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NCT04081584 Clinical Trial

Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Fetal Distress Clinical Trial

Official title:
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04081584
Other study ID # ISS
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date June 8, 2021

Study information
Verified date August 2021
Source Raydiant Oximetry, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is being conducted to study light scattering properties of maternal-fetal tissue.

Description:

The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date June 8, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing 2. Age greater than or equal to 18 years of age. 3. Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery 4. Spinal or epidural anesthesia Exclusion Criteria: 1. Emergency cesarian delivery 2. Non-reassuring fetal heart rate tracing 3. Less than 18 years of age 4. Multiple gestation (twins, triplets) 5. Presentation other than vertex or breech 6. Less than 36 weeks of gestation 7. General anesthesia

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ISS Device
The ISS Device (commercial and prototype) is used to measure tissue light scattering.

Locations
Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Raydiant Oximetry, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optical signal from maternal and fetal tissues The study of light scattering through maternal/fetal tissue and through maternal tissue alone and newborn tissue alone using a commercial frequency domain oximeter and 2nd generation prototype. Peri-operative
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