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Clinical Trial NCT07405723 for Pregnancy, Blood Pressure Measurement in Pregnancy, Hypertensive Disorder of Pregnancy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Arm Position and Blood Pressure Measurement Accuracy During Pregnancy 300 Randomized Crossover Design Pregnancy

Not yet recruiting
Clinical Trial NCT07405723 is an interventional study for Pregnancy, Blood Pressure Measurement in Pregnancy, Hypertensive Disorder of Pregnancy and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2026 and continue until the study accrues 300 participants. Led by Sheba Medical Center, this study is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on February 25, 2026.
Brief 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. 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 eval...

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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 frequen...Show More
Official Title

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

Conditions
PregnancyBlood Pressure Measurement in PregnancyHypertensive Disorder of Pregnancy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2177-25-SMC
  • 2177-25-SMC (Other Identifier) (Sheba Medical Center IRB)
NCT ID Number
NCT07405723
Start Date (Actual)
2026-03-01
Last Update Posted
2026-02-25
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Blood Pressure Measurement
Pregnancy
Arm Position
Hypertensive Disorders of Pregnancy
Prenatal Care
Blood Pressure Accuracy
Randomized Crossover Trial
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm Supported at Heart Level
Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
Arm Supported at Heart Level
Blood pressure measurements are obtained with the arm supported at heart level while the participant is seated.
ExperimentalArm Supported on Lap
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
Arm Supported on Lap
Blood pressure measurements are obtained with the arm supported on the participant's lap while seated.
ExperimentalArm Unsupported at Side
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
Arm Unsupported at Side
Blood pressure measurements are obtained with the arm unsupported at the participant's side while seated.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
At the study visit (single study visit on the day 1 of enrollment)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
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.
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.
At the study visit (single study visit on the day 1 of enrollment)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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

  • 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
Sheba Medical Center logoSheba Medical Center
Study Responsible Party
Michal Axelrod, Principal Investigator, Obstetrician-Gynecologist, Sheba Medical Center
Study Central Contact
Contact: Michal Axelrod, MD MPH, +97235302697, [email protected]
1 Study Locations in 1 Countries
Sheba Medical Center, Ramat Gan, 5265217, Israel
Michal Axelrod, MD MPH, Contact, +97235302697, [email protected]
Michal Axelrod, MD MPH, Principal Investigator