- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00954317
Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
November 29, 2012 updated by: Albert Moore, Royal Victoria Hospital, Canada
Do Epidurals Placed at a Lower Level Improve Labour Analgesia
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- Recruiting
- Royal Victoria Hospital
-
Principal Investigator:
- albert r moore, md
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women in active labor
Exclusion Criteria:
- known contraindications to epidural analgesia
- moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
- known abnormalities of the spinal column
- any neurologic illness
- multiple gestations, fetal abnormalities or fetal presentation other than vertex
- recent history of analgesic usage
- an inability to communicate in English or French
- Body Mass Index greater than 40
- patients in pain requesting an immediate epidural
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low epidural
epidural placed in the lower lumbar vertebral column
|
epidural placed low
|
Experimental: high epidural
|
high epidural
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of epidural medication boluses required
Time Frame: 30 minutes and 1 hour
|
30 minutes and 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Labour progress
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
August 5, 2009
First Submitted That Met QC Criteria
August 6, 2009
First Posted (Estimate)
August 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 30, 2012
Last Update Submitted That Met QC Criteria
November 29, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR-08-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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