[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569452":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":26,"locations":36,"responsibleParty":99,"collaborators":101,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":10,"enrollmentInfo":113,"targetDuration":10,"studyType":116,"phases":10,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients",null,"Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades, Paul Brousse hospitals, or the CHU Limoges, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known.",[13],"Other: Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"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.\n\nThese 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.",[9],[20,23],{"name":21,"affiliation":5,"role":22},"Marianne Leruez-Ville, M.D., PhD","STUDY_DIRECTOR",{"name":24,"affiliation":5,"role":25},"Jacques Fourgeaud, Pharma.D., PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Jacques Dr Fourgeaud, Pharma.D., PhD","CONTACT","0033144495611","jacques.fourgeaud@aphp.fr",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Hélène Morel","003171196346","helene.morel@aphp.fr",[37,61,79],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU de Limoges","RECRUITING","Limoges","87000","France","FR",{"type":45,"coordinates":46},"Point",[47,48],1.24759,45.83362,{"lat":48,"lon":47},[51,56,59],{"name":52,"role":29,"phone":53,"phoneExt":54,"email":55},"Sophie Alain, MD, PhD","0555056724","+33","sophie.alain@unilim.fr",{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},"Mafi Sarah","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":10,"phoneExt":10,"email":10},"Sébstien Hantz, M.D., PhD",{"facility":62,"status":39,"city":63,"state":10,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Hôpital Necker-Enfants Malades","Paris","75015",{"type":45,"coordinates":66},[67,68],2.3488,48.85341,{"lat":68,"lon":67},[71,73,77],{"name":72,"role":29,"phone":30,"phoneExt":10,"email":31},"Jacques Fourgeaud, Pharm.D., PhD",{"name":74,"role":29,"phone":75,"phoneExt":10,"email":76},"Yves Ville, M.D., PhD","0033171196482","yves.ville@aphp.fr",{"name":78,"role":58,"phone":10,"phoneExt":10,"email":10},"Nicolas Veyrenche, M.D.",{"facility":80,"status":39,"city":81,"state":10,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hôpital Paul Brousse","Villejuif","94804",{"type":45,"coordinates":84},[85,86],2.35992,48.7939,{"lat":86,"lon":85},[89,93,97],{"name":90,"role":29,"phone":91,"phoneExt":10,"email":92},"Coralie Kerestedjian Pallier, M.D., PhD","003345593342","coralie.pallier@aphp.fr",{"name":94,"role":29,"phone":95,"phoneExt":10,"email":96},"Christelle Vauloup-Fellous, M.D., PhD","003345593314","christelle.vauloup-fellous@aphp.fr",{"name":98,"role":58,"phone":10,"phoneExt":10,"email":10},"Vincent Portet-Sulla, M.D.",{"type":100,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[102],{"name":103,"class":6},"URC-CIC Paris Descartes Necker Cochin","100569452","evaluation-of-software-for-interpreting-virological-results-indicated-for-the-diagnosis-of-cytomegalovirus-cmv-infection-during-pregnancy-and-intended-for-health-professionals-100569452",false,"NCT06694428","Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals","MyCMV","Inclusion Criteria:\n\n* Pregnant woman\n* 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\n* And with positive anti-CMV IgM or in the grey zone of the technique\n* And for whom the date of start of pregnancy is known\n* And who does not object to the use of their data in the context of this research\n\nExclusion Criteria: NA","FEMALE","18 Years",{"count":114,"type":115},491,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe 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).",[119,120],"Cytomegalovirus Infections","Maternal Primary Cytomegalovirus Infection",[122,123,124,125],"Congenital cytomegalovirus (cCMV) infection","Maternal primary cytomegalovirus infection","Maternal Screening and Diagnosis","Decision-making algorithm","2026-06-04",{"date":128,"type":129},"2026-06-08","ACTUAL",{"date":131,"type":129},"2025-04-04",{"date":133,"type":115},"2027-04-04",{"name":5,"class":6},3]