Blood Pressure Cuffs for Hypertension in Pregnancy

Overseen By Paul Fitzgerald, RN,BSN,MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Peripheral arterial disease, Congenital heart disease, Arrhythmia, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

110 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of using Forearm Conical Blood Pressure Cuff and Upper Arm Cylindrical Blood Pressure Cuff for hypertension in pregnancy?

Research suggests that conical cuffs provide more accurate blood pressure readings in people with larger arms, such as those who are obese, compared to standard rectangular cuffs. This accuracy is important for pregnant women, as precise blood pressure measurement is crucial for diagnosing and managing hypertension during pregnancy. ^{1 2 3 4 5}

Is it safe to use conical blood pressure cuffs on humans?

Research indicates that conical blood pressure cuffs are generally safe for use in humans, especially for those with larger arms, as they fit better and provide more accurate readings compared to standard rectangular cuffs. ^{1 3 4 6 7}

How do blood pressure cuffs for hypertension in pregnancy differ from other treatments?

This treatment focuses on using blood pressure cuffs that are appropriately sized for the arm circumference of pregnant women, which is crucial for accurate blood pressure measurement. Unlike standard cuffs, these tailored cuffs help ensure precise readings, which is essential for early diagnosis and management of hypertension (high blood pressure) during pregnancy. ^{2 4 5 8 9}

What is the purpose of this trial?

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

Research Team

Adithya Bhat, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for pregnant women with obesity and high blood pressure. It aims to improve the accuracy of blood pressure measurements, which are crucial for diagnosing hypertensive diseases like preeclampsia. Accurate readings could reduce unnecessary treatments and surgeries.

Exclusion Criteria

I have a history of sickle cell disease.

I am under 18 years old.

I have experienced Raynaud's phenomenon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Baseline blood pressure measurements are taken using both upper arm cylindrical and forearm conical cuffs

1 day

1 visit (in-person)

Sequential Measurement

Sequential paired blood pressure measurements are obtained using both cuffs at specified intervals

1 day

1 visit (in-person)

Follow-up

Participants are monitored for agreement between cuff measurements and patient satisfaction

1 year

Treatment Details

Interventions

• Forearm Conical Blood Pressure Cuff
• Upper Arm Cylindrical Blood Pressure Cuff

Trial Overview The study compares two types of non-invasive blood pressure cuffs: a traditional cylindrical cuff used on the upper arm versus a conical cuff designed for the forearm. The goal is to see which provides more accurate readings in obese pregnant patients.

Participant Groups

Group I: Group 2 Forearm conical cuff Experimental Treatment 1 Intervention

In Group 2 the forearm conical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the upper arm cylindrical cuff is inflated and blood pressure measured.

Group II: Group 1 Upper arm cylindrical cuff Active Control 1 Intervention

In Group 1 the upper arm cylindrical cuff is inflated first and the blood pressure is measured. After one minute has elapsed, the forearm conical cuff is inflated and blood pressure measured.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of the conical cuff and the standard rectangular cuffs. [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

[Comparative study of the indirect measurement of arterial blood pressure in pregnant women with a cuff of correct width and with a standard cuff]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Blood pressure monitoring during pregnancy. Accuracy of portable devices designed for obese patients. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Rectangular cuffs may overestimate blood pressure in individuals with large conical arms. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Only troncoconical cuffs can provide accurate blood pressure measurements in people with severe obesity. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Validation of a conical cuff on the forearm for estimating radial artery blood pressure. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Recommendations for blood pressure measurement in large arms in research and clinical practice: position paper of the European society of hypertension working group on blood pressure monitoring and cardiovascular variability. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Body mass index and blood pressure measurement during pregnancy. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Blood pressure measurement in pregnancy: the effect of arm circumference and sphygmomanometer cuff size. [2020]