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
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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