Fetal Distress Clinical Trial
Official title:
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
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 |
Verified date | August 2021 |
Source | Raydiant Oximetry, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is being conducted to study light scattering properties of maternal-fetal tissue.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Raydiant Oximetry, Inc. |
United States,
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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