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Clinical Trials in the USA / NCT07296419
Recruiting Not applicable

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

NCT07296419 · tracked via the Priya Life Science USA tracker
Sponsor
Raydiant Oximetry, Inc
Phase
Not applicable
Started
2025-12-08
Last updated
2025-12-22

Condition(s) studied

Fetal HypoxiaFetal Acidemia

Investigational drug(s) / intervention(s)

Fetal Pulse Oximetery

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Rate of device-related adverse events — Periprocedural
    Rate of device-related adverse events such as erythema or rash

Trial sites (1)

FacilityCityRegionStatus
LSU Health Science Center-Shreveport Shreveport Louisiana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07296419 on ClinicalTrials.gov ↗ ← All trials in the USA