Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
- Conditions
- Cytomegalovirus InfectionsMaternal Primary Cytomegalovirus Infection
- Registration Number
- NCT06694428
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 491
- 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
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool Time 0 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.
- Secondary Outcome Measures
Name Time Method Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method Time 0 Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method.
In case of seroconversion of IgG or the presence of isolated IgM (followed by seroconversion in a subsequent serum) in the patient's previous results, evaluation of the dating in weeks of amenorrhea given by the MyCMV tool compared to the dating obtained by the reference method.Recommendations for the conduct to be adopted for carrying out additional analysis by the MyCMV tool Time 0 Among the cases where it is not possible to conclude as to the occurrence of a primary infection during pregnancy on the basis of the available results, identification of the course of action to be taken for carrying out the additional analysis (on a previous sample, the same sample or a new sample) proposed by the reference method and the MyCMV tool.
Trial Locations
- Locations (2)
H么pital Necker-Enfants Malades
馃嚝馃嚪Paris, France
H么pital Paul Brousse
馃嚝馃嚪Villejuif, France