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Die klinische Studie NCT07405723 für Schwangerschaft, Blood Pressure Measurement in Pregnancy, Hypertensive Schwangerschaftserkrankung ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Arm Position and Blood Pressure Measurement Accuracy During Pregnancy 300 Randomisiert Crossover-Design Schwangerschaft

Noch nicht rekrutierend
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Die klinische Studie NCT07405723 ist eine interventionsstudie zur Untersuchung von Schwangerschaft, Blood Pressure Measurement in Pregnancy, Hypertensive Schwangerschaftserkrankung und hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2026 geplant, bis 300 Teilnehmer aufgenommen werden. Durchgeführt von Chaim-Sheba-Medizinzentrum wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. Februar 2026 aktualisiert.
Kurzbeschreibung
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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Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
SchwangerschaftBlood Pressure Measurement in PregnancyHypertensive Schwangerschaftserkrankung
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • 2177-25-SMC
  • 2177-25-SMC (Andere Kennung) (Sheba Medical Center IRB)
NCT-Nummer
NCT07405723
Studienbeginn (tatsächlich)
2026-03-01
Zuletzt aktualisiert
2026-02-25
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
300
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Blood Pressure Measurement
Pregnancy
Arm Position
Hypertensive Disorders of Pregnancy
Prenatal Care
Blood Pressure Accuracy
Randomized Crossover Trial
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellArm 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.
ExperimentellArm 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.
ExperimentellArm 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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)
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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)
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
Akzeptiert gesunde Freiwillige
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-Medizinzentrum
Verantwortliche Partei
Michal Axelrod, Hauptprüfer, Obstetrician-Gynecologist, Sheba Medical Center
Zentrale Studienkontakte
Kontakt: Michal Axelrod, MD MPH, +97235302697, [email protected]
1 Studienstandorte in 1 Ländern
Sheba Medical Center, Ramat Gan, 5265217, Israel
Michal Axelrod, MD MPH, Kontakt, +97235302697, [email protected]
Michal Axelrod, MD MPH, Hauptprüfer