PregnancyNCT07405723
Arm Position and Blood Pressure Measurement Accuracy During Pregnancy
A study testing Arm Supported at Heart Level, Arm Supported on Lap and Arm Unsupported at Side in people with Pregnancy and Blood Pressure Measurement in Pregnancy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Blood Pressure Measurement in Pregnancy, Hypertensive Disorder of Pregnancy
- What is being tested?
- Arm Supported at Heart Level, Arm Supported on Lap and Arm Unsupported at Side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 5265217
Michal Axelrod, MD MPH, +97235302697, michalaxelrod2805@gmail.com
Michal Axelrod, MD MPH
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Arm Supported at Heart Level, Arm Supported on Lap, Arm Unsupported at Side
- Keywords
- Blood Pressure Measurement, Pregnancy, Arm Position, Hypertensive Disorders of Pregnancy, Prenatal Care, Blood Pressure Accuracy, Randomized Crossover Trial
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm Supported at Heart LevelOther
Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
Arm Supported on LapOther
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
Arm Unsupported at SideOther
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
| Study group | Role | What they receive |
|---|---|---|
| Arm Supported at Heart Level | Experimental | Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated. Receives: Other: Arm Supported at Heart Level |
| Arm Supported on Lap | Experimental | Blood pressure measurements are obtained with the arm supported on the participant's lap while seated. Receives: Other: Arm Supported on Lap |
| Arm Unsupported at Side | Experimental | Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated. Receives: Other: Arm Unsupported at Side |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the study visit (single study visit on the day 1 of enrollment)
Secondary outcomes (5)
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.
Measured: At the study visit (single study visit on the day 1 of enrollment)
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.
Measured: At the study visit (single study visit on the day 1 of enrollment)
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.
Measured: At the study visit (single study visit on the day 1 of enrollment)
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.
Measured: At the study visit (single study visit on the day 1 of enrollment)
Blood Pressure Differences by Singleton Versus Multiple Pregnancy
Comparison of within-participant differences in systolic and diastolic blood pressure between arm positions in singleton and multiple pregnancies.
Measured: At the study visit (single study visit on the day 1 of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start12 Apr 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants undergo blood pressure measurements with the arm placed in multiple positions in a randomized order during a single clinic visit, allowing each participant to serve as her own control.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Axelrod, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405723
- Sponsor's protocol ID
- 2177-25-SMC
- Other IDs
- 2177-25-SMC
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing plans have not yet been determined. Any future data sharing will be subject to institutional policies, ethical approvals, and data protection requirements.
Publications
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.
PubMed 39373998
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Position and Blood Pressure Measurement Accuracy in Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07405723
- Acronym / sponsor ID
- 2177-25-SMC
- Keywords
- Blood Pressure Measurement, Pregnancy, Arm Position, Hypertensive Disorders of Pregnancy, Prenatal Care, Blood Pressure Accuracy, Randomized Crossover Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants undergo blood pressure measurements with the arm placed in multiple positions in a randomized order during a single clinic visit, allowing each participant to serve as her own control.
| Arm | Type | Receives |
|---|---|---|
| Arm Supported at Heart Level | Experimental | Other: Arm Supported at Heart LevelBlood pressure measurements are obtained with the arm supported at heart level while the participant is seated. |
| Arm Supported on Lap | Experimental | Other: Arm Supported on LapBlood pressure measurements are obtained with the arm supported on the participant's lap while seated. |
| Arm Unsupported at Side | Experimental | Other: Arm Unsupported at SideBlood pressure measurements are obtained with the arm unsupported at the participant's side while seated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm Supported at Heart LevelBlood pressure measurements are obtained with the arm supported at heart level while the participant is seated. | Other | Arm Supported at Heart Level |
| Arm Supported on LapBlood pressure measurements are obtained with the arm supported on the participant's lap while seated. | Other | Arm Supported on Lap |
| Arm Unsupported at SideBlood pressure measurements are obtained with the arm unsupported at the participant's side while seated. | Other | Arm Unsupported at Side |
Primary outcome
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.
5 secondary outcomes
Magnitude of Blood Pressure Differences Between Arm Positions
Time frame: 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)
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 Systolic Versus Diastolic Blood Pressure Sensitivity to Arm Position
Time frame: At the study visit (single study visit on the day 1 of enrollment)
Blood Pressure Differences by Singleton Versus Multiple Pregnancy
Time frame: At the study visit (single study visit on the day 1 of enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 39373998Liu 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.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing plans have not yet been determined. Any future data sharing will be subject to institutional policies, ethical approvals, and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm Supported at Heart Level, Arm Supported on Lap and Arm Unsupported at Side in people with Pregnancy and Blood Pressure Measurement in Pregnancy, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Axelrod, MD MPH (+97235302697, michalaxelrod2805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07405723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.