Introduction The purpose of this study was to evaluate the association between maternal tobacco exposure and development of orofacial clefts (OFCs) in the child in a Pakistani population. Methods A case-control study was conducted at the Cleft Hospital and Bashir Hospital in Gujrat, Pakistan, from December 2015 to December 2016. All new cases of OFC at the Cleft Hospital were included. Patients at Bashir Hospital younger than 3 years and without congenital malformations were selected as control subjects. Risk factors associated with OFC were identified through bivariate analyses. Multiple logistic regression was then performed to calculate adjusted odds ratios (ORs) of developing OFC according to various risk factors. Results The study included 297 patients with OFC and 131 control subjects. Upon univariable analysis, the following were associated with OFC: maternal tobacco exposure (P
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