Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013842
Recruitment Status : Terminated (Principal Investigator no longer at Site)
First Posted : January 9, 2017
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
CITRIS
Information provided by (Responsible Party):
University of California, Davis

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.


Condition or disease Intervention/treatment Phase
Pregnancy, Abdominal Device: Raydiant Oximetry Sensor System Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Arm Intervention/treatment
Experimental: Administration of Fetal Oximetry Probe
Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
Device: Raydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Other Name: ROSS




Primary Outcome Measures :
  1. Fetal Photoplethysmogram [ Time Frame: 6 months ]
    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 :
  1. Fetal Heart Rate [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 36 weeks pregnant
  • Singleton fetus

Exclusion Criteria:

  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013842


Locations
Layout table for location information
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
CITRIS
Investigators
Layout table for investigator information
Principal Investigator: Neil Ray, MD 916-734-5028

Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03013842    
Other Study ID Numbers: 828902
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
pregnancy
fetal monitoring
fetal oximetry
fetal heart rate
pulse oximetry
near infrared spectroscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy, Abdominal
Pregnancy, Ectopic
Pregnancy Complications