Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

Fetal Distress Clinical Trial

Official title:

Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04081623
• Other study ID #: ROSS Gen 2
• Status: Terminated
• Start date: April 16, 2019
• Est. completion date: June 8, 2021

Study information

• Verified date: August 2021
• Source: Raydiant Oximetry, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 8, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Distress

Intervention

Device:
• Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Raydiant Oximetry, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During NST, BPP, or active labor