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Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438099
First Posted: September 21, 2011
Last Update Posted: August 26, 2013
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.
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
  Purpose
This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

Resource links provided by NLM:


Further study details as provided by Paolo Severgnini, Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • The congruity between palpatory technique and ultrasound lumbar evaluation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia


Secondary Outcome Measures:
  • Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients will be measured and compared to the needle depth


Enrollment: 300
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
normal subjects
parturients admitted to the labor ward who request epidural analgesia with BMI < 30
obese subjects
parturients admitted to the labor ward who request epidural analgesia with BMI > 30

Detailed Description:

This study has four specific aims:

  1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
  2. to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
  3. to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
  4. to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor
Criteria

Inclusion Criteria:

  • all women who request epidural analgesia for labor

Exclusion Criteria:

  • all women who present contraindication for epidural analgesia
  Contacts and Locations
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): NCT01438099


Locations
Italy
Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Paolo Severgnini, Prof. Universita' degli Studi dell'Insubria, Varese, Italy
  More Information

Responsible Party: Paolo Severgnini, Prof., Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01438099     History of Changes
Other Study ID Numbers: 18894
First Submitted: September 14, 2011
First Posted: September 21, 2011
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by Paolo Severgnini, Università degli Studi dell'Insubria:
epidural analgesia
ultrasound
labor analgesia
labor