Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID06892665

The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial

Led by National University of Malaysia · Updated on 2025-05-23

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the Hypotension Prediction Index (HPI) device to reduce the duration and severity of low blood pressure (hypotension) during lower segment caesarean sections performed under spinal anaesthesia. This study focuses on whether predicting hypotension before it occurs can improve outcomes for both mother and baby, compared to standard blood pressure monitoring. The trial is a randomized controlled study conducted by the National University of Malaysia. The study compares two groups: one using the HPI device with the Acumen IQ cuff, allowing the anaesthetist to view and respond to haemodynamic parameters, and a second group where the anaesthetist is blinded to HPI data and uses standard non-invasive blood pressure monitoring. The HPI device is non-invasive and predicts hypotension earlier than traditional methods, potentially enabling proactive treatment. The study assesses outcomes during the caesarean section surgery. Participants will be monitored from the time spinal anaesthesia is administered until the surgery is completed. Researchers will measure the time-weighted average of mean arterial pressure below 65 mmHg as the primary outcome. Secondary measures include maternal outcomes like nausea, vomiting, blood loss, hospital stay length, satisfaction, and surgical site infection, as well as neonatal outcomes like Apgar scores, umbilical cord pH, and neonatal hospital stay. The study includes assessments up to two weeks after surgery to gather comprehensive safety and effectiveness data.

CONDITIONS

Brief Title

The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 37 weeks of gestation
  • Elective caesarean section planned
  • Age between 18 and 40 years old
  • Singleton pregnancy
  • Planned spinal anaesthesia
Not Eligible

You will not qualify if you...

  • American Society of Anesthesiologists (ASA) class III or higher
  • Body mass index (BMI) of 40 kg/m2 or more
  • Increased risk of peripartum haemorrhage
  • History of peripartum haemorrhage
  • Placenta previa major, accrete, increta, or percreta
  • Pregnancies with gravida 5 or more
  • Presence of large uterine fibroids
  • Congenital bleeding disorders such as Haemophilia A, Haemophilia 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 ischaemia, upper limb neurological deficit, discoloured nail)
  • Cardiac arrhythmias or aortic regurgitation
  • Patient refusal

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From spinal anaesthesia to completion of surgery

Participants undergo caesarean section under spinal anaesthesia with either the Hypotension Prediction Index device or standard non-invasive blood pressure monitoring to manage intraoperative hypotension.

1 surgical procedure visit (in-person)

Follow-up

Duration - Up to 2 weeks after surgery

Participants are monitored for maternal and neonatal outcomes including nausea, vomiting, surgical site infection, and hospital stay duration after surgery.

Approximately 2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

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Research Team

S

Syarifah Noor Nazihah Sayed Masri

N

Nadhirah Abdul Halim

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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Published Research Related To This Trial

Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial.

Paolo Murabito, Marinella Astuto, Filippo Sanfilippo...

https://pubmed.ncbi.nlm.nih.gov/35054083

Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia.

Luciano Frassanito, Chiara Sonnino, Alessandra Piersanti...

https://pubmed.ncbi.nlm.nih.gov/34591796

The Impact of Intraoperative Haemodynamic Monitoring, Prediction of Hypotension and Goal-Directed Therapy on the Outcomes of Patients Treated with Posterior Fusion Due to Adolescent Idiopathic Scoliosis.

Agata Andrzejewska, Jakub Miegoń, Sławomir Zacha...

https://pubmed.ncbi.nlm.nih.gov/37510686