Fetal Distress
Conditions
Brief 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.
Interventions
DEVICERaydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Sponsors
Raydiant Oximetry, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal signal integrity | During NST, BPP, or active labor | 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. |
Countries
United States
Outcome results
None listed