A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection

This multicenter, double-blind trial evaluated the efficacy of CMV hyperimmune globulin in preventing congenital CMV infection among pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation. Participants were randomly assigned to receive monthly infusions of hyperimmune globulin or placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal/neonatal death. The trial was stopped early for futility, as no significant difference was observed in the primary outcome between the hyperimmune globulin (22.7%) and placebo (19.4%) groups (relative risk, 1.17; 95% CI, 0.80 to 1.72). Adverse outcomes, including fetal/neonatal death, preterm birth, and low birth weight, were numerically higher in the hyperimmune globulin group, though not statistically significant. The study concluded that hyperimmune globulin did not reduce the incidence of congenital CMV infection or perinatal death compared to placebo.

This multicenter, double-blind trial evaluated the efficacy of CMV hyperimmune globulin in preventing congenital CMV infection among pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation. Participants were randomly assigned to receive monthly infusions of hyperimmune globulin or placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal/neonatal death. The trial was stopped early for futility, as no significant difference was observed in the primary outcome between the hyperimmune globulin (22.7%) and placebo (19.4%) groups (relative risk, 1.17; 95% CI, 0.80 to 1.72). Adverse outcomes, including fetal/neonatal death, preterm birth, and low birth weight, were numerically higher in the hyperimmune globulin group, though not statistically significant. The study concluded that hyperimmune globulin did not reduce the incidence of congenital CMV infection or perinatal death compared to placebo.