Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

Terminated

• Conditions: Fetal Distress
• Interventions: Device: Raydiant Oximetry Sensing System

• Registration Number: NCT04081623
• Lead Sponsor: Raydiant Oximetry, Inc.

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.

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinic	Raydiant Oximetry Sensing System	This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)
Labor and Delivery	Raydiant Oximetry Sensing System	This group is in active labor.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States