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