Gestational Hypertension, Pre-Eclampsia, Pregnancy Related
Conditions
Brief summary
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
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.
Interventions
DEVICEBlood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
Sponsors
Mount Carmel Health System
AtCor Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All Groups: 1. Able to provide informed consent 2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation) 3. 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: 1. Without proteinuria \>300 mg in 24 h; and 2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa) Pre-Eclampsia: 1. With proteinuria \>300 mg in 24 h; and 2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings. | Up to 60 minutes | 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. |
Countries
United States
Outcome results
None listed