Actively Recruiting

Phase 3
Age: 21Years - 50Years
FEMALE
ID04011150

Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery

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

216

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new method of delivering epidural analgesia during labour to improve pain relief and reduce motor block, which can lead to fewer instrumental deliveries. The study focuses on term, healthy first-time mothers with singleton pregnancies in early labour. The trial compares a novel variable volume automated mandatory bolus (VVAMB) regimen against a variable-frequency automated mandatory bolus (VAMB) to better individualize pain management. Participants receive epidural analgesia using an infusion pump delivering a combination of ropivacaine and fentanyl. One group receives the VVAMB program, which uses higher doses at lower frequency, allowing patients to control additional pain relief via a button. The other group uses the VAMB program with lower doses at higher frequency and similar patient control. The study includes a randomized, double-blind design comparing these two regimens. During labour, researchers will monitor pain relief effectiveness, incidence of motor block, and need for instrumental delivery. They will also assess breakthrough pain episodes and newborn health using the APGAR score right after delivery. The study involves close monitoring of participants during labour, with data collected on pain control and motor function. Participation spans the labour period, with outcomes assessed primarily on the day of delivery.

CONDITIONS

Brief 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 first-time pregnant women (American Society of Anesthesiologists physical status 1 or 2) at term pregnancy (36 weeks or more)
  • Singleton fetus
  • In early labour with cervical dilation of 5 cm or less
  • Requesting labour epidural analgesia and able to receive combined spinal epidural analgesia per protocol
  • Female aged between 21 and 50 years
Not Eligible

You will not qualify if you...

  • Baby not in head-down position (non-cephalic fetal presentation)
  • 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 like cardiac disease
  • Contraindications to neuraxial blockade or recent parenteral opioid use within 2 hours
  • Dural puncture or suspected dural puncture at start of combined spinal epidural analgesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During labour (up to 1 day)

Participants receive labour epidural analgesia using either the variable volume automated mandatory bolus (VVAMB) or the automated mandatory bolus (VAMB) epidural infusion pump system with ropivacaine and fentanyl during labour.

1 labour epidural analgesia session

Follow-up

Duration - 1 day after delivery

Participants are assessed after delivery for outcomes including motor block incidence, instrumental delivery, breakthrough pain, and APGAR scores.

1 post-delivery visit

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

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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