Arm Position and Blood Pressure Measurement Accuracy During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorSheba Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Arm Supported at Heart Level
Other interventionBlood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
Arm Supported on Lap
Other interventionBlood pressure measurements are obtained with the arm supported on the participant's lap while seated.
Arm Unsupported at Side
Other interventionBlood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Arm Supported at Heart LevelExperimental treatment 1 intervention
Group B: Arm Supported on LapExperimental treatment 1 intervention
Group C: Arm Unsupported at SideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in Systolic and Diastolic Blood Pressure Between Arm Positions
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.
Time frame
At the study visit (single study visit on the day 1 of enrollment)Secondary outcomes
1
Magnitude of Blood Pressure Differences Between Arm Positions
The absolute difference in mean systolic and diastolic blood pressure measurements between each pair of arm positions (supported at heart level, supported on the lap, unsupported at the side), calculated within each participant.
Time frame
At the study visit (single study visit on the day 1 of enrollment)2
Variation in Blood Pressure Differences Across Gestational Age
Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions across trimester-specific cohorts of pregnancy.
Time frame
At the study visit (single study visit on the day 1 of enrollment)3
Effect of Arm Position on Blood Pressure by Chronic Hypertension Status
Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions among participants with and without preexisting chronic hypertension.
Time frame
At the study visit (single study visit on the day 1 of enrollment)4
Comparison of Systolic Versus Diastolic Blood Pressure Sensitivity to Arm Position
Assessment of differences in the magnitude of arm position-related variation between systolic and diastolic blood pressure measurements within participants.
Time frame
At the study visit (single study visit on the day 1 of enrollment)Sponsors and contacts
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Source ClinicalTrials.gov