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Prenatal genome sequencing: helpful or just worrying?

NCT ID NCT07610590

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study looks at whether genome sequencing (reading nearly all of a baby's genes) should be used more routinely during pregnancy, even when ultrasounds look normal. Researchers will compare this test with current standard prenatal testing in over 1,000 families to see if it finds more genetic conditions and how parents use that information. The goal is to understand if genome sequencing can be offered in a way that is helpful, responsible, and supportive for families.

What this could mean

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

Active substance
Genome sequencing (GS)
What this could lead to
If successful, this could show that genome sequencing is a helpful and responsible addition to routine prenatal care, giving families more information about their baby's health.
What could go wrong
This is an observational study, not a treatment trial. It may find genetic variants of uncertain significance, which can cause anxiety without clear answers. Results may not apply to all populations.

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

About 1,042 people

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

Started

Apr 2026

Expected to finish

Jul 2029

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.

Ages

18 years and older

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: * Patient planned chorionic villus sampling (CVS) or amniocentesis in the absence of major fetal structural anomalies (minor anomalies are eligible, the HPO (Human Phenotype Ontology) will not be used by the analyst) * Certified genetic counselor involved in care Exclusion Criteria: * A major structural anomaly * Maternal or paternal age less than 18 years old * Parental unwillingness to participate in 1 year of postnatal follow-up * Language barrier (non-English or Spanish speaking)

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As listed by the trial registrant

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

Prenatal genetic diagnosis

How to take part

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

  1. The places running it

    1 site. 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

  • Boston Childrens Hospital

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Columbia University Irving Medical Center (CUIMC)

    RECRUITING

    New York, New York, 10032, United States

  • New York Genome Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10013, United States

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