Actively Recruiting
The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
Led by National University of Malaysia · Updated on 2025-05-23
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 37 weeks of pregnancy
- Elective cesarean section planned
- Female aged between 18 and 40 years old
- Single baby pregnancy
- Planned spinal anesthesia for cesarean section
You will not qualify if you...
- American Society of Anesthesiologists (ASA) physical status III or higher
- Body mass index (BMI) of 40 kg/m2 or greater
- Increased risk or history of peripartum hemorrhage
- Placenta previa major, accrete, increta, or percreta
- More than 5 pregnancies (Gravida ≥ 5)
- Presence of large uterine fibroids
- Congenital bleeding disorders such as Hemophilia A, Hemophilia B, or Von Willebrand disease
- Acquired bleeding disorders like thrombocytopenia or coagulopathy
- Contraindications to finger cuff or non-invasive blood pressure application (e.g., finger ischemia, upper limb neurological deficit, or discolored nail)
- Cardiac arrhythmias or aortic regurgitation
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
Research Team
S
Syarifah Noor Nazihah Sayed Masri
CONTACT
N
Nadhirah Abdul Halim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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