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AI ultrasound aims to slash maternal deaths in ethiopia

NCT ID NCT07171086

Disease control Sponsor: Tsinghua University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether portable AI-driven ultrasound devices can help frontline health workers in rural Ethiopia detect pregnancy complications early. About 1,059 pregnant women will be split into three groups: two using different AI ultrasound tools and one receiving standard care without ultrasound. The goal is to see if AI-POCUS reduces maternal deaths, stillbirths, and preterm births.

What this could mean

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

Active substance
AI-POCUS ultrasound devices (BabyChecker and Edan)
What this could lead to
If successful, this could show that AI-assisted ultrasound by frontline health workers reduces maternal and newborn deaths in low-resource settings.
What could go wrong
This is a Phase 4 trial in a specific rural setting, so results may not apply elsewhere. The AI devices may not perform as well as expected, and training or technical issues could limit effectiveness.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,059 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 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

15 to 49 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. Aged 15-49 years; 2. Gestational age less than 24 weeks at the first ANC visit; 3. No history of severe pregnancy complications (e.g., placenta previa, preeclampsia, etc.); 4. Signed informed consent and agreed to participate in the study. Exclusion Criteria: 1. Pregnant women with cognitive impairments or unable to communicate effectively; 2. Failure to complete antenatal care within the specified timeframe; 3. Incomplete or unavailable records of antenatal care and delivery.

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Conditions

The condition(s) this trial relates to.

Fetal Death fetal growth restriction pregnancy disorder pregnancy disorder with abortive outcome Premature Birth Stillbirth

As listed by the trial registrant

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

Fetal growth restriction Pregnancy Pregnancy abnormal Pregnancy complications Preterm birth Stillbirth and fetal death

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

  • Hakim Gizaw Hospital

    Debre Berhan, Amhara, 1000, Ethiopia

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