TBM (Applied Biomedical Research with a Primary Societal finality) project: Prenatal valaciclovir-treatment for congenital CMV: a prospective cohort study

Patient: During pregnancy, a maternal cytomegalovirus (CMV) infection,
usually asymptomatic, might be transmitted to the fetus, known as
congenital or cCMV infection. In industrialized countries cCMV has an
estimated prevalence of 0.7% - 1.5% and can occur as a primary
infection or a non-primary infection (reinfection or re-activation). This
makes the disease more prevalent than Down’s syndrome, spina bifida
or fetal alcohol syndrome. Newborns with cCMV infection have 15-20%
risk to develop long-term sequela such has sensorineural hearing loss or
neurodevelopmental disabilities. Severe neurodevelopmental problems
result from first trimester infections, while second and third trimester
infections usually only result in (unilateral) hearing impairment without
severe long-term neurolodevelopmental morbidity.
Intervention: This study aims to investigate the effectivity of valaciclovir
to prevent CMV transmission to the fetus. Secondly we want to
investigate the long-term safety of valaciclovir treatment during
pregnancy. Patients with a proven first trimester primary CMV infection
will be treated with Valaciclovir 8g/d from the moment of diagnosis until
gestation week 20, the moment of amniocentesis.
Comparison: The number of fetal CMV infections will be compared to
historical data on the transmission rate collected in Flanders.
Outcome: The primary outcome measure is the rate of fetal infection in
women with a proven primary first trimester CMV infection at the time
of amniocentesis and at birth. Secondary outcomes include: imaging
abnormalities, hearing assessed annually and long term
neurodevelopmental outcome at 1, 2 and 5 years of age.