Evaluating a software tool for diagnosing CMV infection in pregnant women
Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
This study is testing a new software tool to help doctors quickly and accurately diagnose CMV infections in pregnant women to ensure timely treatment for the health of the baby.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 491 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06694428 on ClinicalTrials.gov |
What this trial studies
This study evaluates the MyCMV 'expert' tool, a decision-making algorithm designed to assist health professionals in interpreting serological results for cytomegalovirus (CMV) infections during pregnancy. The tool aims to streamline the diagnosis process, which can be complex and often leads to delays in treatment. By providing clearer interpretations of CMV serology and PCR results, the study seeks to improve the timely administration of secondary prevention measures, such as valaciclovir, to protect the fetus. The study is observational and involves pregnant women who have undergone CMV serology testing at designated hospitals.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have been prescribed CMV serology testing and have positive anti-CMV IgM or results in the grey zone.
Not a fit: Patients who are not pregnant or those who do not have a CMV serology test prescribed will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly reduce delays in diagnosing CMV infections in pregnant women, leading to better outcomes for both mothers and their babies.
How similar studies have performed: While the approach of using decision-making algorithms in medical diagnostics is gaining traction, this specific application for CMV infection during pregnancy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 1 other locations
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
- Hôpital Paul Brousse — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Jacques Fourgeaud, Pharma.D., PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Jacques Dr Fourgeaud, Pharma.D., PhD
- Email: jacques.fourgeaud@aphp.fr
- Phone: 0033144495611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.