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

NCT03013842 | Terminated

• 1 other identifier: 828902
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, Abdominal

Keywords

pregnancy; fetal monitoring; fetal oximetry; fetal heart rate; pulse oximetry; near 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 System DEVICE

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

Also known as: ROSS

Administration of Fetal Oximetry Probe

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Greater than 36 weeks pregnant
• Singleton fetus

You may not qualify if:

• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead
• CITRIS: collaborator

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Pregnancy, Abdominal

Condition Hierarchy (Ancestors)

Pregnancy, Ectopic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital 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)