Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

Raydiant Oximetry, Inc.9 enrolled

Overview

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,

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

Conditions

Fetal Distress

Interventions

Raydiant Oximetry Sensing SystemDEVICE

The investigational device is used to record fetal pulse signals.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: During NST, BPP, or active labor

Data from ClinicalTrials.gov

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