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De klinische studie NCT07405723 voor Zwangerschap, Blood Pressure Measurement in Pregnancy, Hypertensieve aandoening tijdens de zwangerschap is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Arm Position and Blood Pressure Measurement Accuracy During Pregnancy 300 Gerandomiseerd Crossover Zwangerschap

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De klinische studie NCT07405723 is een interventioneel studie bij Zwangerschap, Blood Pressure Measurement in Pregnancy, Hypertensieve aandoening tijdens de zwangerschap met de status nog niet rekruterend. De inclusie van 300 deelnemers start op 1 maart 2026. De studie wordt geleid door Chaim Sheba Medisch Centrum en de voltooiing is gepland op 31 december 2026. Laatste update op ClinicalTrials.gov: 25 februari 2026.
Beknopte samenvatting
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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Uitgebreide beschrijving
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...Toon meer
Officiële titel

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

Aandoeningen
ZwangerschapBlood Pressure Measurement in PregnancyHypertensieve aandoening tijdens de zwangerschap
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • 2177-25-SMC
  • 2177-25-SMC (Overige identificatiecode) (Sheba Medical Center IRB)
NCT-ID
NCT07405723
Startdatum (Werkelijk)
2026-03-01
Laatste update geplaatst
2026-02-25
Verwachte einddatum
2026-12-31
Inschrijving (Geschat)
300
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
Blood Pressure Measurement
Pregnancy
Arm Position
Hypertensive Disorders of Pregnancy
Prenatal Care
Blood Pressure Accuracy
Randomized Crossover Trial
Primaire doel
Overige
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelArm 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.
ExperimenteelArm 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.
ExperimenteelArm 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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Accepteert gezonde vrijwilligers
Ja
  • 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 logoChaim Sheba Medisch Centrum
Verantwoordelijke instantie
Michal Axelrod, Hoofdonderzoeker, Obstetrician-Gynecologist, Sheba Medical Center
Centraal Contactpersoon
Contact: Michal Axelrod, MD MPH, +97235302697, [email protected]
1 Studielocaties in 1 landen
Sheba Medical Center, Ramat Gan, 5265217, Israel
Michal Axelrod, MD MPH, Contact, +97235302697, [email protected]
Michal Axelrod, MD MPH, Hoofdonderzoeker