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New belly sensor could spot baby distress before birth

NCT ID NCT04876846

Knowledge-focused Sponsor: Raydiant Oximetry, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new device that shines light through a pregnant woman's belly to measure oxygen levels in her unborn baby. Nine healthy women in late pregnancy took part. The goal was to see if the device could pick up a clear signal from the baby, which could lead to a safer way to monitor fetal health.

What this could mean

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

Active substance
Trans-abdominal fetal pulse oximetry device
What this could lead to
If successful, this could lead to a non-invasive way to monitor oxygen levels in unborn babies, helping detect distress early.
What could go wrong
This is a very small, early study with only 9 participants. It is focused on measuring light scattering, not yet on clinical outcomes. The device may not work as expected in real-world settings.

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

9 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2025

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.

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: 1. Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks 2. Age \> 18 years 3. Willing to come in for testing outside of routine business hours (including Saturdays) Exclusion Criteria: 1. Age \<18 2. Multiple gestation (twins, triplets) 3. Presentation other than vertex or breech 4. \< 36 weeks of gestation

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Conditions

The condition(s) this trial relates to.

Fetal Hypoxia

As listed by the trial registrant

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

Fetal hypoxia

Contacts and locations

Locations

  • Yaron Friedman, MD, Inc.

    Walnut Creek, California, 94598, United States

More trials for these conditions

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