Actively Recruiting
Evaluation of Software for Interpreting Virological Results for Diagnosing Cytomegalovirus (CMV) Infection During Pregnancy Intended for Health Professionals
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-06-08
491
Participants Needed
3
Research Sites
N/A
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 in Europe, affecting about 0.4% of births. It is a leading cause of sensorineural hearing loss and neurodevelopmental disabilities when transmitted from mother to fetus, especially if the mother has a primary infection during pregnancy. Diagnosing CMV infection can be complex and may delay treatment that could help prevent transmission to the fetus. This research aims to evaluate whether a new decision-making software, called the MyCMV tool, helps health professionals interpret test results more quickly and accurately to detect primary CMV infection early in pregnancy. The study involves reviewing the CMV serology results of pregnant women who have been tested for CMV antibodies at certain hospitals. These results will be reinterpreted using the MyCMV tool, which analyzes laboratory data and pregnancy timing to assist in diagnosis. This reinterpretation is done for research purposes only and will not affect the clinical care of the patients. The study compares the detection rate of CMV infection using the MyCMV tool with the current expert-based method. Participants in the study are pregnant women with positive or borderline CMV IgM antibody results and known pregnancy start dates. Their medical information will be used to evaluate how well the MyCMV tool estimates the timing of infection and suggests additional tests. The main outcome measured is the detection rate of primary CMV infection in the first trimester. The study does not involve any new treatments or interventions for participants and focuses on analyzing existing test data.
CONDITIONS
Brief 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, Paul Brousse hospital, or CHU Limoges
- Positive or borderline (grey zone) anti-CMV IgM antibody result
- Known date of start of pregnancy
- Does not object to use of her data for research purposes
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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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility based on CMV serology results and pregnancy date
Duration - At the time of serology result availability
Participants' previously collected CMV serology and PCR results are reinterpreted using the MyCMV tool to evaluate the detection of primary CMV infection and recommend additional analyses.
No additional visits; reinterpretation is done using existing data without direct participant involvement
Duration - Duration of pregnancy
Participants are observed through their routine pregnancy care without changes to their treatment or management based on the study interpretation.
Routine prenatal visits as per standard care
Trial Site Locations
Total: 3 locations
1
CHU de Limoges
Limoges, France, 87000
Actively Recruiting
2
Hôpital Necker-Enfants Malades
Paris, France, 75015
Actively Recruiting
3
Hôpital Paul Brousse
Villejuif, France, 94804
Actively Recruiting
Research Team
J
Jacques Dr Fourgeaud, Pharma.D., PhD
H
Hélène Morel
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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