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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02351102

Enrollment

100

Registered

2015-01-30

Start date

2015-11-30

Completion date

2019-07-31

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cytomegalovirus Infection

Keywords

Congenital CMV, Congenital Cytomegalovirus

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.

Interventions

DRUGValacyclovir

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Clinical evidence of symptomatic congenital CMV infection	within 1 week after delivery	laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026