Arm Position and Blood Pressure Measurement Accuracy in Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Difference in Systolic and Diastolic Blood Pressure Between Arm Positions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm Unsupported at Side
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
干预措施: Arm Unsupported at Side (Other)
Arm Supported at Heart Level
Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
干预措施: Arm Supported at Heart Level (Other)
Arm Supported on Lap
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
干预措施: Arm Supported on Lap (Other)
结局指标
主要结局
Difference in Systolic and Diastolic Blood Pressure Between Arm Positions
时间窗: At the study visit (single study visit on the day 1 of enrollment)
The within-participant difference in mean systolic and diastolic blood pressure measurements obtained with the arm supported at heart level, supported on the lap, and unsupported at the side. Blood pressure values are calculated as the mean of triplicate measurements for each arm position.
次要结局
- Magnitude of Blood Pressure Differences Between Arm Positions(At the study visit (single study visit on the day 1 of enrollment))
- Variation in Blood Pressure Differences Across Gestational Age(At the study visit (single study visit on the day 1 of enrollment))
- Effect of Arm Position on Blood Pressure by Chronic Hypertension Status(At the study visit (single study visit on the day 1 of enrollment))
- Comparison of Systolic Versus Diastolic Blood Pressure Sensitivity to Arm Position(At the study visit (single study visit on the day 1 of enrollment))
- Blood Pressure Differences by Singleton Versus Multiple Pregnancy(At the study visit (single study visit on the day 1 of enrollment))
研究者
Michal Axelrod
Obstetrician-Gynecologist
Sheba Medical Center