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.
A randomized, double-blind, placebo-controlled study. Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Helen Schneider Hospital for Women
Petah Tikva, Israel
CMV Polymerase Chain Reaction (PCR) in amniotic fluid
amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation
Time frame: minimum 21 weeks gestation
Clinical evidence of symptomatic congenital CMV infection
laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth
Time frame: within 1 week after delivery
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