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New software could speed up CMV diagnosis in pregnant women

NCT ID NCT06694428

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a decision-support tool called MyCMV that helps doctors interpret blood test results for cytomegalovirus (CMV) infection during pregnancy. CMV is a common virus that can cause hearing loss and developmental problems in babies if the mother catches it for the first time while pregnant. The tool aims to speed up diagnosis so that treatment can start earlier. About 491 pregnant women with positive or borderline CMV test results will take part, and the tool's accuracy will be compared to expert interpretation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 491 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades or Paul Brousse hospitals or 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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection disease Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cytomegalovirus infections Maternal primary cytomegalovirus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Limoges

    RECRUITING

    Limoges, 87000, France

  • Hôpital Necker-Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Hôpital Paul Brousse

    RECRUITING

    Villejuif, 94804, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.