Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04732260
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04732260
Study Brief:
Protocol Section:
NCT04732260