Fetal Distress
Conditions
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.
Interventions
DEVICEISS Device
The ISS Device (commercial and prototype) is used to measure tissue light scattering.
Sponsors
Raydiant Oximetry, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed