NCT03065569

Brief Summary

A trial comparing outcomes for different epidural techniques in labour analgesia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

January 19, 2017

Last Update Submit

May 23, 2018

Conditions

Labour Analgesia

Outcome Measures

Primary Outcomes (1)

  • Bupivacaine requirement for analgesia

    milligram of bupivacaine used per hour

    From randomization until delivery

Study Arms (2)

Standard Epidural Technique

ACTIVE COMPARATOR

Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.

Drug: Bupivacaine

Combined Spinal Epidural Technique

EXPERIMENTAL

CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.

Drug: Bupivacaine

Interventions

BupivacaineDRUG

16 mL of 0.125% bupivacaine

Combined Spinal Epidural TechniqueStandard Epidural Technique

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, singleton presentation at term

You may not qualify if:

  • Significant comorbidities likely to alter outcome of labour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

British Columbia's Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anton Chau, MD MMSc

    UBC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 19, 2017

First Posted

February 28, 2017

Study Start

May 7, 2017

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)