Trials / Completed
CompletedNCT03504189
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Nuvo-Group, Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PregSense™ | PregSense™ wearable device will be applied for maternal-fetal monitoring |
| DEVICE | Cardiotocopraphy (CTG) | Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2018-06-27
- Completion
- 2018-11-08
- First posted
- 2018-04-20
- Last updated
- 2020-02-18
- Results posted
- 2020-02-18
Locations
4 sites across 3 countries: United States, Germany, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03504189. Inclusion in this directory is not an endorsement.