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New blood test could replace risky amniocentesis for genetic disorders

NCT ID NCT03743948

Diagnosis Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new blood test that looks for fetal cells in the mother's blood to diagnose genetic diseases in the baby. It aimed to replace invasive tests like amniocentesis, which carry a small risk of miscarriage. The trial enrolled 18 pregnant women but was terminated early, so we don't yet know if the test works well enough.

What this could mean

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

What this could lead to
If successful, this could offer a safer, non-invasive way to diagnose genetic disorders in unborn babies, reducing the need for risky procedures like amniocentesis.
What could go wrong
The trial was terminated early with only 18 participants, so results are limited. The test may fail due to low fetal cell counts or technical issues, and it is not yet proven reliable.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Dec 2018

Finished

Aug 2019

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * older than 18 years old * pregnant woman between 9 and 34 weeks of gestation * Couple undergoing prenatal diagnosis for a monogenic disease caused by point mutation(s) * Written informed consent was obtained for the study * Prenatal diagnosis has been programmed for the current pregnancy during which maternal blood is collected * Couple molecular diagnosis results for a monogenic disease caused by point mutation(s) MUST BE AVAILABLE. Exclusion criteria: * Couple Genomic DNA are unavailable * Subjects at risk of transmitting the family disease, but not wishing to know their molecular status * Individuals under guardianship by court order

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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.

Monogenic diseases

Contacts and locations

Locations

  • INSERM-Hospital,

    Montpellier, Herault, 34295, France

More trials for these conditions

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