Predictive Hemodynamic Monitoring During Elective Cesarean Section
NCT: NCT06729827 · COMPLETED
Brief Summary
Single shot spinal anesthesia (SA) is the most commonly used technique for Caesarean section (CS) . SA is associated with maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting, bradycardia and fetal acidosis. Preventive administration of vasopressors is widely used to counterbalance hypotension. Routine prophylactic infusion of phenylephrine and norepinephrine raises concerns for unnecessary treatment, reactive hypertension, baroreceptor-mediated bradycardia, and effects on fetal acidosis. Non-invasive continuous measurement of arterial pressure using a finger cuff is well established. Hypotension Prediction Index - HPI is an algorithm that could predict the onset of hypotension in working on invasive and non-invasive arterial waveform signal. The aim of this prospective randomized study is to compare the amount of PSH during elective caesarean section among two groups of patients receiving standard intermittent hemodynamic monitoring versus continuous ClearSight-HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute. The secondary aim was to study the impact of maternal PSH during CS on foetal outcome evaluated by comparing neonatal Apgar scores at 1 and 5 minutes after birth, and umbilical cord arterial and venous pH in the two groups.
Frequently Asked Questions
What is Predictive Hemodynamic Monitoring During Elective Cesarean Section?
Predictive Hemodynamic Monitoring During Elective Cesarean Section is a clinical trial registered under NCT06729827. Current status: COMPLETED.
What is the status of NCT06729827?
The current status of NCT06729827 (Predictive Hemodynamic Monitoring During Elective Cesarean Section) is: COMPLETED.
When did Predictive Hemodynamic Monitoring During Elective Cesarean Section start?
Predictive Hemodynamic Monitoring During Elective Cesarean Section started on 2025-03-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.