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Could a common antiviral protect babies from CMV in the womb?

NCT ID NCT01651585

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether giving the antiviral drug valacyclovir to pregnant women with a CMV-infected fetus could reduce the chance of the baby being born with serious symptoms. 41 pregnant women took high doses of valacyclovir daily for up to 23 weeks. The goal was to see if the drug could lower the virus level in the baby and improve outcomes at birth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
valacyclovir
What this could lead to
If successful, this could point toward a way to reduce the severity of congenital CMV infection in newborns.
What could go wrong
This was a small, non-randomized trial with 41 participants, so results may not apply broadly. The drug may not prevent all complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

41 people

The number who actually took part.

Start date

Jul 2011

Finished

Jul 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Age ≥ 18 years, * Fœtal Infection with CMV authenticated by the positivity of the research of the viral genome by PCR in the amniotic liquid, * Echographic Assessment revealing at least one cerebral extra anomaly being able to be in connection with the infection with CMV, * And/or one isolated cerebral anomaly : * Ventriculomégalie measured with the ventricular crossroads \< 15mm * Signs of lenticulo-striated vasculopathy * Intraparenchymateuses calcifications * Intra-ventricular adherences * And/or biological signs of generilazed infection to CMV : * fetal viremia \> 3000 copies/ml * platelet \< 100 000/cc * Absence of request for termination of pregnancy from the start, * Acceptance of a strict follow-up by a Multi-field Center of Prenatal diagnosis and of an optimal observance of the founded treatment, * Collection of the written assent to take part in the test. * Affiliation with a mode of social security or equivalent. Exclusion criteria : * Not affiliation with a mode of social security (profit or having right) * Patient of less than 18 years, * Patient presenting another pathology obstetrical or medical (in particular hepatic or renal) preexistent to tracking or contra-indicating the use of valacyclovir, * Patientes whose fœtus does not present any echographic sign being able to be in connection with the infection with CMV, * Patientes whose fœtus presents at least one cerebral echographic anomaly : Ventriculomégalie measured with the ventricular crossroads ≥ 15mm Hyperechogenicity periventriculaire Hydrocephaly Microcephaly Increase cuts large retro-cérébelleuse cistern Hypoplasy vermienne Porencephaly Lissencephaly Cysts périventriculaires Hypoplasy of the callous body * Patient under any other active antiviral treatment against CMV, * Patient taking part in another therapeutic test, * Patient refusing to sign the enlightened assent, * Patient formulating a request for medical interruption of pregnancy before inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Necker Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.