Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

NCT06405984 | Completed Early Phase 1 DMC FDA Device

• 2 other identifiers: CP2340R44HD094486
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

Conditions

Fetal Hypoxia; Fetal Distress; Fetal Conditions; Fetal Complications; Labor Fetal Anoxia; Labor (Obstetrics)--Complications; Oxygen Deficiency

Keywords

fetal hypoxia; fetal distress; oxygen deficiency; labor fetal anoxia

Outcome Measures

Primary Outcomes (2)

• Feasibility of monitoring fetal signals.

  Prototype device feasibility of detecting reflected optical signals at different wavelengths ("colors") from the fetus

  During labor for up to 6 hours

• Safety of the prototype device

  Rate of adverse events and serious adverse events

  Up to 72 hours post partum

Study Arms (1)

Laboring Women

EXPERIMENTAL

Women in labor who have consented to participation in the study.

Device: Fetal Oxygenation Measurements

Interventions

Fetal Oxygenation Measurements DEVICE

The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.

Laboring Women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study applies to women 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
• \< 4 cm between maternal skin and fetal skin (determined by ultrasound)
• Gestational age \> 36 weeks
• Singleton pregnancy
• Vertex presentation
• Active labor
• Category I and Category II tracings, and
• Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower

You may not qualify if:

• Age \< 18 years
• 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 transvaginal monitoring
• Unable to provide informed consent (e.g., cognitively impaired)
• \> 4 cm fetal depth (determined by Ultrasound),
• Low anterior placenta, or
• Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Sentara Norfolk General - Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Fetal Hypoxia; Fetal Distress; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Although it is known what devices are used, all personnel on the investigative team will be masked to fetal oxygenation levels during data collection.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, device feasibility study, based on convenience sampling.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 9, 2024
• Study Start: April 15, 2024
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)