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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares blood pressure readings from a cone-shaped cuff on the forearm and a tube-shaped cuff on the upper arm. It is for pregnant women age 18 or older who come to Labor and Delivery in labor or to have labor started, with or without high blood pressure.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Body mass index (BMI), a measure based on height and weight, of 20 or higher.
  • Come to Labor and Delivery in labor or to have labor started. You may have high blood pressure or preeclampsia, a pregnancy condition linked to high blood pressure, but neither is required.

Who can't join

  • Artery disease that reduces blood flow and causes a blood pressure difference of at least 10 mm Hg between your arms.
  • A heart problem present at birth, whether repaired or not.
  • A history of a serious uneven heartbeat.
  • A pacemaker or implanted defibrillator, devices that help control your heartbeat.
  • Sickle cell disease, an inherited blood disorder.
  • Raynaud's, a condition that limits blood flow, in any arm or leg.
  • Surgery to remove lymph nodes from either arm.
  • Younger than 18.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

IL