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Safer down syndrome test could replace Needle-Based procedure

NCT ID NCT02127515

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compared a simple blood test (noninvasive prenatal testing, or NIPT) with the standard invasive procedure (amniocentesis or chorionic villus sampling) for detecting Down syndrome in over 2,100 pregnant women at high risk. The goal was to see if NIPT could reduce miscarriages while still accurately identifying cases. Women were randomly assigned to either the blood test or the invasive test, and researchers tracked miscarriage rates, accuracy, and costs.

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, NIPT could become a safer, noninvasive option for prenatal Down syndrome screening, reducing the need for invasive tests and their associated miscarriage risk.
What could go wrong
This trial is completed but results are not yet widely implemented. NIPT may have false positives or negatives, and it is not a diagnostic test—only a screening tool.

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

2,111 people

The number who actually took part.

Started

Apr 2014

Finished

Nov 2016

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

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 women over 18 * at risk for Down syndrome\> 1/250 based on combined screening using ultrasound together with maternal serum markers and prior to fetal karyotyping * singleton pregnancy * pregnancy between 11SA et 18SA * willing a fetal karyotype Exclusion Criteria: * risk for Down syndrome\< 1/250 or \>1/5 * NT\> 3 mm, PAPP-A or beta HCG \<0.3 MoM or \>5 MoM * multiple pregnancy , vanishing twin * morphological abnormalities at US * Kown chromosomal anomaly in parents * Patients not willing a fetal karyotype

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Conditions

The condition(s) this trial relates to.

Abortion, Spontaneous Down syndrome

As listed by the trial registrant

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

Down syndrome

Contacts and locations

Locations

  • Hôpital Necker- Enfants Malades

    Paris, 75015, France

More trials for these conditions

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