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COVID-19
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This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic | This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP) |
| |
| Labor and Delivery | This group is in active labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raydiant Oximetry Sensing System | Device | The investigational device is used to record fetal pulse signals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal signal integrity | Integrity of the fetal signal relative to background maternal signal and biologic/electronic noise, and related to fetal position, presentation and the depth of the fetus from maternal skin. | During NST, BPP, or active labor |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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Women undergoing their scheduled visit to the MFM clinic for a NST/BPP or in latent labor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D005316 | Fetal Distress |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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