Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

NCT ID: NCT06405984

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-10-17

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.

Detailed Description

This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.

Conditions

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

Study Design

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

Study Groups

Laboring Women

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

Group Type: EXPERIMENTAL

Fetal Oxygenation Measurements

Intervention Type: 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.

Interventions

Fetal Oxygenation Measurements

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Raydiant Oximetry, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sentara Norfolk General - Eastern Virginia Medical School

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

R44HD094486

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CP2340

Identifier Type: -

Identifier Source: org_study_id