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Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

RecruitingHealthy volunteers welcome

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

Full 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.

About the study

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.

What is being tested

Sponsor: Raydiant Oximetry, Inc. · Participants: 15 · Started: Dec 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07296419

Locations in the U.S.

LouisianaLSU Health Science Center-Shreveport, Shreveport

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.