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Recruiting NCT06892665

The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

Trial Parameters

Condition Pregnancy Related
Sponsor National University of Malaysia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age 40 Years
Start Date 2025-01-01
Completion 2025-10-31
Interventions
Hypotension prediction indexNon invasive Blood Pressure Monitoring

Brief Summary

During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. However, a new medical device is now available to predict hypotension. It is called the Hypotension Prediction Index (HPI). This device allows the prediction of hypotension; hence, treatment can be given before it occurs. It has been widely utilised in major surgeries like abdominal tumour surgery and cardiac surgery worldwide and has shown a substantial reduction in hypotension. This study aims to determine whether the duration and severity of hypotension can be reduced when HPI is used in lower segment caesarean sections. The secondary objective of the study is to determine if the complication rate can be reduced in both mother and baby.

Eligibility Criteria

Inclusion criteria: * ≥ 37 weeks of gestation * Elective CS * Age between 18 - 40 years old * Singleton pregnancy * Planned for spinal anaesthesia Exclusion criteria: * American Society of Anesthesiologists (ASA) III and above * Body mass index (BMI) ≥ 40 kg/m2 * Increased risk of developing peripartum haemorrhage * History of peripartum haemorrhage * Placenta previa major, accrete, increta, percreta * Gravida ≥ 5 * Presence of large uterine fibroids * Congenital bleeding disorders such as Haemophilia A, Haemophilia B and Von Willebrand disease * Acquired bleeding disorders such as thrombocytopenia and coagulopathy * Contraindications to finger cuff orNIBP application, such as finger ischaemia, upper limb neurological deficit, discoloured nail * Cardiac arrhythmias and aortic regurgitation * Patient's refusal

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