HealthDay News — Administration of cytomegalovirus (CMV) hyperimmune globulin vs placebo to women with primary CMV infection in early pregnancy does not result in a lower incidence of congenital CMV infection or perinatal death in their offspring, according to a study published in the July 29 issue of the New England Journal of Medicine.

Brenna L. Hughes, MD, from Brown University in Providence, Rhode Island, and colleagues conducted a multicenter, double-blind trial, involving pregnant women with primary CMV infection diagnosed before 24 weeks of gestation. A total of 399 women were randomly assigned to receive either a monthly infusion of CMV hyperimmune globulin or matching placebo until delivery.

The trial was stopped early for futility. The researchers found that a primary outcome event occurred in the fetus or neonate of 22.7 and 19.4% of women who received hyperimmune globulin and placebo, respectively (relative risk, 1.17; 95% CI, 0.80 to 1.72; P =.42). No significant differences were seen in rates of death (4.9 and 2.6% of fetuses or neonates in the hyperimmune globulin and placebo groups, respectively; relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth (12.2 and 8.3%; relative risk, 1.47; 95% CI, 0.81 to 2.67), or birthweight below the fifth percentile (10.3 and 5.4%; relative risk, 1.92; 95% CI, 0.92 to 3.99).

“These findings contradict the conclusions of observational studies that suggested significant improvement in outcomes with the administration of CMV hyperimmune globulin,” the authors write.


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CSL Behring provided the Cytogam and AlbuRx used in this trial.

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