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

University of California (UC) Davis

Status: Terminated

Conditions: Pregnancy, Abdominal

Treatments: Device: Raydiant Oximetry Sensor System

Study type: Interventional

Funder types: Other

Identifiers

NCT03013842

828902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than 36 weeks pregnant
• Singleton fetus

Exclusion criteria

• Prisoners

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Administration of Fetal Oximetry Probe

Experimental group

Description:

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

Treatment:

Device: Raydiant Oximetry Sensor System