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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm home ultrasound in pregnant women require BPP | Other | Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsenmore ES home ultrasound device | Device | Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider |
| Measure | Description | Time Frame |
|---|---|---|
| Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being | Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Assess preliminary effectiveness and compare participant results to standard of care BPP | The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP | One day |
| Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Peahl, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Patients will answer a questionnaire about their experience using Pulsenmore device |
| One day |