An observational study in Fetal Distress, sponsored by Raydiant Oximetry, Inc.. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Raydiant Oximetry, Inc. · Observational
This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.
35 studies on the registry are indexed under Fetal Distress; 7 are open to participants now.
This study's enrollment of 9 is below the median of 90 across 11 observational studies indexed under Fetal Distress.
Browse Fetal Distress studies →Raydiant Oximetry, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor
Exclusion Criteria:
This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)
Device: Raydiant Oximetry Sensing System
This group is in active labor.
Device: Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Also known as: ROSS
Fetal signal integrity
Integrity of the fetal signal relative to background maternal signal and biologic/electronic noise, and related to fetal position, presentation and the depth of the fetus from maternal skin.
Time frame: During NST, BPP, or active labor
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Raydiant Oximetry, Inc.