Trans-abdominal Fetal Pulse Oximetry

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05147584
Study type	Interventional
Source	Raydiant Oximetry, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	July 20, 2022
Completion date	November 29, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02221440` - Maternal Oxygen Administration for Fetal Distress	N/A
Completed	`NCT04325243` - Sildenafil Citrate and Intrapartum Fetal Distress	Phase 4
Completed	`NCT03095937` - Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients
Completed	`NCT00185887` - Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation	N/A
Completed	`NCT02862925` - Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.	N/A
Recruiting	`NCT06186973` - Fetal Assessment of the Myocardium and Evaluation of the Neonate
Recruiting	`NCT05681624` - Maternal Oxygen Supplementation for Intrauterine Resuscitation	N/A
Completed	`NCT05946681` - Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Completed	`NCT03536910` - Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique	N/A
Completed	`NCT03156608` - Novii External Fetal Monitoring Device	N/A
Recruiting	`NCT00246766` - Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy	N/A
Recruiting	`NCT04043299` - Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes	Phase 3
Not yet recruiting	`NCT03859037` - Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation	N/A
Completed	`NCT03370822` - A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
Not yet recruiting	`NCT05727241` - Three-dimensional Umbilical Cord Coiling Index
Terminated	`NCT04081584` - Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
Completed	`NCT03764696` - Maternal Oxygen Administration for Fetal Distress II	N/A
Completed	`NCT01042262` - Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase	N/A
Not yet recruiting	`NCT04548453` - Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions	Early Phase 1
Completed	`NCT03159234` - Prediction of Fetal Lung Maturity	N/A