Trans-abdominal Fetal Pulse Oximetry: Signal Integrity

NCT ID: NCT04081623

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-16

Study Completion Date

2021-06-08

Brief Summary

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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

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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.

Conditions

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Fetal Distress

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic

This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)

Raydiant Oximetry Sensing System

Intervention Type DEVICE

The investigational device is used to record fetal pulse signals.

Labor and Delivery

This group is in active labor.

Raydiant Oximetry Sensing System

Intervention Type DEVICE

The investigational device is used to record fetal pulse signals.

Interventions

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Raydiant Oximetry Sensing System

The investigational device is used to record fetal pulse signals.

Intervention Type DEVICE

Other Intervention Names

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ROSS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Raydiant Oximetry, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ROSS Gen 2

Identifier Type: -

Identifier Source: org_study_id

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