CONNEQT Pulse Validation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population

Conditions
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Pregnancy Related, Pre-Eclampsia, Gestational Hypertension

Intervention / Treatment
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* Device: Blood pressure measurement


Participation Criteria
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Eligibility Criteria
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All Groups: Able to provide informed consent Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation) 18 years of age, or older Normotensive: 1. Systolic blood pressure <140 mmHg (18,66 kPa) and diastolic blood pressure <90 mmHg (12 kPa) Hypertensive: Without proteinuria >300 mg in 24 h; and With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa) Pre-Eclampsia: With proteinuria >300 mg in 24 h; and With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normotensive<br>Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg | Device: Blood pressure measurement<br>* Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.<br>|
| Hypertensive<br>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 | Device: Blood pressure measurement<br>* Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.<br>|
| Pre-Eclampsia<br>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 | Device: Blood pressure measurement<br>* Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |