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Breakthrough blood test could spare unborn babies from painful needle tests

NCT ID NCT03622892

Diagnosis Sponsor: University Hospital, Brest 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new way to diagnose cystic fibrosis in unborn babies using a simple blood sample from the mother. Instead of using a needle to take fluid from around the baby, researchers used advanced DNA sequencing to read the baby's genes from tiny bits of fetal DNA floating in the mother's blood. The study included 28 families who already knew their baby was at risk for cystic fibrosis. If this method proves reliable, it could make prenatal testing safer and less stressful for families.

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 lead to a safer, noninvasive way to diagnose cystic fibrosis in unborn babies, replacing risky invasive tests.
What could go wrong
This was a small, early-stage study with only 28 participants. The method may not be accurate enough for routine use and needs much larger validation.

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

28 people

The number who actually took part.

Started

Oct 2018

Finished

Sep 2022

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 at 25% risk of transmitting Cystic Fibrosis and asking for prenatal diagnosis for this indication in the pluridisciplinary centers of Brest, Nantes, Dijon or Rouen University Hospitals, France.

Ages

18 to 55 years

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: * Pregnancies at 25% risk of being affected by Cystic Fibrosis with previously identified pathogenic variants * Couple asking for invasive prenatal diagnosis * Pregnancy at 8 weeks of gestation or later Exclusion Criteria: * Couple not asking for prenatal diagnosis * No signed consent obtained

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

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

Cystic fibrosis

Contacts and locations

Locations

  • CH Saint Brieuc

    Saint-Brieuc, 22000, France

  • CHRU de Brest

    Brest, 29609, France

  • CHRU de Dijon

    Dijon, 21079, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Rennes

    Rennes, 35000, France

  • CHU de Rouen

    Rouen, 76031, France

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