Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
Healthy Volunteers
ID07405723

Arm Position and Blood Pressure Measurement Accuracy in Pregnancy: A Randomized Controlled Trial

Led by Sheba Medical Center · Updated on 2026-04-16

300

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Accurate blood pressure measurement is crucial during pregnancy, especially for diagnosing and managing hypertensive disorders. This study evaluates how different arm positions affect blood pressure readings in pregnant women attending a high-risk pregnancy clinic. It is a randomized crossover trial that includes participants from all three trimesters and stratifies by chronic hypertension status. The goal is to understand the impact of arm position on blood pressure accuracy to improve clinical practice during prenatal care. Participants undergo blood pressure measurements with the arm in three common positions: supported at heart level, supported on the lap, and unsupported at the side. Each participant has multiple measurements taken during a single clinic visit in a randomized order. Measurements are done using an automated device by trained nursing staff after a resting period while the participant is seated comfortably. The study design allows each participant to serve as her own control. During the study visit, blood pressure is carefully recorded in each arm position, and differences in systolic and diastolic readings are analyzed. Secondary analyses examine patterns across gestational ages, chronic hypertension status, and pregnancy type. The study involves minimal risk and does not change standard prenatal care. It aims to provide evidence for best practices in blood pressure measurement during pregnancy and will conclude by the end of 2026.

CONDITIONS

Brief Title

Arm Position and Blood Pressure Measurement Accuracy During Pregnancy

Who Can Participate

Age: 18Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 to 55 years
  • Singleton or multiple viable intrauterine pregnancy
  • Gestational age in first, second, or third trimester at enrollment
  • Ability to sit upright comfortably during blood pressure measurements
  • Ability to understand study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Preexisting significant cardiac disease such as arrhythmias, congenital heart disease, or severe valvular disease
  • Chronic kidney disease with serum creatinine 651.5 mg/dL at enrollment
  • Significant upper limb or shoulder conditions affecting arm positioning or blood pressure measurement (e.g., lymphedema, fractures, prior surgery, arteriovenous fistula)
  • Neurological or musculoskeletal conditions preventing proper positioning
  • Severe preeclampsia, eclampsia, or other acute medical conditions needing immediate intervention
  • Major fetal anomaly
  • Intrauterine fetal demise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 1 day

During a single clinic visit, participants undergo multiple blood pressure measurements with the arm positioned in several commonly used positions to assess measurement accuracy.

1 study visit (in-person)

Trial Site Locations

Total: 1 location

1

Sheba Medical Center

Ramat Gan, Israel, 5265217

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Research Team

M

Michal Axelrod, MD MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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Published Research Related To This Trial