NCT03013842

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

December 12, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

December 5, 2016

Last Update Submit

January 29, 2018

Conditions

Pregnancy, Abdominal

Keywords

pregnancyfetal monitoringfetal oximetryfetal heart ratepulse oximetrynear infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Fetal Heart Rate

    6 months

Study Arms (1)

Administration of Fetal Oximetry Probe

EXPERIMENTAL

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

Device: Raydiant Oximetry Sensor System

Interventions

Raydiant Oximetry Sensor SystemDEVICE

Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women

Also known as: ROSS
Administration of Fetal Oximetry Probe

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Greater than 36 weeks pregnant
  • Singleton fetus

You may not qualify if:

  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Pregnancy, Abdominal

Condition Hierarchy (Ancestors)

Pregnancy, EctopicPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Neil Ray, MD

    916-734-5028

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2016

First Posted

January 9, 2017

Study Start

December 12, 2016

Primary Completion

August 2, 2017

Study Completion

August 2, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)