Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062611) titled 'Maternal Arterial Pressure and Symptoms during Cesarean Delivery under Neuraxial Anesthesia: A Multicenter Prospective Observational Study to Define Clinically Relevant Hypotension (MAPS Study)' on Aug. 19.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Metropolitan University Graguate School of Medicine
Condition:
Condition - cesarean delivery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the continuous association between the lowest mean arterial pressure (MAP) from the initiation of neuraxial anesthesia to delivery and intraoperative nausea and vomiting in women undergoing cesarean delivery, using restricted cubic spline analysis. We further aim to identify a clinically meaningful MAP threshold associated with maternal symptoms and thereby establish a clinically relevant definition of maternal hypotension during cesarean delivery.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
_ 36 weeks
2. Singleton or twin pregnancy
Key exclusion criteria - 1. Conversion to general anesthesia
2. Intrapartum emergency cesarean delivery
Target Size - 707
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 10 Day
Date of IRB - 2026 Year 08 Month 18 Day
Anticipated trial start date - 2026 Year 08 Month 19 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071615
Disclaimer: Curated by HT Syndication.
