Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06466161

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionHypertension in Pregnancy, Hypertension, Obesity

Full registry criteria

Inclusion Criteria: * Women who are 18 years of age or older with a * Body mass index (BMI) of 20 kg/m2 or greater * Present to Labor and Delivery with or without a diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia, in spontaneous labor or for induction of labor Exclusion Criteria: * Significant peripheral arterial disease resulting in at least a 10 mm Hg blood pressure difference between both arms * History of repaired or unrepaired congenital heart disease * History of significant arrythmia * History of pacemaker or implantable cardioverter defibrillator placement * History of sickle cell disease * History of Raynaud's phenomenon on any extremity * History of lymph node dissection of either upper extremity * Patients who are less than 18 years of age

Treatments and study arms

Upper Arm Cylindrical Blood Pressure Cuff

Device

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

Forearm Conical Blood Pressure Cuff

Device

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

Primary outcomes

Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute devianceThrough study completion, an average of 1 year

Agreement between conical and cylindrical cuff systolic blood pressure across 4 distinct subject groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.

Agreement between conical and cylindrical cuff diastolic blood pressure as measured by mean absolute devianceThrough study completion, an average of 1 year

Agreement between conical and cylindrical cuff diastolic blood pressure across 4 distinct groups: (1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Prentice Women's Hospital🇺🇸 Chicago, Illinois, United States

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Paul Fitzgerald, RN,BSN,MSContact

Email · Call 312-926-1064

Adithya Bhat, MDPrincipal Investigator