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Can a detailed fetal gene test guide pregnancy care without adding stress?

NCT ID NCT05290701

Knowledge-focused Sponsor: Leiden University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

Researchers are studying how prenatal exome sequencing, a detailed genetic test of fetal DNA, influences medical decisions and parental wellbeing in pregnancies where an anomaly has been detected. The study will compare different ways of analyzing the test results, including definitive diagnoses, probable diagnoses, and incidental findings. Parents will answer questionnaires about anxiety, decision-making, and regret. The goal is to understand the benefits and harms of this testing approach.

What this could mean

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

Active substance
Prenatal exome sequencing (pES), a genetic test on fetal DNA
What this could lead to
If it works, this could clarify how best to use prenatal exome sequencing to guide pregnancy care and support parents facing fetal anomalies.
What could go wrong
This is an observational study, so it won't prove that sequencing improves outcomes. It may also find that certain results increase parental anxiety or lead to difficult decisions.

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

235 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2026

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 with one or more ultrasound findings during the current pregnancy who consent to pES, and their partner.

Ages

18 years and older

Sex

Anyone

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: * At least one fetal anomaly detected in the current pregnancy, irrespective of gestational age; * Pregnancy ongoing; * Mother at least 18 years old and providing consent for pES; * If father is available: father at least 18 years old and providing consent for pES. Exclusion Criteria: There are no exclusion criteria.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities hereditary disease

As listed by the trial registrant

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

Congenital anomalies Genetic diseases, inborn Mendelian disorders

Contacts and locations

Locations

  • Leiden University Medical Centre

    Leiden, South Holland, 2333ZA, Netherlands

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