Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

Raydiant Oximetry

Status: Terminated

Conditions: Fetal Distress

Treatments: Device: Raydiant Oximetry Sensing System

Study type: Observational

Funder types: Industry

Identifiers

NCT04081623

ROSS Gen 2

Details and patient eligibility

About

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,

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pregnant women with singleton pregnancies, vertex presentation
2. Age ≥ 18 years
3. Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
4. Healthy women ≥ 37 weeks in labor
5. Vertex presentation

Exclusion criteria

1. Age <18 years
2. Multiple gestation ( twins, triplets)
3. Presentation other than vertex
4. < 28 weeks of gestation

Trial design

9 participants in 2 patient groups

Clinic

Description:

This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)

Treatment:

Device: Raydiant Oximetry Sensing System

Labor and Delivery

Description:

This group is in active labor.

Treatment:

Device: Raydiant Oximetry Sensing System