NCT00247897

Brief Summary

The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

November 1, 2005

Last Update Submit

April 11, 2011

Conditions

Skin Bacteria

Outcome Measures

Primary Outcomes (1)

  • 25% reduction in skin bacterial colony counts at time of epidural catheter removal

Secondary Outcomes (1)

  • Skin bacterial colony count immediately following skin antisepsis. Bacterial growth on the epidural catheter tip at time of removal. Number of attempts at epidural insertion. Presence of blood in the epidural catheter at time of insertion.

Interventions

Skin antisepsisDRUG

See Detailed Description

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Request labour epidural analgesia. Able to understand English. No antibiotics taken in previous 24 hours. Membranes ruptured less than 24 hours. No current local or systemic infection. No contraindication to labour epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital Labour and Delivery Suite

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

  • Roanne Preston, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations

CA(1)