RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Evaluation of the Agreement Between Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

Quick Facts

Study Start:2025-03-18
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06466161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women who are 18 years of age or older with a
  2. * Body mass index (BMI) of 20 kg/m2 or greater
  3. * 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
  1. * Significant peripheral arterial disease resulting in at least a 10 mm Hg blood pressure difference between both arms
  2. * History of repaired or unrepaired congenital heart disease
  3. * History of significant arrythmia
  4. * History of pacemaker or implantable cardioverter defibrillator placement
  5. * History of sickle cell disease
  6. * History of Raynaud's phenomenon on any extremity
  7. * History of lymph node dissection of either upper extremity
  8. * Patients who are less than 18 years of age

Contacts and Locations

Study Contact

Adithya Bhat, MD
CONTACT
312-472-3585
adithya.bhat@northwestern.edu
Paul Fitzgerald, RN,BSN,MS
CONTACT
312-695-1064
p-fitzgerald2@northwestern.edu

Principal Investigator

Adithya Bhat, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Prentice Women's Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Adithya Bhat, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hypertension in Pregnancy
  • Hypertension
  • Obesity