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Comparing Skin Disinfectants Before Labour Epidural Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247897
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : April 12, 2011
Information provided by:
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Skin Bacteria Drug: Skin antisepsis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: What is the Best Skin Preparation Solution for Labour Epidural Analgesia? A Randomized Prospective Trial Comparing ChloraprepTM, DuraprepTM, and Chlorhexidine 0.5% in 70% Alcohol.
Study Start Date : November 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Intervention Details:
  • Drug: Skin antisepsis
    See Detailed Description

Primary Outcome Measures :
  1. 25% reduction in skin bacterial colony counts at time of epidural catheter removal

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247897

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Canada, British Columbia
BC Women's Hospital Labour and Delivery Suite
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Roanne Preston, MD University of British Columbia
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Responsible Party: Dr. Roanne Preston, University of British Columbia Identifier: NCT00247897    
Other Study ID Numbers: C05-0389
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011