Clinical trial NCT05147584: Trans-abdominal Fetal Pulse Oximetry
Official title: Trans-abdominal Fetal Pulse Oximetry: PILOT 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Hypoxia
Fetal Distress
Fetal Acidemia
Fetal or Neonatal Effect of Complication of Labor
Lead sponsor: Raydiant Oximetry, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fetal Oxygen Levels
timeFrame: During labor
measure: Adverse Events
timeFrame: During labor
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB)
state: Texas
Study officials:
affiliation: Raydiant Oximetry
name: Mark Rosen, MD
role: STUDY_DIRECTOR
References: