NCT02351102

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Cytomegalovirus Infection

Interventions

Type	Name	Description
DRUG	Valacyclovir
DRUG	Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2015-01-30
• Last updated: 2019-07-16

Locations

1 site across 1 country: Israel