CMV hyperimmune globulin during pregnancy does not lower ris
The administration of cytomegalovirus (CMV) hyperimmune globulin during pregnancy did not decrease the risk of congenital CMV infection or perinatal death among the offspring of women with primary CMV infection in pregnancy, reveals findings from a placebo-controlled, randomized trial.

Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae.

In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed.

A total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants who tested positive, 399 underwent randomization. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women in the group that received hyperimmune globulin and of 37 of 191 women in the placebo group.

- The death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group, preterm birth occurred in 12.2% and 8.3%, respectively, and birth weight below the 5th percentile occurred in 10.3% and 5.4%.

- One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion.

- Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.

Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks’ gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo.