New study checks if CMV drug reaches fetus in second trimester
NCT ID NCT04732260
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug letermovir passes from a pregnant woman to her fetus during the second trimester. Seven women who were already scheduled to end their pregnancy for other reasons took part. The goal was to measure drug levels in fetal blood and amniotic fluid to see if they are high enough to fight cytomegalovirus (CMV). This is a first step toward possibly using letermovir to treat CMV infection during pregnancy.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
7 people
The number who actually took part.
- Started
-
Jun 2021
- Finished
-
Nov 2021
- 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
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Pregnant woman ≥ 18 years old * in her second trimester of pregnancy * undergoing TOP for any fetal abnormality * no evidence of placental dysfunction. * \- affiliation to a social security regime//health insurance * given consent for the study. * patient must be able and willing to comply with study visits and procedures Exclusion Criteria: * Participation to another interventional drug trial (category 1) * Subject protected by law under guardianship or curatorship * Woman with creatinine clearance \<75 ml/mn/1.73m2 * Woman with liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN. * Woman with known allergy to Letermovir * Contraindication for the administration of Letermovir listed in the SmPC of Prevymis® * Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatine or cyclosporine. * Concomitant administration of millepertuis * Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Congenital cytomegalovirus infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Hôpital Necker - Enfants malades
Paris, 75015, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New study: can we diagnose CMV in newborns who fail hearing tests within the first month?
- New study aims to catch hidden infection in babies with hearing loss
- MRI scans aim to uncover hidden ear damage in CMV survivors
- Could a new drug help babies with a common but dangerous birth infection?
- Could a common antiviral protect babies from CMV in the womb?
- New score could predict which CMV-Infected newborns will face hearing loss