Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

NCT06694428 | Recruiting

• 1 other identifier: APHP240966
• Study Type: observational
• Target: 491
• Locations: 1 country
• Sites: 2

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).

Conditions

Cytomegalovirus Infections; Maternal Primary Cytomegalovirus Infection

Keywords

Congenital cytomegalovirus (cCMV) infection; Maternal primary cytomegalovirus infection; Maternal Screening and Diagnosis; Decision-making algorithm

Outcome Measures

Primary Outcomes (1)

• Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool

  Detection of primary CMV infection in the first trimester of pregnancy by the MyCMV tool or by the reference method. In the context of this study, the reference method is the interpretation of the results by the expert investigator of the center, without using the MyCMV tool.

  Time 0

Secondary Outcomes (2)

• Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method

  Time 0

• Recommendations for the conduct to be adopted for carrying out additional analysis by the MyCMV tool

  Time 0

Study Arms (1)

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.

Other: Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed

Interventions

Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed OTHER

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Hôpital Paul Brousse

Villejuif, 94804, France

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Infections; Disease

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Leruez-Ville, M.D., PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Jacques Fourgeaud, Pharma.D., PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Dr Fourgeaud, Pharma.D., PhD

CONTACT

0033144495611; jacques.fourgeaud@aphp.fr

Hélène Morel

CONTACT

003171196346; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: April 4, 2025
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)