Trans-abdominal Fetal Pulse Oximetry

Not Applicable

Terminated

Conditions: Fetal Acidemia
Fetal Hypoxia
Fetal Distress
Fetal or Neonatal Effect of Complication of Labor

Interventions: Device: Dual fetal oxygen sensors

Registration Number: NCT05147584

Lead Sponsor: Raydiant Oximetry, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 31

Inclusion Criteria

Willing and capable to provide informed consent
Age > 18 years
BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)
Gestational age > 36 weeks
Singleton pregnancy
Vertex presentation
Active labor
Category I or Category II tracings
Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower

Exclusion Criteria

Age <18 years
BMI > 50 third trimester
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 internal monitoring
Unable to provide informed consent (e.g., cognitively impaired)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional/Observational	Dual fetal oxygen sensors	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.

Primary Outcome Measures

Name	Time	Method
Fetal Oxygen Levels	During labor	Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.
Adverse Events	During labor	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.

Secondary Outcome Measures