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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This study has been withdrawn prior to enrollment.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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014