Hyperimmune globulin doesn’t prevent congenital CMV

A randomized controlled trial (RCT) calls into question the benefit of administering hyperimmune globulin to pregnant women with primary cytomegalovirus infection (CMV) as a way to prevent intrauterine transmission. CMV is a major cause of morbidity and mortality.

Published in The New England Journal of Medicine, the Phase II study by Italian researchers included 123 pregnant women with CMV infection at 5 to 26 weeks’ gestation. Randomization-done within 6 weeks after presume onset of infection-was to hyperimmune globulin or placebo every 4 weeks until 36 weeks’ gestation or detection of CMV in amniotic fluid.

Congenital infection diagnosed at birth or via amniocentesis was the primary end point. In the group given hyperimmune globulin, the rate of congenital infection was 30% (18 fetuses or infants of 61 women) versus 44% (27 fetuses or infants of 62 women) for placebo (95% confidence interval, -3 to 31; P=0.13). No significant differences were seen between the two groups in levels of virus-specific antibodies, T-cell-mediated immune response, or viral DNA in the blood. Clinical outcome of congenital infection at birth was similar in the two groups but the hyperimmune globulin group had more obstetrical adverse events than did the placebo group (13% vs. 2%).

Treatment with hyperimmune globulin, the researchers concluded, did not significantly modify the course of primary CMV during pregnancy.

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