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New belly sensor aims to monitor Baby's oxygen during birth

NCT ID NCT06405984

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, non-invasive device that uses light to measure a baby's oxygen levels through the mother's belly during labor. 35 women in labor participated. The device was used only for research and did not guide any medical decisions. The goal was to see if the device could safely detect signals from the baby.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

35 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 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. Willing and capable to provide informed consent 2. Age \> 18 years 3. \< 4 cm between maternal skin and fetal skin (determined by ultrasound) 4. Gestational age \> 36 weeks 5. Singleton pregnancy 6. Vertex presentation 7. Active labor 8. Category I and Category II tracings, and 9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower Exclusion Criteria: 1. Age \< 18 years 2. Gestational age \< 36 weeks 3. Multiple gestation 4. Nonvertex fetal presentation 5. Suspected vasa previa 6. Latent labor 7. Category III CTG tracing (i.e., need for immediate delivery) 8. Fetal anomalies and/or chromosomal disorders 9. Chorioamnionitis 10. Placenta Previa 11. History of HIV, Genital Herpes, or other infection precluding transvaginal monitoring 12. Unable to provide informed consent (e.g., cognitively impaired) 13. \> 4 cm fetal depth (determined by Ultrasound), 14. Low anterior placenta, or 15. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures

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Conditions

The condition(s) this trial relates to.

Fetal Distress Fetal Hypoxia Hypoxia obstetric disorder perinatal asphyxia pregnancy disorder

As listed by the trial registrant

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

Fetal complications Fetal conditions Fetal distress Fetal hypoxia Labor (obstetrics)--complications Labor fetal anoxia Oxygen deficiency

Contacts and locations

Locations

  • Sentara Norfolk General - Eastern Virginia Medical School

    Norfolk, Virginia, 23510, United States

More trials for these conditions

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