In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir (NCT01037712) | Clinical Trial Compass
TerminatedPhase 4
In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
Stopped: not enough inclusion
France6 participantsStarted 2009-09
Plain-language summary
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years,
* Fetal 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,
* 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:
* No 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,
* Patients whose fetus does not present any echographic sign being able to be in connection with the infection with CMV,
* Patients whose fetus presents at least one cerebral echographic anomaly:IntraparenchymalVentriculomegaly measured with the ventricular crossroads ≥ 12mm
* Hyperechogenicity periventricular
* Hydrocephaly
* Intra-ventricular adherence
* Microcephaly
* Increase cuts large retro-cerebellar cistern
* Hypoplasia vermis
* Intraparenchymal calcifications
* Porencephaly
* Lissencephaly
* Cysts periventricular
* Hypoplasia of the callous body
* S…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fetal infection with CMV) at 24 hours