A Case Series of VPIA Using Remifentanil for Labour and Delivery
VPIA
A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
1 other identifier
observational
29
1 country
1
Brief Summary
This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 7, 2017
September 1, 2015
3.7 years
April 23, 2014
February 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score
Hourly maternal pain scores
Duration of labour
Secondary Outcomes (3)
Remifentanil drug consumption
Duration of labour
Maternal side effects
Duration of labour and 1st day post delivery
Maternal outcomes
Duration of labour and one day post delivery
Other Outcomes (1)
Neonatal outcomes
Duration of labour and one day post delivery
Study Arms (1)
VPIA remifentanil
VPIA remifentanil labour analgesia
Interventions
Vital signs controlled patient assisted intravenous analgesia using remifentanil
Eligibility Criteria
Term parturients presenting to the hospital delivery suite in labour
You may qualify if:
- Patients who choose to use parenteral opioid for pain relief with informed consent
- Patients who refuse labour epidural analgesia
- Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)
You may not qualify if:
- Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
- Patients with difficulty in communication due to language differences
- Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogs
- Patients with severe respiratory disease
- Patients with history of drug dependence of recreational drug abuse
- Patients with unmanaged foetal bradycardia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's & Children's Hospital
Singapore, Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan Ling Leong, MBBS FANZCA
KK Women's & Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 24, 2014
Study Start
May 1, 2012
Primary Completion
January 1, 2016
Study Completion
June 1, 2016
Last Updated
February 7, 2017
Record last verified: 2015-09
Data Sharing
- IPD Sharing
- Will not share