Fig. 1.

Overview of the study design. Participation in the study was restricted to adult (> 18 years of age) Italian pregnant women undergoing serum screening for fetal aneuploidy at 11–12 weeks of gestation and at risk for CMV infection. Interpretation of IgM-positive results and prenatal or neonatal diagnosis of congenital CMV infection in case of maternal seroconversion or primary infection in the first trimester of gestation were performed outside of the present study as part of routine care in case of suspected or confirmed primary CMV infection (dotted boxes).