New device predicts and prevents low blood pressure during C-Sections

NCT ID NCT06892665

Symptom relief Sponsor: National University of Malaysia Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called the Hypotension Prediction Index (HPI) to see if it can reduce low blood pressure during planned C-sections. Low blood pressure after spinal anesthesia can harm both mother and baby. The device alerts doctors before blood pressure drops, so they can treat it early. The trial involved 100 women and measured how long and how severe low blood pressure was, along with side effects like nausea and hospital stay length.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Hypotension Prediction Index (HPI) device
What this could lead to: If effective, this device could help doctors prevent dangerous drops in blood pressure during C-sections, reducing risks for both mother and baby.
What could go wrong: This is a small, completed trial with 100 participants, so results may not apply to all patients. The device is already used in other surgeries, but its benefit in C-sections is still being confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Dec 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * ≥ 37 weeks of gestation * Elective CS * Age between 18 - 40 years old * Singleton pregnancy * Planned for spinal anaesthesia Exclusion criteria: * American Society of Anesthesiologists (ASA) III and above * Body mass index (BMI) ≥ 40 kg/m2 * Increased risk of developing peripartum haemorrhage * History of peripartum haemorrhage * Placenta previa major, accrete, increta, percreta * Gravida ≥ 5 * Presence of large uterine fibroids * Congenital bleeding disorders such as Haemophilia A, Haemophilia B and Von Willebrand disease * Acquired bleeding disorders such as thrombocytopenia and coagulopathy * Contraindications to finger cuff orNIBP application, such as finger ischaemia, upper limb neurological deficit, discoloured nail * Cardiac arrhythmias and aortic regurgitation * Patient's refusal

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Conditions

The condition(s) this trial relates to.

hypotensive disorder pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean section complications Hypotension Maternal-fetal relations Pregnancy related

New device predicts and prevents low blood pressure during C-Sections

What the study statuses mean