Actively Recruiting

Phase 3
Age: 21Years - 50Years
FEMALE
NCT04011150

Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

Led by KK Women's and Children's Hospital · Updated on 2024-10-09

216

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.

CONDITIONS

Official Title

Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

Who Can Participate

Age: 21Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy primiparous women at term (36 weeks gestation or more) with American Society of Anesthesiologists (ASA) physical status 1 or 2
  • Singleton fetus pregnancy
  • In early labor with cervical dilation of 5 cm or less
  • Request labor epidural analgesia and able to receive combined spinal epidural analgesia (CSEA) as per protocol
Not Eligible

You will not qualify if you...

  • Fetus not in head-down (cephalic) position
  • Obstetric complications such as pre-eclampsia, premature rupture of membranes over 48 hours, gestational diabetes requiring insulin, or pregnancy-induced hypertension on medication
  • Uncontrolled medical conditions such as cardiac disease
  • Contraindications to neuraxial blockade or use of parenteral opioids within the last 2 hours
  • Dural puncture or suspected dural puncture at the start of combined spinal epidural analgesia (CSEA)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Actively Recruiting

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Research Team

B

Ban Leong Sng, FANZCA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour | DecenTrialz