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Can a smart pump prevent dangerous drops in blood pressure during C-Sections?

NCT ID NCT03620942

Disease control Sponsor: KK Women's and Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests an automated system called ADIVA that delivers two medications to control blood pressure during spinal anesthesia for cesarean delivery. Low blood pressure is a common side effect of spinal anesthesia and can cause problems for both mother and baby. The system aims to respond faster than current methods by using a smart algorithm to keep blood pressure stable. The study includes healthy pregnant women having an elective cesarean with spinal anesthesia, and it tracks how often low or high blood pressure and nausea occur.

What this could mean

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

Active substance
An automated system (ADIVA) that delivers phenylephrine and ephedrine to control blood pressure during spinal anesthesia for cesarean section.
What this could lead to
If it works, this could lead to a safer, more automated way to manage blood pressure during cesarean deliveries, reducing risks from low blood pressure.
What could go wrong
This is an early-stage trial, and the system may not perform better than standard care. There are also risks of high blood pressure or nausea, which the trial monitors.

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

173 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

21 to 50 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: * Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients; * With singleton full-term pregnancy; * The indication for an elective cesarean delivery; * The use of spinal anaesthesia for cesarean delivery; * Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm. Exclusion Criteria: * Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications; * Contraindication to spinal anaesthesia and/or allergy to opioids.

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Conditions

The condition(s) this trial relates to.

hypotensive disorder

As listed by the trial registrant

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

Anesthesia Hypotension

Contacts and locations

Locations

  • KK Women's and Children's Hospital

    Singapore, 229899, Singapore

More trials for these conditions

Other studies related to the condition(s) this trial covers.