3%)
 Respiratory< 56 (0.1%)
 Eyes< 511 (0.2%)
 Face, neck0< 5
 Integumentary0< 5
 Genetic syndromes< 57 (0.1%)
 Situs inversus0< 5
 Others< 59 (0.1%)
  1. Hazard ratio was obtained from the univariate model