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New study aims to predict heart risks in pregnancy with simple monitoring

NCT ID NCT07526662

Knowledge-focused Sponsor: Yihua He,MD 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study will enroll 1,000 pregnant women and their fetuses to establish normal ranges for heart sounds and ECGs. The goal is to develop early warning systems for serious heart events in mothers, progression of fetal heart defects, and autoimmune-related fetal heart block. Participants will undergo non-invasive monitoring, and researchers will track outcomes to build a risk stratification system.

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, this could lead to better early detection and risk assessment for heart complications during pregnancy, potentially improving outcomes for mothers and babies.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any intervention, and the models developed may need further validation before clinical use.

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.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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

This study population consists of pregnant women aged 18-45 years with singleton pregnancies, including those with pregnancy-associated heart disease, anti-Ro/SSA antibody positivity, and healthy controls, and their fetuses, enrolled at Beijing Anzhen Hospital.

Ages

18 to 45 years

Sex

Female participants only

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: 1. Pregnant women aged 18 to 45 years with singleton pregnancy; 2. For maternal groups: diagnosed with heart disease (congenital, valvular, or cardiomyopathy) or healthy without cardiac disease; 3. For fetal groups: diagnosed with congenital heart disease, anti-Ro/SSA antibody positive status, or normal cardiac structure; 4. Able to cooperate with non-invasive monitoring and follow-up procedures; 5. Voluntary written informed consent provided prior to enrollment. Exclusion Criteria: 1. Multiple pregnancy; 2. Severe skin disease or thoracic deformity preventing placement of monitoring sensors; 3. History of malignancy, severe hepatic or renal dysfunction; 4. Inability to complete follow-up visits or monitoring; 5. Contraindications to non-invasive monitoring procedures.

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Conditions

The condition(s) this trial relates to.

congenital heart block congenital heart disease neonatal lupus erythematosus peripartum cardiomyopathy

As listed by the trial registrant

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

Autoimmune-related fetal heart block Fetal congenital heart disease Perinatal adverse events Pregnancy-associated heart disease

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

  • Beijing An Hospital, Capital Medical University

    Beijing, 100011, China