Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Raydiant Oximetry, Inc.4 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Fetal Distress

Interventions

ISS DeviceDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Peri-operative

Data from ClinicalTrials.gov

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