Consensus Consensus (Rawlinson et al — — — Cytomegalovirus hyperimmunoglobulin recommendation 2017) should not be routinely administered to pregnant women with primary cytomegalovirus infection to prevent fetal cytomegalovirus infection. Cytomegalovirus hyperimmunoglobulin treatment should not be routinely administered for fetal cytomegalovirus infection. SLR IV 4 Aim: To identify evidence-based interventions Treatment of maternal CMV infection with Included (Hamilton et al (Revello for prevention of congenital CMV at the primary hyperimmune globulin (HIG) showed some and 2014) et al 2014) level (prevention of maternal infection), evidence for efficacy in prevention of fetal (Nigro et al 2015) secondary level (risk reduction of fetal infection and fetal/neonatal morbidity with a 6 infection and disease) and tertiary level (risk reasonable safety profile. However, more reduction of infected neonates being affected robust clinical evidence is required before HIG by CMV). therapy can be routinely recommended. RCT II 123 Aim: To evaluate the efficacy of CMV-specific The rate of congenital infection was 30% in the (Revello et al hyperimmune globulin in reducing intrauterine hyperimmune globulin and 44% in the 2014) transmission. placebo group (a difference of 14 percentage points; 95%CI -3 to 31; P=0.13). The clinical Population: Pregnant women with primary CMV outcome of congenital infection at birth was infection at 5 to 26 weeks of gestation. similar in the two groups. Methods: Women were randomly assigned The number of obstetrical adverse events was within 6 weeks after the presumed onset of higher in the hyperimmune globulin group than infection to receive hyperimmune globulin or in the placebo group (13% vs. 2%). placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary endpoint was congenital infection diagnosed at birth or by means of amniocentesis.
(Rawlinson et al 2017) Consensus — — — Cytomegalovirus hyperimmunoglobulin should not be routinely administered to pregnant women with primary cytomegalovirus infection to prevent fetal cytomegalovirus infection. Cytomegalovirus hyperimmunoglobulin treatment should not be routinely administered for fetal cytomegalovirus infection. Consensus recommendation (Hamilton et al 2014) SLR IV 4 6 Aim: To identify evidence-based interventions for prevention of congenital CMV at the primary level (prevention of maternal infection), secondary level (risk reduction of fetal infection and disease) and tertiary level (risk reduction of infected neonates being affected by CMV). Treatment of maternal CMV infection with hyperimmune globulin (HIG) showed some evidence for efficacy in prevention of fetal infection and fetal/neonatal morbidity with a reasonable safety profile. However, more robust clinical evidence is required before HIG therapy can be routinely recommended. Included (Revello et al 2014) and (Nigro et al 2015) (Revello et al 2014) RCT II 123 Aim: To evaluate the efficacy of CMV-specific hyperimmune globulin in reducing intrauterine transmission. Population: Pregnant women with primary CMV infection at 5 to 26 weeks of gestation. Methods: Women were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary endpoint was congenital infection diagnosed at birth or by means of amniocentesis. The rate of congenital infection was 30% in the hyperimmune globulin and 44% in the placebo group (a difference of 14 percentage points; 95%CI -3 to 31; P=0.13). The clinical outcome of congenital infection at birth was similar in the two groups. The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group (13% vs. 2%).
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