The study tested the hypothesis of exposure to noise during pregnancy being teratogenic. It included 1,475 Finnish mothers who had given birth to a malformed child (orofacial cleft or structural defect of the central nervous system, skeleton, or heart and great vessels) and 1,475 reference mothers. A special interview soon after delivery yielded the primary information on exposure. Of the 783 mothers who reported noise exposure in the first trimester, 370 were case mothers and 413 were referents. Hygienic assessment indicated that 102 case mothers and 103 referents had been exposed in the first trimester to a sound level of around 80 dB LAeq(8 h) or higher, the overall odds ratio being 1.0 (95% confidence interval 0.7-1.3). Adjustment for potential confounders by logistic regression methods gave similar results. There was no obvious trend suggesting a hazard when different exposure categories were considered.