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This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PregSense™ | Experimental | PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PregSense™ | Device | PregSense™ wearable device will be applied for maternal-fetal monitoring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Rate | Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG) | 30 Minutes |
| Maternal Heart Rate | Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG) | 30 MInutes |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine Contractions | Compare uterine contractions from Pregsense™ versus CTG. | 30 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measures | Evaluate device related adverse events | Through study completion, an average of 1 hour |
Inclusion Criteria:
Exclusion Criteria:
Pregnant females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Eastern Virginia Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33345967 | Derived | Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | "PregSense™ and Cardiotocopraphy (CTG)" | PregSense™ WSB then was applied by the authorized study personnel to the maternal abdominal area, not before cleaning the maternal abdomen with a damp cloth, then drying the abdomen. Before initiating the recording session, a valid signal is to be obtained. An authorized study personnel applied the CTG transducers and confirmed fetal heart rate detection according to the standard of care procedure. If a valid signal was detected, a 30-minute session initiated, recording both systems simultaneously in a synchronized method (PregSense™ and CTG). Following the completion of the sessions, the authorized study personnel removed both monitoring systems from the maternal abdomen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PregSense™ | PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fetal Heart Rate | Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG) | Posted | Mean | Standard Deviation | bpm | 30 Minutes |
|
|
30 minutes during Non stress test (NST)
No adverse events reported during the trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PregSense™ | PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical | Nuvo Group | +972-3-6242266 | 1630 | adar.shani@nuvocares.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2018 | Jan 13, 2019 | Prot_SAP_000.pdf |
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Open Label
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| Cardiotocopraphy (CTG) |
| Device |
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring |
|
| Norfolk |
| Virginia |
| 23507 |
| United States |
| Heidelberg University Womens Hospital | Heidelberg | Germany |
| Hadassah-Hebrew University Medical Center | Jerusalem | Israel |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Participants |
|
|
| Primary | Maternal Heart Rate | Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG) | Posted | Mean | Standard Deviation | bpm | 30 MInutes |
|
|
|
| Secondary | Uterine Contractions | Compare uterine contractions from Pregsense™ versus CTG. | Uterine Contraction information was eventually not collected AT ALL, therefore no population to describe. | Posted | 30 Minutes |
|
|
| Other Pre-specified | Safety Measures | Evaluate device related adverse events | Posted | Count of Participants | Participants | Through study completion, an average of 1 hour |
|
|
|
| 0 |
| 147 |
| 0 |
| 147 |
| 0 |
| 147 |
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