Status:
TERMINATED
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
Lead Sponsor:
Raydiant Oximetry, Inc.
Conditions:
Fetal Distress
Eligibility:
FEMALE
18+ years
Brief Summary
This study is being conducted to study light scattering properties of maternal-fetal tissue.
Detailed 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 ar...
Eligibility Criteria
Inclusion
- 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
- Age greater than or equal to 18 years of age.
- Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
- Spinal or epidural anesthesia
Exclusion
- Emergency cesarian delivery
- Non-reassuring fetal heart rate tracing
- Less than 18 years of age
- Multiple gestation (twins, triplets)
- Presentation other than vertex or breech
- Less than 36 weeks of gestation
- General anesthesia
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04081584
Start Date
July 1 2019
End Date
June 8 2021
Last Update
August 11 2021
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111