Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Sponsor
Rabin Medical Center
Study ID
NCT02351102
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Congenital Cytomegalovirus Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

Key Dates

Start date
Nov 30, 2015
Status verified
Jul 2019
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Valacyclovir
    Participants will receive Valacyclovir at a dose of 8g/d starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)
  • Placebo Comparator: Placebo
    Participants will receive placebo pills (same daily amount as the intervention group) starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)

Primary Outcome Measure

CMV Polymerase Chain Reaction (PCR) in amniotic fluid [ Time Frame: minimum 21 weeks gestation ]

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