Trans-abdominal Fetal Pulse Oximetry

NCT05147584 | Terminated Results DMC FDA Device

• 1 other identifier: PILOT 1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Conditions

Fetal Hypoxia; Fetal Distress; Fetal Acidemia; Fetal or Neonatal Effect of Complication of Labor

Outcome Measures

Primary Outcomes (2)

• Fetal Oxygen Levels

  Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.

  During labor

• Adverse Events

  Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum. Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.

  During labor

Study Arms (1)

Interventional/Observational

EXPERIMENTAL

The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively.

Device: Dual fetal oxygen sensors

Interventions

Dual fetal oxygen sensors DEVICE

Placement of both internal and external fetal oxygen sensors

Interventional/Observational

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who are in labor
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable to provide informed consent
• Age \> 18 years
• BMI \< 50 (with no more than 4 cm between maternal skin and fetal skin)
• Gestational age \> 36 weeks
• Singleton pregnancy
• Vertex presentation
• Active labor
• Category I or Category II tracings
• Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower

You may not qualify if:

• Age \<18 years
• BMI \> 50 third trimester
• Gestational age \< 36 weeks
• Multiple gestation
• Nonvertex fetal presentation
• Suspected vasa previa
• Latent labor
• Category III CTG tracing (i.e., need for immediate delivery)
• Fetal anomalies and/or chromosomal disorders
• Chorioamnionitis
• Placenta Previa
• History of HIV, Genital Herpes, or other infection precluding internal monitoring
• Unable to provide informed consent (e.g., cognitively impaired)

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Fetal Hypoxia; Fetal Distress

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a research and development study designed to determine if the Lumerah system needed additional modifications to enhance the fetal signal.

Results Point of Contact

• Title: Laura Kemp
• Organization: Raydiant Oximetry, Inc.

laurakemp@raydiantoximetry.com

4083751465

Study Officials

• Mark Rosen, MD

  Raydiant Oximetry

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Results of either the external sensor or the internal sensor will not be shown to the subject, the care provider, or the investigator and will not be used to guide or alter patient management. The "outcomes assessor" will review the subject CTG and sensor data retrospectively.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, investigator-blinded study that is for data collection only. The primary purpose is to verify accuracy during the training of the algorithm by comparing the external sensor to a known internal sensor.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: July 20, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)