Actively Recruiting
Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12
491
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman
- CMV serology including IgG and IgM antibodies prescribed at Necker-Enfants Malades or Paul Brousse hospital
- Positive or borderline anti-CMV IgM antibody test result
- Known start date of pregnancy
- Does not object to the use of their data for this research
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hôpital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
2
Hôpital Paul Brousse
Villejuif, France, 94804
Actively Recruiting
Research Team
J
Jacques Dr Fourgeaud, Pharma.D., PhD
CONTACT
H
Hélène Morel
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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