Clinical trial Recruiting at 3 sites Observational Ages 18 and up Women only

Evaluating a software tool for diagnosing CMV infection in pregnant women

Official title: Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals

Run by Assistance Publique - Hôpitaux de Paris · NCT06694428 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment491 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations3 sites (Limoges and 2 other locations)
StatusRecruiting
StartedApril 4, 2025
Main results expectedApril 4, 2027
Study endsApril 4, 2027
Registry record updatedJune 8, 2026
Trial IDNCT06694428 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 or CHU Limoges
* 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 it's running

  • CHU de Limoges
    Limoges, France
    Recruiting
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.