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Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

This study is currently recruiting participants.

Verified November 2012 by Royal Victoria Hospital, Canada

Sponsor:

Information provided by (Responsible Party):

Albert Moore, Royal Victoria Hospital, Canada

ClinicalTrials.gov Identifier:

NCT00954317

First received: August 5, 2009

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2009

Last Updated Date

November 29, 2012

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of epidural medication boluses required [ Time Frame: 30 minutes and 1 hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00954317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Labour progress [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

Official Title ^ICMJE

Do Epidurals Placed at a Lower Level Improve Labour Analgesia

Brief Summary

The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Labor Analgesia

Intervention ^ICMJE

Procedure: epidural placed low
epidural placed low
Procedure: high epidural
high epidural

Study Arm (s)

Active Comparator: Low epidural
epidural placed in the lower lumbar vertebral column

Intervention: Procedure: epidural placed low
Experimental: high epidural
high epidural

Intervention: Procedure: high epidural

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: albert r moore, md

514.934.1934 ext 34880

moore_albert@hotmail.com

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00954317

Other Study ID Numbers ^ICMJE

SDR-08-052

Has Data Monitoring Committee

No

Responsible Party

Albert Moore, Royal Victoria Hospital, Canada

Study Sponsor ^ICMJE

Royal Victoria Hospital, Canada

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Royal Victoria Hospital, Canada

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP