Aim: To assess the incidence of cleft lip and palate and factors associated with them in the hospital births of Iran’s Kurdistan province in 2010. Methods: Researcher-completed questionnaires captured data on gender, mother’s age during pregnancy, parents’ occupation, father’s birthplace, family background, consanguinity, systemic diseases, mother’s disease during pregnancy, drugs abuse, smoking, alcohol drinking, radiography and mother’s radiotherapy during pregnancy. Results: Of 26,537 newborns, 29 (19 male and 10 females) were affected by various types of cleft lip and palate. Of newborns with cleft lip and palate: 38% had other abnormalities, consanguinity was reported in about 31% of cases and 28% of mothers used prescribed drugs during pregnancy while no mothers used cigarettes or alcohol. There was no report of radiotherapy or radiography. Conclusions: The incidence rate of oral clefts was 1.09 in the 1,000 live births. Key words: cleft lip, cleft palate, etiologic factors, incidence, oral clefts