CONNEQT Pulse Validation Study

Terminated

• Conditions: Pregnancy Related; Pre-Eclampsia; Gestational Hypertension

• 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.

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-16
• Study Start: 2023-08-21
• Study First Posted: 2023-08-21
• Status Verified: 2024-10
• Primary Completion: 2025-06-03
• Study Completion: 2025-06-03
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mount Carmel East; 🇺🇸 Columbus, Ohio, United States