Clinical trial NCT06694428: Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
Official title: Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus Infections
Maternal Primary Cytomegalovirus Infection
Keywords: Congenital cytomegalovirus (cCMV) infection
Maternal primary cytomegalovirus infection
Maternal Screening and Diagnosis
Decision-making algorithm
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 491
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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).

Detailed description: 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). 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.

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
* 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

Primary outcomes:
measure: Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool
timeFrame: Time 0
Secondary outcomes:
measure: Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method
timeFrame: Time 0
measure: Recommendations for the conduct to be adopted for carrying out additional analysis by the MyCMV tool
timeFrame: Time 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marianne Leruez-Ville, M.D., PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jacques Fourgeaud, Pharma.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: