Pregnancy Clinical Trial
Official title:
Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
NCT number | NCT03504189 |
Other study ID # | CLP1000 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | November 8, 2018 |
Verified date | February 2020 |
Source | Nuvo-Group, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Status | Completed |
Enrollment | 151 |
Est. completion date | November 8, 2018 |
Est. primary completion date | June 27, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Female age between 18-50 - Gestational age > 32 + 0 weeks - Singleton gestation - Ability to understand and sign informed consent Exclusion Criteria: - BMI (Body Mass Index) = 45 and =15 prior pregnancy - Multiple gestation - Uncontrolled Hypertension - Fetal Anomaly - Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.) - Subjects with implanted electronic devices (pacemaker, defibrillator, etc.) - Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study |
Country | Name | City | State |
---|---|---|---|
Germany | Heidelberg University Womens Hospital | Heidelberg | |
Israel | Hadassah-Hebrew University Medical Center | Jerusalem | |
United States | Eastern Virginia Medical School | Norfolk | Virginia |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Nuvo-Group, Ltd. |
United States, Germany, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Measures | Evaluate device related adverse events | Through study completion, an average of 1 hour | |
Primary | Fetal Heart Rate | Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG) | 30 Minutes | |
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) | 30 MInutes | |
Secondary | Uterine Contractions | Compare uterine contractions from Pregsense™ versus CTG. | 30 Minutes |
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