Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.

Study Overview

• Status: Recruiting
• Conditions: Fetal Hypoxia; Fetal Acidemia
• Intervention / Treatment: Device: Fetal Pulse Oximetery

Detailed Description

The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.

In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Phillips, RN, BSN; Phone Number: 318-675-7207; Email: shannon.phillips@lsuhs.edu
• Study Contact Backup: Name: Chelsie Liegey, LPC, RN; Phone Number: 318-675-7064

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • LSU Health Science Center-Shreveport
      • Contact: Shannon Phillips, RN; Phone Number: 318-675-7207; Email: shannon.phillips@lsuhs.edu
      • Contact: Chelsie Liegey, RN; Email: chelsie.liegey@lsuhs.edu
      • Principal Investigator: Perry S Barrilleaux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Willing and capable of providing informed consent.
2. Age > 18 years.
3. Gestational age > 36 weeks.
4. Singleton pregnancy.
5. Vertex presentation,
6. In latent or active labor,
7. Category I or II tracings,
8. Epidural anesthesia, 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. Category III CTG tracing
7. Fetal anomalies and/or chromosomal disorders
8. Chorioamnionitis
9. Placenta previa
10. HIV, genital Herpes, or other infection precluding transvaginal monitoring
11. Unable to provide informed consent (e.g., cognitively impaired)
12. Low anterior placenta, or
13. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Sensor Recipients; Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.	Device: Fetal Pulse Oximetery; Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device-related adverse events	Rate of device-related adverse events such as erythema or rash	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Outcomes	Maternal adverse outcomes such as chorioamnionitis or endometritis	Periprocedural
Neonatal Outcomes	Apgar Scores at 1 and 5 minutes	Periprocedural

Collaborators and Investigators

• Sponsor: Raydiant Oximetry, Inc.
• Investigators: Principal Investigator: Perry S Barrilleaux, MD, Louisiana State University Health Shreveport

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Signs and Symptoms, Respiratory; Hypoxia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fetal Hypoxia
• Other Study ID Numbers: CP2555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is available to Raydiant Oximetry and LSU Study Staff only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes