The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

Launched by NATIONAL UNIVERSITY OF MALAYSIA · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Hypotension Prediction Index (HPI) to see if it can help reduce low blood pressure during cesarean sections. Low blood pressure can occur after a woman receives spinal anesthesia for the surgery, which can be harmful to both the mother and the baby. The HPI device predicts when low blood pressure might happen, allowing doctors to take action before it occurs. The goal of this study is to find out if using the HPI can lower the amount and severity of low blood pressure during cesarean sections and also reduce complications for both mothers and babies.

To participate in this trial, women must be at least 18 years old, have a single baby, and be at least 37 weeks pregnant. They should be scheduled for an elective cesarean section and plan to use spinal anesthesia. However, certain conditions, like having a high body mass index or a history of bleeding issues, may prevent someone from joining the study. Participants will receive care as usual during their cesarean section, with the added benefit of the HPI device to help manage blood pressure.

Gender

FEMALE

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