Background Currently, there is no effective intervention fora primary cytomegalovirus (CMV) infection during pregnancy.
Methods We studied pregnant women with a primary CMV infection.The therapy group comprised women whose amniotic fluid containedeither CMV or CMV DNA and who were offered intravenous CMV hyperimmuneglobulin at a dose of 200 U per kilogram of maternal weight.A prevention group, consisting of women with a recent primaryinfection before 21 weeks' gestation or who declined amniocentesis,was offered monthly hyperimmune globulin (100 U per kilogramintravenously).
Results In the therapy group, 31 women received hyperimmuneglobulin, only 1 (3 percent) of whom gave birth to an infantwith CMV disease (symptomatic at birth and handicapped at twoor more years of age), as compared with 7 of 14 women who didnot receive hyperimmune globulin (50 percent). Thus, hyperimmuneglobulin therapy was associated with a significantly lower riskof congenital CMV disease (adjusted odds ratio, 0.02; 95 percentconfidence interval, to 0.15; P<0.001). In the preventiongroup, 37 women received hyperimmune globulin, 6 (16 percent)of whom had infants with congenital CMV infection, as comparedwith 19 of 47 women (40 percent) who did not receive hyperimmuneglobulin. Thus, hyperimmune globulin therapy was associatedwith a significantly lower risk of congenital CMV infection(adjusted odds ratio, 0.32; 95 percent confidence interval,0.10 to 0.94; P=0.04). Hyperimmune globulin therapy significantly(P<0.001) increased CMV-specific IgG concentrations and avidityand decreased natural killer cells and HLA-DR+ cells and hadno adverse effects.
Conclusions Treatment of pregnant women with CMV-specific hyperimmuneglobulin is safe, and the findings of this nonrandomized studysuggest that it may be effective in the treatment and preventionof congenital CMV infection. A controlled trial of this agentmay now be appropriate.
Source Information
From the Departments of Pediatrics (G.N.) and Gynecological Sciences, Perinatology, and Child Health (G.N., R.L.), La Sapienza University, Rome; and the Department of Pediatrics and Biostatistics, Medical College of Virginia Campus, Virginia Commonwealth University, Richmond (S.P.A., A.M.B.).
Address reprint requests to Dr. Nigro at Via dei Villini 35, 00161 Rome, Italy, or at nigrogio{at}libero.it.
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