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

Pregnancy, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03013842
• Other study ID #: 828902
• Status: Terminated
• Phase: N/A
• First received: December 5, 2016
• Last updated: January 29, 2018
• Start date: December 12, 2016
• Est. completion date: August 2, 2017

Study information

• Verified date: January 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Greater than 36 weeks pregnant

• Singleton fetus

Exclusion Criteria:

• Prisoners

Related Conditions & MeSH terms

• Pregnancy, Abdominal

Intervention

Device:
• Raydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	CITRIS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months