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
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
491 participants
OBSERVATIONAL
2025-04-04
2026-04-04
Brief Summary
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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).
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Detailed Description
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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). We also aim to evaluate the dating of the maternal primary infection in weeks of amenorrhoea and additional tests given by the MyCMV tool compared with the reference method.
For the study, the medical information of patients for whom CMV serology including the search for CMV IgG and IgM antibodies is prescribed in the Necker-Enfants Malades or Paul Brousse hospitals, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known, will be reinterpreted with the MyCMV tool without consequences on the care of the patients.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients
Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades or Paul Brousse hospitals, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known.
Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed
The CMV serology results of the patients will have been previously interpreted as part of the care on the basis of the entire virological file according to the reference method.
These results will be reinterpreted using the MyCMV tool on the basis of the serology results performed (IgM, IgG, avidity), CMV PCR, the date of sampling and the date of the start of pregnancy (or last period). This reinterpretation by the tool will be carried out as part of the study and will not be communicated to the patient or to the doctor prescribing the virological analyses.
Interventions
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Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed
The CMV serology results of the patients will have been previously interpreted as part of the care on the basis of the entire virological file according to the reference method.
These results will be reinterpreted using the MyCMV tool on the basis of the serology results performed (IgM, IgG, avidity), CMV PCR, the date of sampling and the date of the start of pregnancy (or last period). This reinterpretation by the tool will be carried out as part of the study and will not be communicated to the patient or to the doctor prescribing the virological analyses.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marianne Leruez-Ville, M.D., PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Jacques Fourgeaud, Pharma.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Hôpital Paul Brousse
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP240966
Identifier Type: -
Identifier Source: org_study_id
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