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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new blood pressure cuffs to determine if they provide more accurate readings for pregnant women with high blood pressure. It compares traditional upper arm cylindrical cuffs with newer forearm conical cuffs, aiming to improve diagnosis and treatment. Pregnant women with a BMI of 20 or higher who may experience high blood pressure issues, such as gestational hypertension or preeclampsia, are suitable candidates for this trial. The goal is to find better ways to manage blood pressure during pregnancy, especially for those who are morbidly obese. As an unphased trial, this study allows participants to contribute to innovative research that could enhance prenatal care.

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 prior data suggests that these blood pressure cuffs are safe for use in pregnant women?

Research has shown that using different blood pressure cuffs can affect the accuracy of readings, particularly in pregnant women. One study found that a standard cuff could incorrectly diagnose high blood pressure in an additional 5% to 7% of women, depending on arm size. As a result, some women might be mistakenly told they have high blood pressure.

The new conical cuff, currently under testing, is designed to fit the arm better and provide more accurate readings. However, these conical cuffs have not been fully tested for accuracy and reliability in pregnant women, so complete evidence on their effectiveness is not yet available.

No specific safety concerns have been reported for using different types of blood pressure cuffs. Generally, they are non-invasive and considered safe. The goal of using the conical cuff is to improve blood pressure measurements, aiding in more informed medical decisions and avoiding unnecessary treatments or procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different types of blood pressure cuffs to get the most accurate readings for pregnant women with hypertension. Unlike the standard upper arm cylindrical cuffs, which are commonly used, this trial also examines forearm conical cuffs to see if they provide more reliable blood pressure measurements in this specific group. By comparing these two cuff types, the study aims to determine the best method for monitoring blood pressure in pregnant women, potentially leading to better management of hypertension during pregnancy.

What evidence suggests that these blood pressure cuffs are effective for diagnosing hypertension in pregnancy?

This trial will compare the effectiveness of different blood pressure cuffs for pregnant women with hypertension. Research has shown that conical blood pressure cuffs provide more accuracy for individuals with larger arms, such as those who are obese. This accuracy is crucial to avoid unnecessary treatments and procedures during pregnancy. Studies have found that using the correct size and type of cuff leads to better management of high blood pressure in pregnant women. More accurate readings mean fewer women receive incorrect diagnoses and treatments for high blood pressure, reducing the need for early delivery or cesarean sections. Therefore, using the right cuff can improve care for many pregnant women with high blood pressure. Participants in this trial will be assigned to use either the upper arm cylindrical cuff first or the forearm conical cuff first to determine which provides more accurate blood pressure readings. ^{5 6 7 8 9}

Who Is on the Research Team?

Adithya Bhat, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10392017/

An evaluation of the efficacy and the safety of home blood ... Our analysis revealed a superiority of HBPM in reducing the risk of induction of labor, and postpartum readmission (P = 0.02, and 0.01 ...

2. withpower.com withpower.com/trial/phase-obesity-7-2024-02d96

Blood Pressure Cuffs 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 ...

3. academic.oup.com academic.oup.com/ajh/article/38/1/12/7811875

Blood Pressure Cuff Sizes for Pregnant Women in the United ... Among US pregnant women, recommended cuff sizes were: 17.9% small adult, 57.0% adult, and 25.1% for large or XL.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2807853

Effects of Cuff Size on the Accuracy of Blood Pressure ... The primary outcome was the difference in the mean SBP and diastolic BP (DBP) obtained with a regular BP cuff compared with an appropriate BP ...

5. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.22059

Detection and Control of Pregnancy Hypertension Using ... In this study, data from the first adequately powered randomized controlled trials of blood pressure self-monitoring in pregnancy have shown it ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210778918301442

Arm and finger measurements in the third trimester Trono-conical cuffs, which avoid the “gap” problem, have not been validated in pregnant women.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4989754/

Blood pressure measurement in pregnancy: the effect of ... Compared with a large cuff, a standard cuff will diagnose hypertension in an extra 5% of women with AC ≤33 cm and an extra 7% of women with AC >33 cm.

9. nature.com nature.com/articles/s41440-025-02304-x

Lack of validated blood pressure devices for use in ... To confirm accuracy among pregnant women, automated devices should undergo additional validation testing because of haemodynamic changes induced ...