NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
| NCT ID | NCT06466161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Hypertension in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-04-29 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Adithya Bhat, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06466161 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hypertension in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06466161 currently recruiting?
Yes, NCT06466161 is actively recruiting participants. Contact the research team at adithya.bhat@northwestern.edu for enrollment information.
Where is the NCT06466161 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06466161 clinical trial?
NCT06466161 is sponsored by Northwestern University. The principal investigator is Adithya Bhat, MD at Northwestern University. The trial plans to enroll 110 participants.