Real-time Ultrasound Guided Labor Epidural Placement

This study has been withdrawn prior to enrollment.

(We are unable to find a clip used to stabilize the epidural needle on the ultrasound probe to allow adequate epidural catheter placement.)

Sponsor:

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00811304

First received: December 16, 2008

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 16, 2008

Last Updated Date

February 1, 2013

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Failed epidural placement rate [ Time Frame: From admission untill delivery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00811304 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The incidence of post dural puncture headache. [ Time Frame: From insertion of epidural to 48 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

Real-time Ultrasound Guided Labor Epidural Placement

Official Title ^ICMJE

Real-time Ultrasound Guided Labor Epidural Placement

Brief Summary

Specific Aim: The purpose of this study is to determine if labor epidural placement using real-time (concurrent) ultrasound guided placement is superior to the conventional "standard" epidural technique without the use of ultrasound at Magee-Womens Hospital.

Hypothesis: Ultrasound guided labor epidural placement in real-time will decrease the traditional epidural failure rate from 5% to 1%.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All pregnant women in labor.

Condition ^ICMJE

Epidural Anesthesia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

US group

All patients admitted to the labor and delivery suite who request an epidural for labor analgesia.

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

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All pregnant women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study.

Exclusion Criteria:

Men will not be included.

Gender

Female

Ages

14 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00811304

Other Study ID Numbers ^ICMJE

PRO08090016

Has Data Monitoring Committee

Yes

Responsible Party

Manuel C. Vallejo, MD / Associate Professor/University Faculty Member, Magee-Womens Hospital of UPMC

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Manuel C Vallejo, MD

Magee-Womens Hospital of UPMC

Information Provided By

University of Pittsburgh

Verification Date

February 2013

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

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