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Objective:To assess the prevalence of cigarette smoking in pregnancy, and the rate of congenital malformations in children at in utero exposure.Methods:The trial was designed as a cross-sectional study to measure exposure of pregnant women to adverse influence of smoking and their health status.The study consists of two arms: one was conducted at fourZagreb matity hospitals(Croatia) and the other at the same hospitals inNoviSad(Serbia).Results:Data analysis revealed the habit of cigarette smoking during pregnancy in829(11.9%) of6992(6099+893) women.Malformations were found in105(1.5%) fetuses and newbs.Major congenital malformations were present in4(0.6%), minor malformations in73(10.5%) and low birth weight in12(1.7%) newbs.In all these pregnant women smoked until becoming aware of pregnancy or during pregnancy.Tobacco smoking and congenital abnormalities that define the contingency table were not significantly related inZagreb(P=0.385), as well as inNoviSad(P=0.345). Conclusions:The proportion of pregnant women reporting cigarette smoking was quite similar in Zagreb andNoviSad.There is no statistically significant association between cigarette smoking and congenitalmalformations.