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New blood test could replace risky prenatal procedures

NCT ID NCT07469657

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests a new blood test that looks for severe genetic diseases in unborn babies using a sample from the mother. The test analyzes fetal DNA found in the mother's blood, which could avoid the need for invasive procedures like amniocentesis that carry a small risk of miscarriage. Researchers will compare the costs and benefits of this approach with current methods in 300 couples at risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood test using next-generation sequencing of fetal DNA
What this could lead to
If successful, this could offer a safer, earlier alternative to invasive prenatal testing for many genetic conditions, reducing the risk of miscarriage.
What could go wrong
This is a health economics study, not a treatment trial. It will assess costs and feasibility, not prove the test works for all conditions. The test may not be widely available or affordable.

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 300 people

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

Started

Mar 2026

Expected to finish

May 2029

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

Couples undergoing prenatal diagnosis are at high risk of transmitting a severe incurable condition due to a monogenic defect.

Ages

18 years and older

Sex

Anyone

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: * Couple aged over 18 years * Ongoing pregnancy of at least 7 weeks gestational age * Requesting, within clinical care, invasive prenatal diagnosis or PCR-based NIPD for a particularly severe monogenic disorder, with indication confirmed by a Multidisciplinary Prenatal Diagnosis Center (CPDPN) * Eligible for exclusion diagnosis * Causative gene covered by the Agilent V8 exome capture kit * Affiliated with the national general social security system * Informed consent obtained from the pregnant woman and her partner Exclusion Criteria: * Prenatal diagnosis request not approved by a Multidisciplinary Prenatal Diagnosis Center (CPDPN) * Disorder not analyzable by next-generation sequencing (e.g., triplet repeat expansions, sequence homology) * Woman carrying the pathogenic variant * Woman or partner deprived of liberty, under guardianship or curatorship * Index case other than the father, a child, or a fetus from a previous pregnancy within the couple.

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Conditions

The condition(s) this trial relates to.

hereditary disease

As listed by the trial registrant

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

Genetic diseases, inborn Monogenic diseases

How to take part

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

  1. The places running it

    1 site. 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

  • Hôpital Necker Enfants Malades

    RECRUITING

    Paris, Île-de-France Region, 75015, France

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