A trial of immunoglobulin fetal therapy for symptomatic congenital cytomegalovirus infection.

No medical intervention guideline for prenatally diagnosed symptomatic congenital cytomegalovirus infection (CCMVI) is currently available. The aim of the study was to assess the efficacy of immunoglobulin fetal therapy for symptomatic CCMVI. With informed consent, hyper-immunoglobulin was injected into the peritoneal cavity of affected fetuses or into the maternal blood in 12 women who had symptomatic CCMVI. After immunoglobulin therapy, ultrasound examinations demonstrated the following changes: Ascites disappearance 57.1% (4/7) and a decrease in ascites volume 14.3% (1/7); improvement in intrauterine growth restriction 54.5% (6/11); disappearance of mild ventriculomegaly 40% (2/5); and in one case hepatomegaly and hydronephrosis disappeared. The survival rate of affected infants was found to be 83.3% (10/12). Concerning morbidity, 25.0% (3/12) of the infants developed normally. An additional two cases had only unilateral hearing difficulty without other sequelae. Therefore, 41.7% (5/12) of symptomatic CCMVI infants whose mothers received prenatal immunoglobulin therapies had no or only minimal sequelae (unilateral hearing difficulty). No direct adverse effects were observed. Immunoglobulin therapy may be effective for symptomatic CCMVI, reducing the incidence and severity of sequelae. To confirm the efficacy, a randomized study should be further performed.