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 range18 Years

SexFEMALE

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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…

What they're measuring

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

Timeframe: six months

Trial details

NCT IDNCT01037712

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-03