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Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects

Primary Purpose

Pregnancy, Abdominal

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raydiant Oximetry Sensor System
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pregnancy, Abdominal focused on measuring pregnancy, fetal monitoring, fetal oximetry, fetal heart rate, pulse oximetry, near infrared spectroscopy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Greater than 36 weeks pregnant
  • Singleton fetus

Exclusion Criteria:

  • Prisoners

Sites / Locations

  • University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of Fetal Oximetry Probe

Arm Description

Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women

Outcomes

Primary Outcome Measures

Fetal Photoplethysmogram
The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.

Secondary Outcome Measures

Fetal Heart Rate
The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.

Full Information

First Posted
December 5, 2016
Last Updated
January 29, 2018
Sponsor
University of California, Davis
Collaborators
CITRIS
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1. Study Identification

Unique Protocol Identification Number
NCT03013842
Brief Title
Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Official Title
Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator no longer at Site
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
August 2, 2017 (Actual)
Study Completion Date
August 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
CITRIS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate. We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen. Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.
Detailed Description
The study subject will have a brief trans-abdominal ultrasound examination. 3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina. It is anticipated that 6 months will be required to recruit, consent and study 25 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Abdominal
Keywords
pregnancy, fetal monitoring, fetal oximetry, fetal heart rate, pulse oximetry, near infrared spectroscopy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of Fetal Oximetry Probe
Arm Type
Experimental
Arm Description
Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
Intervention Type
Device
Intervention Name(s)
Raydiant Oximetry Sensor System
Other Intervention Name(s)
ROSS
Intervention Description
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Primary Outcome Measure Information:
Title
Fetal Photoplethysmogram
Description
The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fetal Heart Rate
Description
The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Greater than 36 weeks pregnant Singleton fetus Exclusion Criteria: Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Ray, MD
Organizational Affiliation
916-734-5028
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects

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