RecruitingNot Applicable

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

United States15 participantsStarted 2025-12-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Rate of device-related adverse events

Timeframe: Periprocedural

Trial details

NCT IDNCT07296419

SponsorRaydiant Oximetry, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Shannon Phillips, RN, BSN

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

View on ClinicalTrials.gov More Fetal Hypoxia trials