A population-based case-control teratological study of vaginal econazole treatment during pregnancy

To study human risk and benefit of vaginal econazole treatment during pregnancy.

Pair analysis of cases with congenital abnormalities and matched controls in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA), 1980-1996.

Of 38151 pregnant women who had newborn infants without any congenital abnormalities (control group), 122 (0.3%), of 22843 case pregnant women who had newborns or fetuses with congenital abnormalities, 68 (0.3%) used vaginal suppository of econazole (crude prevalence odds ratio (POR): 0.9, with 95% confidence interval (CI): 0.7-1.3). The matched case-control pair analysis did not indicate any teratogenic potential of econazole use during the second and third months of gestation, i.e. in the critical period for most major congenital abnormalities.

Treatment with econazole during pregnancy does not indicate any teratogenic risk to the fetus.