An interventional study of Fetal Pulse Oximetery in Fetal Hypoxia and Fetal Acidemia, sponsored by Raydiant Oximetry, Inc.. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Raydiant Oximetry, Inc. · Not applicable, Interventional, and Other
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.
The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH\<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.
In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.
23 studies on the registry are indexed under Fetal Hypoxia; 6 are open to participants now.
This study's planned enrollment of 15 is below the median of 145 across 18 interventional studies indexed under Fetal Hypoxia.
Browse Fetal Hypoxia studies →Raydiant Oximetry, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.
Device: Fetal Pulse Oximetery
Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.
Rate of device-related adverse events
Rate of device-related adverse events such as erythema or rash
Time frame: Periprocedural
Maternal Outcomes
Maternal adverse outcomes such as chorioamnionitis or endometritis
Time frame: Periprocedural
Neonatal Outcomes
Apgar Scores at 1 and 5 minutes
Time frame: Periprocedural
Plan to share: No — Individual participant data is available to Raydiant Oximetry and LSU Study Staff only.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Mar 2026, 3 months after the start.
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Raydiant Oximetry, Inc.