Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
Terminated
- Conditions
- Fetal Distress
- Registration Number
- NCT04081584
- Lead Sponsor
- Raydiant Oximetry, Inc.
- 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 are having a scheduled C-section.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Optical signal from maternal and fetal tissues Peri-operative 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States