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This study has been withdrawn prior to enrollment.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
  Purpose

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%.


Condition
Epidural Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time Ultrasound Guided Labor Epidural Placement

Further study details as provided by University of Pittsburgh:

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

Secondary Outcome Measures:
  • The incidence of post dural puncture headache. [ Time Frame: From insertion of epidural to 48 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
US group
All patients admitted to the labor and delivery suite who request an epidural for labor analgesia.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All pregnant women in labor.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811304

Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Manuel C Vallejo, MD Magee-Womens Hospital of UPMC
  More Information

No publications provided

Responsible Party: Manuel C. Vallejo, MD / Associate Professor/University Faculty Member, Magee-Womens Hospital of UPMC
ClinicalTrials.gov Identifier: NCT00811304     History of Changes
Other Study ID Numbers: PRO08090016
Study First Received: December 16, 2008
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ultrasound
labor epidural
failed epidural
outcome
Epidural insertion under realtime ultrasound guidance

ClinicalTrials.gov processed this record on April 22, 2014