Study on Valaciclovir to Prevent Congenital CMV Infection in Pregnant Women with First Trimester CMV Infections

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What is this study about?

This clinical trial is focused on studying congenital CMV infection, a condition caused by the cytomegalovirus that can be passed from a pregnant mother to her baby. The study is investigating the use of a medication called Valaciclovir, which is taken as a film-coated tablet. The purpose of the study is to explore how effective Valaciclovir is in preventing the transmission of CMV from mother to baby during pregnancy, specifically when the mother contracts the virus for the first time in the first trimester.

Participants in the study will take Valaciclovir orally. The study will monitor the health and safety of both the mother and the baby throughout the pregnancy and after birth. This includes regular check-ups using ultrasound and MRI scans to look for any signs of the virus being passed to the baby. Blood tests will also be conducted to ensure the safety of the mother and baby, checking important health indicators like liver and kidney function. After birth, the baby’s health will continue to be monitored, including hearing tests and developmental assessments up to five years of age.

The study aims to provide valuable information on whether Valaciclovir can help prevent the transmission of CMV during pregnancy, potentially offering a new way to protect babies from this infection. The trial is expected to continue until 2031, allowing researchers to gather comprehensive data on the long-term effects and benefits of using Valaciclovir in this context.

1 consent and enrollment

Provide voluntary written informed consent. This confirms understanding and agreement to participate in the study.

Ensure eligibility by being 18 years or older and having a confirmed first trimester primary CMV infection.

2 medication administration

Begin taking valaciclovir as prescribed. The medication is in the form of a 500 mg film-coated tablet.

Take the medication orally as directed by the study team. Follow the dosage and frequency instructions provided.

3 monitoring and assessments

Undergo regular monitoring to assess the rate of vertical transmission. This includes a CMV PCR test on amniotic fluid collected during an amniocentesis at 20 weeks of pregnancy.

Participate in imaging assessments, including ultrasounds every two weeks and an MRI at 30 weeks of gestational age.

4 safety evaluations

Maternal safety will be assessed through blood tests to check hematology, liver function, and kidney function.

Fetal safety will be evaluated through prenatal ultrasounds, blood analysis at birth on umbilical cord blood, and a postnatal urine sample.

5 postnatal assessments

After birth, a PCR test will be conducted on a urine sample to reconfirm the results of the amniocentesis.

An MRI will be performed postnatally to check for any abnormalities.

6 long-term follow-up

Hearing assessments will be conducted yearly until the child reaches four years of age.

Neurodevelopmental follow-up will occur at 1, 2, and 5 years of age to monitor the child’s development.

Who Can Join the Study?

The participant must provide voluntary written informed consent, which means they agree to join the study after understanding all the details.
The participant must be 18 years or older.
The participant must have a proven first trimester primary CMV infection. This means they have been diagnosed with a new CMV infection during the first three months of pregnancy.
The participant must be female.

Who Cannot Join the Study?

Patients who are not pregnant cannot participate.
Patients who are not in their first trimester of pregnancy cannot participate.
Patients who do not have a primary CMV infection during pregnancy cannot participate. CMV infection is a virus that can be passed from mother to baby during pregnancy.
Patients who are male cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Ziekenhuis Oost Limburg	Genk	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Uwdcgthdrv Oi Alshqon	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Valaciclovir

Valaciclovir is a medication used in this clinical trial to help prevent the transmission of a virus called CMV from a pregnant mother to her unborn baby. CMV is a common virus that can cause health problems for the baby if passed on during pregnancy. Valaciclovir works by stopping the virus from multiplying, which can reduce the chance of the baby getting infected. This study is looking at how well valaciclovir works when given to pregnant women who have a new CMV infection in the early stages of pregnancy.

Investigated diseases:

Cytomegalovirus infection

Congenital Cytomegalovirus Infection – Congenital cytomegalovirus infection occurs when a baby is infected with the cytomegalovirus (CMV) before birth. This virus is a common cause of infection in humans and can be transmitted from a pregnant woman to her fetus. The infection can affect the development of the baby, potentially leading to hearing loss, vision problems, or developmental delays. The virus can be present in the baby’s body without causing any symptoms at birth, but some infants may show signs such as jaundice, low birth weight, or an enlarged liver and spleen. Over time, the virus can continue to affect the child’s health, particularly their hearing and neurological development. Monitoring and follow-up are important to assess the long-term effects of the infection on the child’s growth and development.

Trial ID:

2022-500714-25-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Valaciclovir to Prevent Congenital CMV Infection in Pregnant Women with First Trimester CMV Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?