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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
31
Placement of both internal and external fetal oxygen sensors
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States
Fetal Oxygen Levels
Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.
Time frame: 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.
Time frame: During labor
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