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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06466161
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Apr 29, 2025
Status verified
Apr 2026
Primary completion
Jul 30, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Group 1 Upper arm cylindrical cuff
    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.
  • Experimental: Group 2 Forearm conical cuff
    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.

Primary Outcome Measure

Agreement between conical and cylindrical cuff systolic blood pressure as measured by mean absolute deviance [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Prentice Women's HospitalChicagoIllinois60611
Paul Fitzgerald, RN,BSN,MS
[email protected]
312-926-1064
Adithya Bhat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Prentice Women's Hospital· Chicago, IL

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