NCT00811304

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%.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

December 16, 2008

Last Update Submit

February 1, 2013

Conditions

Epidural Anesthesia

Keywords

ultrasoundlabor epiduralfailed epiduraloutcomeEpidural insertion under realtime ultrasound guidance

Outcome Measures

Primary Outcomes (1)

  • Failed epidural placement rate

    From admission untill delivery

Secondary Outcomes (1)

  • The incidence of post dural puncture headache.

    From insertion of epidural to 48 hours

Study Arms (1)

US group

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

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pregnant women in labor.

You may qualify if:

  • 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.

You may not qualify if:

  • Men will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Manuel C Vallejo, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 18, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 4, 2013

Record last verified: 2013-02

Locations

US(1)