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New blood test could spot fetal chromosomal issues earlier and more accurately

NCT ID NCT03375359

Diagnosis Sponsor: University Hospital Tuebingen Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 cell-free DNA blood test to screen for trisomy 21, 18, 13 and 22q11.2 deletion in over 1,100 pregnant women during the first trimester. The goal was to see how accurate the test is compared to standard combined screening. Researchers measured how often the test gave a positive result, a false positive, or no result at all.

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 improve early detection of chromosomal abnormalities in pregnancy, reducing false positives and unnecessary invasive tests.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. Results may not apply to all populations or screening settings.

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

1,127 people

The number who actually took part.

Started

Jan 2018

Finished

Dec 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.

Who is studied

Pregnant women who are referred for FTS or for further follow-up examinations in case of a suspected anomaly or increased nuchal translucency at 11-13 weeks' gestation

Ages

18 years and older

Sex

Female participants only

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: * Maternal age of 18 years and more * Crown rump length 45 - 84mm * Referral for first trimester risk assessment * Singleton pregnancy * Written consent Exclusion Criteria: * No consent * Known parental microdeletion 22q11.2 * Crown rump length \<45mm or \>84mm * Multiple pregnancies including vanishing twins

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As listed by the trial registrant

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

Pregnancy

Contacts and locations

Locations

  • University Hospital Tuebingen, Department of Women's Health

    Tübingen, 72076, Germany

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