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NCT06466161 · ClinicalTrials.gov registry record · NA
Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
A NA study of Obesity and Hypertension, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06466161: Recruiting NA study of Obesity and Hypertension, sponsored by Northwestern University.
NCT06466161 is a NA study of Obesity and Hypertension that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 110 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06466161, a NA study of Obesity and Hypertension, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Agreement between conical and cylindrical cuff systolic blood pressure across 4 distinct subject groups:(1) normotensive/non-obese (2) normotensive/obese (3) hypertensive/non-obese and (4) hypertensive/obese.
Conditions Studied
Interventions
- DEVICE Upper Arm Cylindrical Blood Pressure Cuff
- DEVICE Forearm Conical Blood Pressure Cuff
Study Locations (1)
Illinois
- Prentice Women's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2027-09-01 |
| Phase | NA |
What NCT06466161 shows while recruiting
NCT06466161 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Upper Arm Cylindrical Blood Pressure Cuff is the first listed.
NCT06466161 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06466161 about?
NCT06466161 is a clinical study titled "Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients". 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 refle...
What is the current status of trial NCT06466161?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2025-04-29. Estimated completion is 2027-09-01.
What conditions does trial NCT06466161 study?
This clinical trial studies the following conditions: Obesity, Hypertension, Hypertension in Pregnancy.
What interventions are being tested in trial NCT06466161?
The interventions under investigation include: Upper Arm Cylindrical Blood Pressure Cuff (DEVICE), Forearm Conical Blood Pressure Cuff (DEVICE).
Who is sponsoring clinical trial NCT06466161?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06466161 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06466161's enrollment target sits among peer trials
110 458th of 1053 higher than 594 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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