RecruitingNot ApplicableNCT07296419

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

Sponsor

Raydiant Oximetry, Inc.

Enrollment

15 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Fetal Hypoxia Fetal Acidemia

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: FEMALEMin Age: 18 Years

Inclusion Criteria9

Willing and capable of providing informed consent.
Age \> 18 years.
Gestational age \> 36 weeks.
Singleton pregnancy.
Vertex presentation,
In latent or active labor,
Category I or II tracings,
Epidural anesthesia, and
Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower.

Exclusion Criteria13

Age \< 18 years.
Gestational age \< 36 weeks
Multiple gestation
Nonvertex fetal presentation
Suspected vasa previa
Category III CTG tracing
Fetal anomalies and/or chromosomal disorders
Chorioamnionitis
Placenta previa
HIV, genital Herpes, or other infection precluding transvaginal monitoring
Unable to provide informed consent (e.g., cognitively impaired)
Low anterior placenta, or
Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.