NCT06466161 · Northwestern University
Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations