Trans-abdominal Fetal Pulse Oximetry

NCT ID: NCT05147584

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-11-29

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.

Detailed Description

Raydiant Oximetry, Inc. is developing a novel and non-invasive fetal pulse oximetry device to fundamentally improve how fetuses are monitored during labor. The Raydiant Oximetry Sensing System (Lumerah) is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah performs its measurements without the requirement for transvaginal placement and its associated risks. Lumerah is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation which is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The severe consequences associated with newborn metabolic acidosis and the lack of availability of an effective tool to support its early diagnosis led to the development of Lumerah.

In this study, women in labor will be simultaneously monitored with proven (previously FDA-approved) technology as a "ground truth". These women will be simultaneously monitored with both an external and internal oxygen sensor. Obstetric health-care providers are blinded to oximetry data presented by both devices; therefore, clinical decisions regarding interventions are made based on the standard factors, including cardiotocography. The primary efficacy analysis will be performed retrospectively by comparing data of fetal oxygenation displayed and recorded by both devices. Results of either the Lumerah external sensor or the internal sensor will not be used to guide or alter patient management.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional/Observational

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.

Group Type: EXPERIMENTAL

Dual fetal oxygen sensors

Intervention Type: DEVICE

Placement of both internal and external fetal oxygen sensors

Interventions

Dual fetal oxygen sensors

Placement of both internal and external fetal oxygen sensors

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Willing and capable to provide informed consent

2. Age > 18 years

3. BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)

4. Gestational age > 36 weeks

5. Singleton pregnancy

6. Vertex presentation

7. Active labor

8. Category I or Category II tracings

9. Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower

Exclusion Criteria

1. Age <18 years

2. BMI > 50 third trimester

3. Gestational age < 36 weeks

4. Multiple gestation

5. Nonvertex fetal presentation

6. Suspected vasa previa

7. Latent labor

8. Category III CTG tracing (i.e., need for immediate delivery)

9. Fetal anomalies and/or chromosomal disorders

10. Chorioamnionitis

11. Placenta Previa

12. History of HIV, Genital Herpes, or other infection precluding internal monitoring

13. Unable to provide informed consent (e.g., cognitively impaired)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Raydiant Oximetry, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Rosen, MD

Role: STUDY_DIRECTOR

Raydiant Oximetry

Locations

University of Texas Medical Branch (UTMB)

Galveston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PILOT 1

Identifier Type: -

Identifier Source: org_study_id