TerminatedNot Applicable

Trans-abdominal Fetal Pulse Oximetry

Stopped: Device Modifications and Relocation of Principal Investigator

United States31 participantsStarted 2022-07-20

Plain-language summary

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Willing and capable to provide informed consent
✓. Age \> 18 years
✓. BMI \< 50 (with no more than 4 cm between maternal skin and fetal skin)
✓. Gestational age \> 36 weeks
✓. Singleton pregnancy
✓. Vertex presentation
✓. Active labor
✓. Category I or Category II tracings

Exclusion criteria

✕. Age \<18 years
✕. BMI \> 50 third trimester
✕. Gestational age \< 36 weeks
✕. Multiple gestation
✕. Nonvertex fetal presentation
✕. Suspected vasa previa
✕. Latent labor
✕. Category III CTG tracing (i.e., need for immediate delivery)

What they're measuring

Fetal Oxygen Levels

Timeframe: During labor

Adverse Events

Timeframe: During labor

Trial details

NCT IDNCT05147584

SponsorRaydiant Oximetry, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-29

Results submitted2024-12-18

View on ClinicalTrials.gov More Fetal Hypoxia trials