Clinical trial NCT06405984: Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
Official title: Trans-Abdominal Fetal Pulse Oximetry - an Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Fetal Hypoxia
Fetal Distress
Fetal Conditions
Fetal Complications
Labor Fetal Anoxia
Labor (Obstetrics)--Complications
Oxygen Deficiency
Keywords: fetal hypoxia
fetal distress
oxygen deficiency
labor fetal anoxia
Lead sponsor: Raydiant Oximetry, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-05-09
Enrollment: 35
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 single-arm, device feasibility study, based on convenience sampling.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

Detailed description: This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.

Eligibility criteria: Inclusion Criteria:

1. Willing and capable to provide informed consent
2. Age \> 18 years
3. \< 4 cm between maternal skin and fetal skin (determined by ultrasound)
4. Gestational age \> 36 weeks
5. Singleton pregnancy
6. Vertex presentation
7. Active labor
8. Category I and Category II tracings, and
9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower

Exclusion Criteria:

1. Age \< 18 years
2. Gestational age \< 36 weeks
3. Multiple gestation
4. Nonvertex fetal presentation
5. Suspected vasa previa
6. Latent labor
7. Category III CTG tracing (i.e., need for immediate delivery)
8. Fetal anomalies and/or chromosomal disorders
9. Chorioamnionitis
10. Placenta Previa
11. History of HIV, Genital Herpes, or other infection precluding transvaginal monitoring
12. Unable to provide informed consent (e.g., cognitively impaired)
13. \> 4 cm fetal depth (determined by Ultrasound),
14. Low anterior placenta, or
15. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures

Primary outcomes:
measure: Feasibility of monitoring fetal signals.
timeFrame: During labor for up to 6 hours
measure: Safety of the prototype device
timeFrame: Up to 72 hours post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Sentara Norfolk General - Eastern Virginia Medical School
state: Virginia
Study officials:
References: