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This study has been withdrawn prior to enrollment.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:
University of Pittsburgh
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00811304
First received: December 16, 2008
Last updated: February 1, 2013
Last verified: February 2013
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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 May 19, 2013