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This is a multicenter, prospective, investigational device study designed to evaluate:
The safety, feasibility, and accuracy of the device, when used by pregnant individuals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Ultrasound users | Other | Single Arm home ultrasound in pregnant women users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsenmore ES home ultrasound device | Device | Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of device derived presence or absence of fetal cardiac activity to ground truth | The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan) | Test to be conducted during week 14-38 of pregnancy |
| Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth | Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan) | Test to be conducted during week 14-38 of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to assess fetal presentation from device derived input will be compared to the ground truth | Whether fetal presentation could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan) | Test to be conducted during week 14-38 of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reem Abu-Rustum, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Fetal Medicine and Women's Ultrasound | Los Angeles | California | 90048 | United States | ||
| University of Florida College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG) | ||
| 26238329 | Background | Abuhamad A, Zhao Y, Abuhamad S, Sinkovskaya E, Rao R, Kanaan C, Platt L. Standardized Six-Step Approach to the Performance of the Focused Basic Obstetric Ultrasound Examination. Am J Perinatol. 2016 Jan;33(1):90-8. doi: 10.1055/s-0035-1558828. Epub 2015 Aug 3. |
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| Ability to assess placental location from device derived input will be compared to the ground truth |
Whether placental location could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan) |
| Test to be conducted during week 14-38 of pregnancy |
| Ability to detect fetal movement from device derived input will be compared to the ground truth | Whether fetal movement could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan) | Test to be conducted during week 14-38 of pregnancy |
| Ability to detect fetal breathing from device derived input will be compared to the ground truth | Whether fetal breathing could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan) | Test to be conducted during week >27-38 of pregnancy |
| Gainesville |
| Florida |
| 32601-0294 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mount Sinai Hospital System | New York | New York | 10029 | United States |