Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

Inclusion Criteria: * pregnant women (in vitro fertilization permitted) * \>= 18 years of age * primary HCMV infection at 5-26 weeks' gestation * \<= 6 weeks from presumed onset of infection * gestational age between 5-32 weeks' gestation * written informed consent Exclusion Criteria: * multiple pregnancy * history of HIV or HBV or HCV infection * known immunodeficiency or immunosuppression * congenital or acquired autoimmune disease * known intolerance to protein of human origin * known intolerance to immune globulin * history of adverse effects to vaccination * hypersensitivity to human immune globulin (pathological IgG or IgA deficiences) * renal failure * serious organic or psychiatric disease * lack of motivation to participate in the study * women unable to satisfy study requirements * women not willing or unable to provide written informed consent * women not willing to give consent to transmission of anonymised data