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New genetic test may unlock mysteries of unborn Babies' health

NCT ID NCT07606989

Diagnosis Sponsor: Women's Hospital School Of Medicine Zhejiang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a detailed genetic test called whole-genome sequencing (WGS) can find the cause of physical problems in unborn babies when standard tests have not. Researchers will study 1,000 pregnant women whose fetuses have structural issues seen on ultrasound or MRI but no clear genetic answer. The goal is to help families understand the cause and make better decisions about the pregnancy.

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 1,000 people

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

Started

Mar 2026

Expected to finish

Mar 2028

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

Pregnant women aged 18 years or older with singleton pregnancies, whose fetuses have structural abnormalities detected by ultrasound or MRI between 11+0 and 32+0 weeks of gestation, and who are scheduled to undergo invasive or postnatal genetic diagnostic procedures.

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: 1. Pregnant women aged ≥ 18 years. 2. Singleton pregnancy. 3. Gestational age between 11+0 and 32+0 weeks, with ultrasound or MRI indicating a definite structural malformation in the fetus (may be with or without soft marker abnormalities) requiring prenatal diagnosis (see Appendices 1 and 2). Fetal developmental abnormalities include those of the central nervous system, cardiovascular system, craniofacial/neck region, chest/mediastinum, abdomen/digestive tract, urinary system, skeletal system/limbs, and systemic abnormalities such as fetal hydrops, abnormally thickened placenta with hydrops, and severe growth restriction. Criteria for ultrasound soft markers and structural malformations are provided in the appendices. 4. Planned to undergo at least one invasive or postnatal procedure for genetic diagnosis, and consent to the use of residual diagnostic samples for research testing. 5. Signed unified informed consent form, agreement to follow-up, and consent for storage and submission of samples and data according to the protocol. Exclusion Criteria: 1. Age \< 18 years or individuals lacking full capacity for civil conduct. 2. Twin or multiple pregnancies. 3. Known parental or familial carrier status of a pathogenic variant highly consistent with the current fetal phenotype, where testing is planned only for targeted confirmation. 4. Refusal to consent to the storage and use of samples and data for this study. 5. Other conditions deemed unsuitable for participation in this study by the investigator.

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Conditions

The condition(s) this trial relates to.

Fetal Diseases

As listed by the trial registrant

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

Fetal diseases Prenatal diagnosis

How to take part

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

  1. The places running it

    4 sites. 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

  • Huzhou Maternity & Child Care Hospital

    RECRUITING

    Huzhou, Zhejiang, 313000, China

  • Quzhou Maternal and Child Health Care Hospital

    RECRUITING

    Quzhou, Zhejiang, 324000, China

  • Shaoxing Maternity & Child Care Hospital

    RECRUITING

    Shaoxing, Zhejiang, 312000, China

  • Women's Hospital School of Medicine Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

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