Diseases [C] - Virus Diseases [C02]
Conditions
Brief summary
Primary endpoint: Negative CMV PCR (<500 IU/ml) in neonatal blood collected in the first day of life or in cord blood at termination of pregnancy
Detailed description
Secondary objectives: (step 2) The following are to be compared between the 2 arms: -Proportion of asymptomatic neonates -Overall growth -Proportion of long-term sequelae at 2 years -Tolerance of treatment for mothers, fetuses and neonates -Adherence to treatment -Evolution of ultrasound features between Day0 and Week 2, Week 4, and Week 6 of treatment -Changes in cerebral and placental features between Day 1st magnetic resonance imaging (MRI) within the first month of inclusion and 2nd MR
Interventions
DRUGPREVYMIS PLACEBO
DRUGVALACICLOVIR ARROW 500 mg
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Negative CMV PCR (<500 IU/ml) in neonatal blood collected in the first day of life or in cord blood at termination of pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: (step 2) The following are to be compared between the 2 arms: -Proportion of asymptomatic neonates -Overall growth -Proportion of long-term sequelae at 2 years -Tolerance of treatment for mothers, fetuses and neonates -Adherence to treatment -Evolution of ultrasound features between Day0 and Week 2, Week 4, and Week 6 of treatment -Changes in cerebral and placental features between Day 1st magnetic resonance imaging (MRI) within the first month of inclusion and 2nd MR | — |
Countries
France
Outcome results
None listed