title: Passive immunization during pregnancy for congenital cytomegalovirus infection.
abstract: BACKGROUND
  Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy.
  
  
  METHODS
  We studied pregnant women with a primary CMV infection. The therapy group comprised women whose amniotic fluid contained either CMV or CMV DNA and who were offered intravenous CMV hyperimmune globulin at a dose of 200 U per kilogram of maternal weight. A prevention group, consisting of women with a recent primary infection before 21 weeks' gestation or who declined amniocentesis, was offered monthly hyperimmune globulin (100 U per kilogram intravenously).
  
  
  RESULTS
  In the therapy group, 31 women received hyperimmune globulin, only 1 (3 percent) of whom gave birth to an infant with CMV disease (symptomatic at birth and handicapped at two or more years of age), as compared with 7 of 14 women who did not receive hyperimmune globulin (50 percent). Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV disease (adjusted odds ratio, 0.02; 95 percent confidence interval, -infinity to 0.15; P<0.001). In the prevention group, 37 women received hyperimmune globulin, 6 (16 percent) of whom had infants with congenital CMV infection, as compared with 19 of 47 women (40 percent) who did not receive hyperimmune globulin. Thus, hyperimmune globulin therapy was associated with 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 avidity and decreased natural killer cells and HLA-DR+ cells and had no adverse effects.
  
  
  CONCLUSIONS
  Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.
authors.affiliation: Department of Pediatrics, La Sapienza University, Rome. nigrogio@libero.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Nigro
authors.forename: Stuart P
authors.initials: SP
authors.lastname: Adler
authors.forename: Renato
authors.initials: R
authors.lastname: La Torre
authors.forename: Al M
authors.initials: AM
authors.lastname: Best
mesh_terms: D000328:Adult; D000653:Amniotic Fluid / Q000821:virology; D000704:Analysis of Variance; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000151:congenital / Q000517:prevention & control / Q000628:therapy*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005315:Fetal Diseases / Q000517:prevention & control / Q000628:therapy*; D006684:HLA-DR Antigens; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D007231:Infant, Newborn; D007694:Killer Cells, Natural; D016015:Logistic Models; D018655:Lymphocyte Count; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000628:therapy*; D011446:Prospective Studies
chemical_list: D004279:DNA, Viral; D006684:HLA-DR Antigens; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin