An observational study in Pregnancy Related, Pre-Eclampsia and Gestational Hypertension, sponsored by Mount Carmel Health System. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Mount Carmel Health System · Observational
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.
Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.
All Groups:
Normotensive:
1. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)
Hypertensive:
Pre-Eclampsia:
Normotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg
Device: Blood pressure measurement
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
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
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
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.
Time frame: Up to 60 minutes
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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