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Unable to recruit intended patient population
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| Name | Class |
|---|---|
| AtCor Medical, Inc. | INDUSTRY |
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The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normotensive | Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg |
| |
| Hypertensive | Hypertensive pregnant patients beyond the first trimester: i) without proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg |
| |
| Pre-Eclampsia | Pre-eclampsia patients beyond the first trimester: i) with proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure measurement | Device | Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings. | Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol. | Up to 60 minutes |
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All Groups:
Normotensive:
1. Systolic blood pressure <140 mmHg (18,66 kPa) and diastolic blood pressure <90 mmHg (12 kPa)
Hypertensive:
Pre-Eclampsia:
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Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Carmel East | Columbus | Ohio | 43213 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010808 | Physical Examination |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |