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Could a simple heart scan save mothers and babies?

NCT ID NCT04936815

Diagnosis Sponsor: Thomas Pilgrim 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving pregnant women a heart ultrasound during routine check-ups can catch hidden heart problems and reduce risks like death, heart failure, or low baby health scores. About 9,000 women in Nepal will be randomly assigned to receive the ultrasound or standard care. Researchers will track outcomes for mothers and babies up to six weeks after birth.

What this could mean

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

Active substance
transthoracic echocardiography (heart ultrasound)
What this could lead to
If it works, this could show that routine heart screening during pregnancy helps prevent serious complications like heart failure or death in mothers and newborns.
What could go wrong
This is a single-site trial in Nepal, so results may not apply everywhere. The screening might not reduce complications enough to be worth the cost or effort.

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 9,000 people

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

Started

Dec 2021

Expected to finish

Mar 2026

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

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: * Pregnant women ≥18 years presenting for routine antenatal care. * Written informed consent. Exclusion Criteria: * Women presenting to the hospital after delivery. * Women presenting directly for delivery without previous antenatal care.

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Conditions

The condition(s) this trial relates to.

heart valve disorder pregnancy disorder rheumatic heart disease

As listed by the trial registrant

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

Pregnancy complications Rheumatic heart disease Valvular heart disease

Contacts and locations

Locations

  • B.P. Koirala Institute of Health Sciences

    Dharān, 56700, Nepal

  • Department of Cardiology, Bern University Hospital

    Bern, 3010, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.