Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is a prospective, investigator-blinded study that is for data collection only. The primary purpose is to verify accuracy during the training of the algorithm by comparing the external sensor to a known internal sensor.
Primary Purpose
Other
Masking
None (Open Label)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Interventional/Observational
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.
  • Device: Dual fetal oxygen sensors
    Placement of both internal and external fetal oxygen sensors

Recruiting Locations

University of Texas Medical Branch (UTMB)
Galveston, Texas 77555
Contact:
Ashley Salazar, MSN, RN
assalaza@utmb.edu

More Details

Status
Recruiting
Sponsor
Raydiant Oximetry, Inc.

Study Contact

Pamela Zicker, NP
831-239-4115
pamela.zicker@raydiantoximetry.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.