Arm Position and Blood Pressure Measurement Accuracy During Pregnancy

Официальное название

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

Обзор

Accurate blood pressure measurement is essential during pregnancy, as blood pressure readings guide clinical decisions related to the diagnosis and management of hypertensive disorders of pregnancy. Clinical guidelines recommend measuring blood pressure with the arm supported at heart level; however, in routine practice, blood pressure is often measured with the arm in non-standard positions. This study aims to evaluate how different arm positions affect blood pressure measurements in pregnant women. Pregnant women attending a high-risk pregnancy clinic will undergo blood pressure measurements with the arm placed in several commonly used positions, including supported at heart level, supported on the lap, and unsupported at the side. Each participant will have multiple measurements taken during a single clinic visit. The study is designed as a randomized crossover trial with stratification by trimester and chronic hypertension status, allowing each participant to serve as her own control. Participants will be enrolled across all three trimesters of pregnancy, and results will be analyzed separately for each trimester. The primary outcome is the difference in systolic and diastolic blood pressure measurements between arm positions. The findings of this study may help improve the accuracy of blood pressure measurement during pregnancy and inform clinical practice regarding optimal measurement techniques.

Подробное описание

Blood pressure measurement is a routine and essential component of prenatal care and plays a central role in the diagnosis and management of hypertensive disorders of pregnancy. International and national guidelines recommend measuring blood pressure with the patient seated, after a period of rest, and with the arm supported at heart level. Despite these recommendations, blood pressure in clinical practice is frequently measured with the arm placed in non-standard positions, which may lead to inaccurate readings and potential misclassification of blood pressure status.

This study is designed to assess the effect of arm position on blood pressure measurements in pregnant women. This is a single prospective randomized crossover trial conducted across all three trimesters of pregnancy. Randomization of arm position order is performed using a computerized block randomization system with stratification by trimester (first, second, third) and chronic hypertension status.

Participants are enrolled during routine visits to a high-risk pregnancy clinic and are assigned to a trimester-specific cohort based on gestational age at the time of enrollment. During a single clinic visit, each participant undergoes multiple blood pressure measurements with the arm positioned in several commonly used positions: supported on a desk at heart level, supported on the lap, and unsupported at the side. To account for natural variability in blood pressure measurements, an additional set of measurements with the arm supported at heart level is obtained. Each participant serves as her own control within the randomized crossover design.

Blood pressure measurements are performed by trained nursing staff using a clinically approved automated blood pressure device, following a standardized measurement protocol. All measurements are obtained after a resting period and while the participant is seated comfortably.

Participants are recruited across all three trimesters, and analyses are conducted separately by trimester. The primary outcome is the difference in systolic and diastolic blood pressure measurements between arm positions. Secondary analyses evaluate the magnitude and pattern of blood pressure differences across gestational ages and relevant clinical subgroups.

This study involves minimal risk and does not alter standard clinical care. The results are intended to improve understanding of how arm positioning influences blood pressure measurements during pregnancy and to inform best practices for accurate blood pressure assessment in prenatal care.

Вмешательства

• Другое Arm Supported at Heart Level
  Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
• Другое Arm Supported on Lap
  Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
• Другое Arm Unsupported at Side
  Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.

Первичные конечные точки

• Difference in Systolic and Diastolic Blood Pressure Between Arm Positions [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]

Вторичные конечные точки (5)

• Magnitude of Blood Pressure Differences Between Arm Positions [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]
• Variation in Blood Pressure Differences Across Gestational Age [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]
• Effect of Arm Position on Blood Pressure by Chronic Hypertension Status [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]
• Comparison of Systolic Versus Diastolic Blood Pressure Sensitivity to Arm Position [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]
• Blood Pressure Differences by Singleton Versus Multiple Pregnancy [Срок оценки: At the study visit (single study visit on the day 1 of enrollment)]

Критерии участия

Критерии включения

• Pregnant women aged 18 to 55 years
• Singleton or multiple viable intrauterine pregnancy
• Gestational age corresponding to first, second, or third trimester at the time of enrollment
• Ability to sit upright comfortably for the duration of blood pressure measurements
• Ability to understand the study procedures and provide written informed consent

Критерии исключения

• Preexisting significant cardiac disease (e.g., arrhythmias, congenital heart disease, severe valvular disease)
• Chronic kidney disease defined as serum creatinine ≥1.5 mg/dL at enrollment
• Significant upper limb or shoulder conditions that may affect 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 requiring immediate intervention
• Major fetal anomaly
• Intrauterine fetal demise

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Израиль · 1 центр

• Sheba Medical Center — Ramat Gan

Публикации

• Liu H, Zhao D, Sabit A, Pathiravasan CH, Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Arm Position and Blood Pressure Readings: The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1436-1442. doi: 10.1001/jamainternmed.2024.5213. PMID 39373998

Идентификаторы

NCT: NCT07405723 · 2177-25-SMC · 2177-25-SMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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