Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT06466161

Conditions

Hypertension in Pregnancy

Hypertension

Obesity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Upper Arm Cylindrical Blood Pressure Cuff

Forearm Conical Blood Pressure Cuff

Study Details

Brief 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

Conditions

Hypertension in Pregnancy

Hypertension

Obesity

Study ID

NCT06466161

Start date

Apr 29, 2025

Status verified date

Apr, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Upper Arm Cylindrical Blood Pressure Cuff

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

Forearm Conical Blood Pressure Cuff

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

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

Central Contacts and Locations

Central contacts

Adithya Bhat, MD

312-472-3585adithya.bhat@northwestern.edu

Paul Fitzgerald, RN,BSN,MS

312-695-1064p-fitzgerald2@northwestern.edu

Locations

Prentice Women's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Paul Fitzgerald, RN,BSN,MS

312-926-1064p-fitzgerald2@northwestern.edu

Principal Investigator:

Adithya Bhat, MD

More Information

Sponsor

Northwestern University

Last update posted

May 26, 2026

Last verified

Apr, 2026

Keywords

  • Hypertension
  • Conical Blood Pressure Cuff
  • Cylindrical Blood Pressure Cuff
  • Pregnancy
  • Obesity
  • Non invasive blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-26.