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AI ultrasound could bring lifesaving pregnancy checks to remote villages

NCT ID NCT07677670

Diagnosis Sponsor: SOIK Corporation Sarl 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests whether a smartphone-based AI ultrasound, operated by health workers with minimal training, can accurately estimate gestational age, detect placenta position, and identify fetal presentation in pregnant women in rural Democratic Republic of the Congo. The goal is to see if this technology can replace the need for specialist sonographers in remote areas. Around 1,430 to 3,000 pregnant women will participate, and the AI's results will be compared to standard measurements by expert readers.

What this could mean

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

Active substance
SPAQ E-con AI blind-sweep ultrasound
What this could lead to
If accurate, this could bring essential antenatal screening to remote areas lacking specialist sonographers, improving maternal and fetal health.
What could go wrong
The AI may not perform as well in real-world rural settings, and the study is limited to one region in DRC, so results may not apply elsewhere.

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 3,000 people

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

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 attending routine antenatal care at participating facilities or identified through community health worker (RECO) village outreach in the Kenge health zone, Kwango province, DRC.

Ages

18 years and older

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: * Pregnant women aged 18 years or older * Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment * Written informed consent obtained Exclusion Criteria: * Emergency presentation * Duplicate re-registration of an already-enrolled woman * Lacking capacity to consent * Planned relocation outside Kwango province during the study period * Refusal of consent

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Conditions

The condition(s) this trial relates to.

placenta praevia

As listed by the trial registrant

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

Antenatal care Diagnostic imaging Gestational age Maternal health Placenta praevia

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

  • Centre de Sante CBCO

    RECRUITING

    Kenge, Kwango, Democratic Republic of the Congo

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