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Can a simple blood draw map a Baby's genetic risks?

NCT ID NCT07106853

Diagnosis Sponsor: Women's Hospital School Of Medicine Zhejiang University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing two cell-free DNA blood tests to see how well they detect chromosomal and single-gene conditions in pregnancies with higher genetic risk, such as those with increased nuchal translucency or fetal structural anomalies. The study plans to enroll at least 1,600 pregnant adults, collect blood samples, and compare the blood test results with standard invasive or postnatal diagnostic testing. The goal is to measure accuracy and see whether the blood tests could guide clinical decisions.

What this could mean

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

Active substance
two cell-free DNA blood tests using targeted and whole-exome sequencing
What this could lead to
If the tests prove accurate, pregnant people at higher risk could one day get clearer genetic information from a simple blood draw, possibly reducing the need for invasive procedures like amniocentesis.
What could go wrong
This is a diagnostic accuracy study, not a treatment, and it may show the blood tests miss some conditions or raise false alarms. Results from a single study may not apply to all pregnancies, and abnormal findings would still need confirmation with invasive testing.

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 1,600 people

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

Started

Sep 2025

Expected to finish

Dec 2027

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

* Adult pregnant woman (≥18 years old) * Gestational age between 9+0 and 25+6 weeks * Singleton pregnancy * Pregnancy with indications for prenatal diagnosis due to: * Increased nuchal translucency (NT) ≥3.5 mm: capped at 25% of total subjects * Increased NT ≥3.5 mm AND presence of any other "soft marker" or structural anomaly: capped at 25% of total subjects * Presence of structural anomaly: at least 50% of total subjects * Agree to participate in the clinical study for being followed-up and accept at least one molecular diagnosis (diagnostic procedures performed on prenatal invasive specimens, product of conception, umbilical cord blood, or other specimens) and possible family member testing

Ages

18 years and older

Sex

Female participants only

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: * Adult pregnant woman (≥18 years old) * Gestational age between 9+0 and 25+6 weeks * Singleton pregnancy * Pregnancy with indications for prenatal diagnosis due to: * Increased nuchal translucency (NT) ≥3.5 mm: capped at 25% of total subjects * Increased NT ≥3.5 mm AND presence of any other "soft marker" or structural anomaly: capped at 25% of total subjects * Presence of structural anomaly: at least 50% of total subjects * Agree to participate in the clinical study for being followed-up and accept at least one molecular diagnosis (diagnostic procedures performed on prenatal invasive specimens, product of conception, umbilical cord blood, or other specimens) and possible family member testing Exclusion Criteria: * Age under 18 years * Gestational age is less than 9+0 weeks or greater than 25+6 weeks * One parent or other family member has a known pathogenic variant linked to the fetal ultrasound finding(s) * Conditions affecting the accuracy of cfDNA assay (e.g., maternal malignancy during pregnancy, maternal allogeneic blood transfusion, organ transplantation, or cell therapy within the past year)

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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 disease

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • The Chinese University of Hong Kong

    RECRUITING

    Hong Kong, Hong Kong

  • Women's Hospital School Of Medicine Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

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