Recruiting

Fetal SpO2

Sponsor:

Raydiant Oximetry, Inc.

Code:

NCT07296419

Conditions

Fetal Hypoxia

Fetal Acidemia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Fetal Pulse Oximetery

Study Details

Brief summary:

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.

Conditions

Fetal Hypoxia

Fetal Acidemia

Study ID

NCT07296419

Start date

Dec 8, 2025

Status verified date

Dec, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Dual Sensor Recipients

Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.

Interventions

Fetal Pulse Oximetery

Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

Primary outcome measure

  • Rate of device-related adverse events [ Time Frame: Periprocedural ]

Central Contacts and Locations

Central contacts

Shannon Phillips, RN, BSN

318-675-7207shannon.phillips@lsuhs.edu

Chelsie Liegey, LPC, RN

318-675-7064

Locations

LSU Health Science Center-Shreveport

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Shannon Phillips, RN

318-675-7207shannon.phillips@lsuhs.edu

Chelsie Liegey, RN

chelsie.liegey@lsuhs.edu

Principal Investigator:

Perry S Barrilleaux, MD

More Information

Sponsor

Raydiant Oximetry, Inc.

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Raydiant Oximetry, Inc. on 2025-12-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.