Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a smarter epidural pump reduce leg weakness during labor?

NCT ID NCT04011150

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new epidural pump method for women in labor. The method, called variable volume automated mandatory boluses, delivers pain medication in a way that may spread the drug more evenly, potentially reducing leg weakness while still controlling pain. The study includes healthy first-time mothers at term with a single baby, who request an epidural. Researchers will compare this new method to standard care, looking at how often motor block occurs and whether it affects the need for assisted delivery.

What this could mean

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

Active substance
An epidural infusion pump delivering a combination of ropivacaine (a local anesthetic) and fentanyl (an opioid) into the space around the spinal cord.
What this could lead to
If successful, this could lead to a more personalized epidural technique that reduces leg weakness during labor and lowers the chance of needing forceps or vacuum delivery.
What could go wrong
This is a single-hospital trial, and results may not apply to all settings. The new pump method might not reduce motor block or could have unforeseen effects on pain relief or delivery outcomes.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

197 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Aug 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 (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation); * Singleton fetus; * In early labor stage (cervical dilation ≤5cm); * Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol. Exclusion Criteria: * Non-cephalic fetal presentation; * 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; * Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours; * Dural puncture/ suspected dural puncture at initiation of CSEA.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breakthrough pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Breakthrough Pain Labor Pain

As listed by the trial registrant

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

Breakthrough pain Labor pain

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.