NCT07296419 Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
| NCT ID | NCT07296419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Raydiant Oximetry, Inc. |
| Condition | Fetal Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-12-08 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Perry S Barrilleaux, MD
PRINCIPAL INVESTIGATOR
Louisiana State University Health Shreveport
Frequently Asked Questions
Who can join the NCT07296419 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fetal Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07296419 currently recruiting?
Yes, NCT07296419 is actively recruiting participants. Contact the research team at shannon.phillips@lsuhs.edu for enrollment information.
Where is the NCT07296419 trial being conducted?
This trial is being conducted at Shreveport, United States.
Who is sponsoring the NCT07296419 clinical trial?
NCT07296419 is sponsored by Raydiant Oximetry, Inc.. The principal investigator is Perry S Barrilleaux, MD at Louisiana State University Health Shreveport. The trial plans to enroll 15 participants.