Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
- Conditions
- Congenital Cytomegalovirus Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT02351102
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally
- Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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) Valacyclovir 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)
- Primary Outcome Measures
Name Time Method CMV Polymerase Chain Reaction (PCR) in amniotic fluid minimum 21 weeks gestation 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
- Secondary Outcome Measures
Name Time Method Clinical evidence of symptomatic congenital CMV infection within 1 week after delivery laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth
Trial Locations
- Locations (1)
Helen Schneider Hospital for Women
🇮🇱Petah Tikva, Israel