Device Modifications and Relocation of Principal Investigator

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.

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.

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)

Women who are in labor

This is for device development only, there is no plan to share IPD.

23 Females participated

Participants were monitored for adverse events during the day of participation. Participation was not to exceed 6 hours.

This study was deemed non-significant risk because Investigators were blinded to the fetal oxygen levels; therefore, no sensor data (internal or external) would be used to change clinical decision-making. There were no adverse events or serious adverse events in this study.

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

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.