The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

NCT06892665 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

  • Pregnancy Related
  • Hypotension
  • Maternal-Fetal Relations
  • Cesarean Section Complications

Interventions

DEVICE

Hypotension prediction index

HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon

DEVICE

Non invasive Blood Pressure Monitoring

Anaesthetist will respond to hemodynamic variables using NIBP

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Azlina Masdar · National University of Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-10-31
Completion
2026-01-31

Countries

  • Malaysia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892665 on ClinicalTrials.gov