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Real-time Ultrasound Guided Labor Epidural Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00811304
Recruitment Status : Withdrawn (We are unable to find a clip used to stabilize the epidural needle on the ultrasound probe to allow adequate epidural catheter placement.)
First Posted : December 18, 2008
Last Update Posted : February 4, 2013
Sponsor:
Information provided by:
University of Pittsburgh

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%.


Condition or disease
Epidural Anesthesia

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time Ultrasound Guided Labor Epidural Placement
Study Start Date : January 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Group/Cohort
US group
All patients admitted to the labor and delivery suite who request an epidural for labor analgesia.



Primary Outcome Measures :
  1. Failed epidural placement rate [ Time Frame: From admission untill delivery ]

Secondary Outcome Measures :
  1. The incidence of post dural puncture headache. [ Time Frame: From insertion of epidural to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

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