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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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

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Congenital Cytomegalovirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Valacyclovir

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Valacyclovir

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes