NCT04081623

Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Raydiant Oximetry, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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,

Detailed description

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.

Conditions

• Fetal Distress

Interventions

Type	Name	Description
DEVICE	Raydiant Oximetry Sensing System	The investigational device is used to record fetal pulse signals.

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-05-20
• Completion: 2021-06-08
• First posted: 2019-09-09
• Last updated: 2021-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study