Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

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,

Study Overview

• Status: Terminated
• Conditions: Fetal Distress
• Intervention / Treatment: Device: Raydiant Oximetry Sensing System

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinic; This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)	Device: Raydiant Oximetry Sensing System; The investigational device is used to record fetal pulse signals.; Other Names: ROSS
Labor and Delivery; This group is in active labor.	Device: Raydiant Oximetry Sensing System; The investigational device is used to record fetal pulse signals.; Other Names: ROSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Raydiant Oximetry, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: ROSS Gen 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No