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CONNEQT Pulse Validation Study

Recruiting
Conditions
Pregnancy Related
Pre-Eclampsia
Gestational Hypertension
Interventions
Device: Blood pressure measurement
Registration Number
NCT06002971
Lead Sponsor
Mount Carmel Health System
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
45
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Pre-EclampsiaBlood pressure measurementPre-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
HypertensiveBlood pressure measurementHypertensive 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
NormotensiveBlood pressure measurementNormotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mount Carmel East

🇺🇸

Columbus, Ohio, United States

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