Blood Pressure Cuffs for Hypertension in Pregnancy

Recruiting in Palo Alto (17 mi)

Overseen byAdithya Bhat, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for pregnant women with obesity and high blood pressure. It aims to improve the accuracy of blood pressure measurements, which are crucial for diagnosing hypertensive diseases like preeclampsia. Accurate readings could reduce unnecessary treatments and surgeries.

Inclusion Criteria

I am a woman over 18, my BMI is 20 or more, and I am in labor with or without high blood pressure conditions.

Exclusion Criteria

I have a history of sickle cell disease.

I am under 18 years old.

I have experienced Raynaud's phenomenon.

+5 more

Participant Groups

The study compares two types of non-invasive blood pressure cuffs: a traditional cylindrical cuff used on the upper arm versus a conical cuff designed for the forearm. The goal is to see which provides more accurate readings in obese pregnant patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2 Forearm conical cuffExperimental Treatment1 Intervention

In Group 2 the forearm conical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the upper arm cylindrical cuff is inflated and blood pressure measured.

Group II: Group 1 Upper arm cylindrical cuffActive Control1 Intervention

In Group 1 the upper arm cylindrical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the forearm conical cuff is inflated and blood pressure measured.