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Arm Position and Blood Pressure Measurement Accuracy During Pregnancy 300 Randomisé Essai croisé Grossesse

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L'essai clinique NCT07405723 est une étude interventionnel pour Grossesse, Blood Pressure Measurement in Pregnancy, Trouble hypertensif de la grossesse. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2026, avec un objectif de 300 participants. Dirigée par le Centre médical Chaim-Sheba, l'étude devrait être terminée d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 février 2026.
Résumé succinct
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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Description détaillée
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...Afficher plus
Titre officiel

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

Pathologies
GrossesseBlood Pressure Measurement in PregnancyTrouble hypertensif de la grossesse
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • 2177-25-SMC
  • 2177-25-SMC (Autre Identifiant) (Sheba Medical Center IRB)
Numéro NCT
NCT07405723
Date de début (réel)
2026-03-01
Dernière mise à jour publiée
2026-02-25
Date de fin (estimée)
2026-12-31
Inscription (estimée)
300
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Blood Pressure Measurement
Pregnancy
Arm Position
Hypertensive Disorders of Pregnancy
Prenatal Care
Blood Pressure Accuracy
Randomized Crossover Trial
Objectif principal
Autre
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalArm 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.
ExpérimentalArm 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.
ExpérimentalArm 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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
  • 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 logoCentre médical Chaim-Sheba
Partie responsable de l'étude
Michal Axelrod, Investigateur principal, Obstetrician-Gynecologist, Sheba Medical Center
Contact central de l'étude
Contact: Michal Axelrod, MD MPH, +97235302697, [email protected]
1 Centres de l'étude dans 1 pays
Sheba Medical Center, Ramat Gan, 5265217, Israel
Michal Axelrod, MD MPH, Contact, +97235302697, [email protected]
Michal Axelrod, MD MPH, Investigateur principal