OBJECTIVE: To evaluate the incidence of carpal tunnel syndrome (CTS) in pregnancy through a validated and multiperspective assessment of CTS. METHODS: During 2000, the Italian CTS study group focussed on the occurrence of CTS in women during the final stages of pregnancy, enrolled in 7 Italian centers. In addition to the physician-centered and neurophysiologic traditional evaluations, we used a validated patient-oriented measurement to obtain more comprehensive and consistent data for severity of symptoms and functional impairment. RESULTS: In our study, CTS was clinically diagnosed in more than half of women (62%). Neurophysiological evaluation provided diagnosis of CTS in around half of women (43% were positive in one hand at least). Our study provides evidence, reported here for the first time, of a correlation between edema and neurophysiological picture. Similarly, our study provides a correlation between validated patient-oriented measurement and edema. Moreover, a significant correlation between a negative trend (subjectively assessed) and smoking and alcohol consumption was observed. CONCLUSIONS: Our observations confirm that the edema of the tissues in the carpal tunnel could induce a mechanical compression of the nerve. Moreover, our data suggest that smoking and alcohol consumption have a negative role in the evolution of the syndrome probably due to impairment of the microcirculation.