congenital CMV infection
Conditions
Brief summary
The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.
Detailed description
Imaging abnormalities indicative for vertical transmission assed on ultrasound two weekly and on MRI at 30w GA., Maternal safety assessed by blood analysis (hematology, liver function, kidney function) and clinically, Fetal safety assessed by ultrasound prenatally, blood analysis at birth on umbilical cord blood (hematology, liver function), postnatal urine sample, MRI postnatally, Long term effects: hearing assessment yearly until year 4 and neurodevelopmental follow-up at 1,2 and 5 years of age.
Interventions
DRUGValaciclovir Sandoz 500 mg filmomhulde tabletten
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally. | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging abnormalities indicative for vertical transmission assed on ultrasound two weekly and on MRI at 30w GA., Maternal safety assessed by blood analysis (hematology, liver function, kidney function) and clinically, Fetal safety assessed by ultrasound prenatally, blood analysis at birth on umbilical cord blood (hematology, liver function), postnatal urine sample, MRI postnatally, Long term effects: hearing assessment yearly until year 4 and neurodevelopmental follow-up at 1,2 and 5 years of age. | — |
Countries
Belgium
Outcome results
None listed