Objective: to investigate the prevalence and risk factors in newborns with congenital heart defects (CHD).Methods: this case-control study included 234,386 births from January 2006 to June 2013 that were evaluated and registered in the Latin-American Collaborative Study of Congenital Malformations (ECLAMC) methodology, establishing the Bogota Birth Defects Surveillance and Follow-up Program (BBDSFP).Results: 234,368 births were registered and 277 of them were identified to have a CHD.The most common defect among all was ventricular septal defect (13.7%) followed by atrial septal defect (10.1%).As main associations we obtained: having any type of pre-gestational diabetes mellitus had an increased risk for the development of CHD (OR 16.36 CI: 4.54---58.35).Low weight newborns (less than 2,500 g) (OR: 4.13 CI: 3.13---5.44)and a gestational age lower than 36 weeks (OR: 4.92 CI: 3---5.44)were also linked to malformations.Conclusions: women with diabetes mellitus represent a high-risk pregnancy group, more work is needed to educate diabetic women, so CHD can be prevented and the outcomes of their pregnancy can be improved.Appropriate glycemic control before and during pregnancy may reduce CHD.