Maria Grazia Revello, Tiziana Lazzarotto, Brunella Guerra, Arsenio Spinillo, Enrico Ferrazzi, Alessandra Kustermann, Secondo Guaschino, Patrizia Vergani, Tullia Todros, Tiziana Frusca, Alessia Arossa, Milena Furione, Vanina Rognoni, Nicola Rizzo, Liliana Gabrielli, Catherine Klersy, Giuseppe Gerna
BACKGROUND: Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission, from 40% to 16%. METHODS: We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid...
April 3, 2014: New England Journal of Medicine