Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT06892665

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

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, Malaysia, 56000

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here