Clincosm LogoSign in Get a demo

Real-time Ultrasound Guided Labor Epidural Placement

Sponsor
University of Pittsburgh (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00811304
Collaborator
(none)
0
Enrollment
1
Location
13
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Feb 1, 2010
    Anticipated Study Completion Date :
    Feb 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    US group

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

    Outcome Measures

    Primary Outcome Measures

    1. Failed epidural placement rate [From admission untill delivery]

    Secondary Outcome Measures

    1. The incidence of post dural puncture headache. [From insertion of epidural to 48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Magee-Womens Hospital Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh

    Investigators

    • Principal Investigator: Manuel C Vallejo, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00811304
    Other Study ID Numbers:
    • PRO08090016
    First Posted:
    Dec 18, 2008
    Last Update Posted:
    Feb 4, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by , ,
    ultrasound
    labor epidural
    failed epidural
    outcome
    Epidural insertion under realtime ultrasound guidance

    Study Results

    No Results Posted as of Feb 4, 2013