Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06466161

Evaluation of Agreement Between Conical Forearm and Cylindrical Upper Arm Blood Pressure Cuffs in Pregnant Patients

Led by Northwestern University · Updated on 2026-05-26

110

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of two types of non-invasive blood pressure (NIBP) cuffs in pregnant women, specifically focusing on hypertensive disease during pregnancy. This condition is diagnosed based on strict blood pressure thresholds, and improving measurement accuracy by even 5 mm Hg could significantly impact diagnosis and management. The study aims to compare a conical forearm cuff with a traditional cylindrical upper arm cuff, especially in morbidly obese women, where standard measurements can be less accurate. This research is important due to the rising rates of obesity and hypertensive disease among pregnant women in the United States and is sponsored by Northwestern University. After consenting, participants are assigned to one of four groups based on their blood pressure and obesity status: normotensive/non-obese, normotensive/obese, hypertensive/non-obese, or hypertensive/obese. Blood pressure measurements are taken using both a cylindrical upper arm cuff and a conical forearm cuff. Measurements are collected sequentially at multiple time points, with the order of cuff use randomized. Body measurements such as weight, height, arm circumference, and length are recorded. The study includes six sets of paired blood pressure readings during labor and delivery. Antihypertensive treatment decisions are made by obstetrical providers based on standard protocols and cylindrical cuff readings. Participants will undergo body and limb measurements, followed by multiple paired blood pressure readings in a sitting position during labor or induction. Both cuffs are used alternately, with measurements taken every few minutes over a period of time. Researchers will assess the agreement between systolic, diastolic, and mean arterial pressures measured by the two cuff types. Patient satisfaction with each cuff will also be recorded. The study is expected to last about one year for each participant, with safety and treatment managed by the clinical care team throughout the process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Body mass index (BMI) of 20 kg/m2 or greater
  • Present to Labor and Delivery for spontaneous labor or induction
  • With or without diagnosis of gestational hypertension, preeclampsia, or chronic hypertension with super-imposed preeclampsia
Not Eligible

You will not qualify if you...

  • Significant peripheral arterial disease causing at least a 10 mm Hg blood pressure difference between arms
  • History of repaired or unrepaired congenital heart disease
  • History of significant arrhythmia
  • 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 younger than 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day during labor or induction

Participants have blood pressure measured using two different cuffs (upper arm cylindrical and forearm conical) in a randomized sequence during labor or induction. Measurements include baseline and sequential paired readings over approximately 10 minutes, followed by additional readings every 15 minutes.

1 in-person visit with multiple sequential blood pressure measurements over approximately 1 hour

Long-term Monitoring

Duration - Up to 1 year

Participants' blood pressure readings and patient satisfaction scores are monitored for up to 1 year to assess agreement between the two cuff types.

Follow-up as determined by clinical care and study assessments

Trial Site Locations

Total: 1 location

1

Prentice Women's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

Loading map...

Research Team

A

Adithya Bhat, MD

P

Paul Fitzgerald, RN,BSN,MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

"Smart Family Doctor" Assisted Comprehensive Management of S...

Post Coronary Artery Bypass Grafting

Actively Recruiting

1 location

The PILI 'Aina Project to Improve Cardiometabolic Health in...

Type 2 Diabetes

Actively Recruiting

2 locations

Vascular Function in Health and Disease: Rehabilitation for ...

Chronic Obstructive Pulmonary Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial