If you are included in this current study, there is a 50% chance you will receive a placebo, because although HIG is promising, it is still unproven.
I received the following e-mail from the Study Chair for a 14-center NICHD Maternal Fetal Medicine Units Network (MFMU) randomized clinical trial testing the efficacy and effectiveness of hyperimmune globulin for prevention of congenital CMV in women with primary infection:
Cytomegalovirus (CMV) is the most common congenital infection, with a prevalence of approximately 1% in the United States, translating into 44,000 congenitally infected infants per year. A substantial proportion of these 44,000 infants will die or suffer permanent injury as a result of their infection. The severity of congenital infection is greatest with primary maternal CMV infection.
Currently, there is no proven method of preventing congenital CMV infection, and the approach to primary maternal CMV infection in the United States is haphazard and ineffective. One small, non-randomized study suggests that maternal administration of CMV hyperimmune globulin may reduce the rate of congenital CMV infection following maternal primary infection.
To learn more about the current study, visit: http://clinicaltrials.gov/ct2/show/NCT01376778?term=congenital+cmv&rank=4
Brenna Anderson, M.D., M.Sc.
Women & Infants Hospital of RI
101 Dudley Street
Providence, RI 02905
401-274-1122 ext. 7456