Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060419) titled 'Comparison of Positional Invariance Between Continuous Noninvasive and Oscillometric Cuff Blood Pressure Measurements in Term Pregnant Women: A Prospective Simultaneous-Measurement Study' on Jan. 21.
Study Type:
Observational
Primary Sponsor:
Institute - Kitasato University
Condition:
Condition - Pregnancy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will simultaneously measure blood pressure using continuous noninvasive blood pressure monitoring (cNIBP) and a noninvasive oscillometric cuff device in term pregnant women, and compare the Position Invariance Index (PII) between the two methods (cNIBP vs cuff) across six commonly used clinical positions: supine, left lateral, right lateral, hands-and-knees, sitting, and standing.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Patients with ASA physical status II who are scheduled to undergo elective cesarean delivery at 37 weeks gestation or later and who provide written informed consent to participate in the study.
Key exclusion criteria - Pregnant women with a history of cardiac disease, hypertension, or arrhythmia.
Pregnant women with multiple gestation, threatened preterm labor, or fetal growth restriction and/or structural anomalies.
Pregnant women with abnormal vital signs on admission.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 07 Day
Date of IRB - 2026 Year 01 Month 21 Day
Anticipated trial start date - 2026 Year 01 Month 22 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069116
Disclaimer: Curated by HT Syndication.
