- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405723
Arm Position and Blood Pressure Measurement Accuracy During Pregnancy
Arm Position and Blood Pressure Measurement Accuracy in Pregnancy: A Randomized Controlled 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michal Axelrod, MD MPH
- Phone Number: +97235302697
- Email: michalaxelrod2805@gmail.com
Study Locations
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-
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Ramat Gan, Israel, 5265217
- Recruiting
- Sheba Medical Center
-
Contact:
- Michal Axelrod, MD MPH
- Phone Number: +97235302697
- Email: michalaxelrod2805@gmail.com
-
Principal Investigator:
- Michal Axelrod, MD MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm Supported at Heart Level
Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
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Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
|
|
Experimental: Arm Supported on Lap
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
|
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
|
|
Experimental: Arm Unsupported at Side
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
|
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Systolic and Diastolic Blood Pressure Between Arm Positions
Time Frame: 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.
|
At the study visit (single study visit on the day 1 of enrollment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnitude of Blood Pressure Differences Between Arm Positions
Time Frame: At the study visit (single study visit on the day 1 of enrollment)
|
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.
|
At the study visit (single study visit on the day 1 of enrollment)
|
|
Variation in Blood Pressure Differences Across Gestational Age
Time Frame: At the study visit (single study visit on the day 1 of enrollment)
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Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions across trimester-specific cohorts of pregnancy.
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At the study visit (single study visit on the day 1 of enrollment)
|
|
Effect of Arm Position on Blood Pressure by Chronic Hypertension Status
Time Frame: At the study visit (single study visit on the day 1 of enrollment)
|
Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions among participants with and without preexisting chronic hypertension.
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At the study visit (single study visit on the day 1 of enrollment)
|
|
Comparison of Systolic Versus Diastolic Blood Pressure Sensitivity to Arm Position
Time Frame: At the study visit (single study visit on the day 1 of enrollment)
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Assessment of differences in the magnitude of arm position-related variation between systolic and diastolic blood pressure measurements within participants.
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At the study visit (single study visit on the day 1 of enrollment)
|
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Blood Pressure Differences by Singleton Versus Multiple Pregnancy
Time Frame: At the study visit (single study visit on the day 1 of enrollment)
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Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions in singleton and multiple pregnancies.
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At the study visit (single study visit on the day 1 of enrollment)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2177-25-SMC (Other Identifier: Sheba Medical Center IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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