Validation of a blood pressure monitoring system for pregnant women

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

This study is testing a new blood pressure monitoring system for pregnant women to see if it gives accurate readings compared to the traditional method.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mount Carmel Health System (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06002971 on ClinicalTrials.gov

What this trial studies

This study aims to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system by comparing its measurements to those obtained from a traditional auscultatory sphygmomanometer in pregnant patients. Clinical staff will assess patient eligibility based on medical records and collect informed consent before gathering a brief medical history. Serial blood pressure measurements will be taken according to ISO protocol 81060-2 to ensure reliable comparisons between the two methods. The focus is on pregnant individuals beyond the first trimester, including those with normotensive, hypertensive, and pre-eclamptic conditions.

Who should consider this trial

Good fit: Ideal candidates are pregnant women over 12 weeks of gestation, aged 18 or older, who can provide informed consent.

Not a fit: Patients who are not pregnant or those in their first trimester will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood pressure monitoring methods for pregnant women, enhancing maternal and fetal health outcomes.

How similar studies have performed: Other studies have shown success in validating new blood pressure monitoring technologies, suggesting potential for this approach.

Eligibility 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)

Where this trial is running

Columbus, Ohio

• Mount Carmel East — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Robin L Driver, BS

Conditions Pregnancy Related; Pre-Eclampsia; Gestational Hypertension