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Congenital cytomegalovirus (CMV) infection is potentially devastating. Although nonrandomized studies have suggested benefit from hyperimmune globulin administered to pregnant women with primary CMV infection, no randomized trials had been done for verification. Now, researchers in Italy have conducted a phase II, double-blind, multicenter study to evaluate the efficacy of this agent.
Pregnant women with primary infection at 5 to 26 weeks of gestation and presumed onset within the previous 6 weeks were randomized to receive intravenous hyperimmune globulin (100 U/kg of body weight) or placebo (0.9% saline solution). Infusions were administered every 4 weeks until 36 weeks of gestation, detection of CMV in amniotic fluid, or spontaneous termi…