NCT06694428 Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
| NCT ID | NCT06694428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cytomegalovirus Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 491 participants |
| Start Date | 2025-04-04 |
| Primary Completion | 2027-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 491 participants in total. It began in 2025-04-04 with a primary completion date of 2027-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty. The diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection. The National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV "expert" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results. The hypothesis of the study is that the use and provision of this MyCMV "expert" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection. The aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator).
Eligibility Criteria
Inclusion Criteria: * Pregnant woman * And for whom a CMV serology including the search for CMV IgG and IgM antibodies is prescribed at the Necker-Enfants Malades or Paul Brousse hospital or CHU Limoges * And with positive anti-CMV IgM or in the grey zone of the technique * And for whom the date of start of pregnancy is known * And who does not object to the use of their data in the context of this research Exclusion Criteria: NA
Contact & Investigator
Marianne Leruez-Ville, M.D., PhD
STUDY DIRECTOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06694428 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06694428 currently recruiting?
Yes, NCT06694428 is actively recruiting participants. Contact the research team at jacques.fourgeaud@aphp.fr for enrollment information.
Where is the NCT06694428 trial being conducted?
This trial is being conducted at Limoges, France, Paris, France, Villejuif, France.
Who is sponsoring the NCT06694428 clinical trial?
NCT06694428 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marianne Leruez-Ville, M.D., PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 491 participants.