RecruitingNot ApplicableNCT06466161

Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients


Sponsor

Northwestern University

Enrollment

110 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures: * Agreement between conical and cylindrical cuff systolic blood pressure across groups * Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures: • Agreement between conical and cylindrical cuff mean arterial pressure


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing blood pressure readings taken at two different spots on the arm — the forearm (conical shape) versus the upper arm (cylindrical shape) — in pregnant women to determine which location gives more accurate measurements during labor. **You may be eligible if...** - You are a woman 18 or older who is pregnant and in labor - Your BMI is 20 or higher - You may or may not have a blood pressure condition such as gestational hypertension or preeclampsia **You may NOT be eligible if...** - You have significant peripheral artery disease causing unequal blood pressure between your arms - You have congenital heart disease, a serious heart rhythm problem, or a pacemaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUpper Arm Cylindrical Blood Pressure Cuff

In Group 1, the upper arm cylindrical cuff is inflated first, followed by inflation of the forearm conical cuff.

DEVICEForearm Conical Blood Pressure Cuff

In Group 2, the forearm conical cuff is inflated first, followed by inflation of the upper arm cylindrical cuff.


Locations(1)

Prentice Women's Hospital

Chicago, Illinois, United States

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NCT06466161


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