- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04056403
Ultrasound Evaluation of Labor Epidural
August 12, 2019 updated by: National Taiwan University Hospital
The Use of Ultrasound to Evaluate Precision and Analgesic Efficacy of Labor Epidural Analgesia
To compare the labor epidural analgesic (EA) profiles between landmark insertion EA levels which are congruent and ingruent to ultrasound confirmation in lateral decubitus position.
Study Overview
Status
Unknown
Conditions
Detailed Description
Epidural analgesia is the mainstream method for labor analgesia.
Landmark identification of L3 to L5 spinous process is most commonly applied for determination of epidural insertion.
However, the precision of epidural catheter insertion site was affected by physiological and anatomical variations in pregnant women and positions such as sitting or lateral decubitus.
Previous study showed the clinical estimation would be ≥ 1 vertebral level higher than the anatomical position determined by ultrasound at least 40% of the time in sitting position among western pregnant women.
For asian parturients, epidural analgesia is commonly performed in lateral decubitus position because of smaller stature.
In addition, it remains uncertain whether the landmark epidural insertion level congruent or ingruent is associated with different analgesia profiles such as the dosage requirement and the frequncy of adjustment.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Parturient who receive labor epidural
Description
Inclusion:
- Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
- Using patient-controlled epidural analgesia
Exclusion:
- who has an accidental epidural puncture
- who receives epidural insertion by ultrasound identification
- who uses of magnesium sulfate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of landmark epidural level
Time Frame: 10 minute
|
Validation of landmark localization of epidural insertion level by using ultrasound examination
|
10 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Labor analgesic dose
Time Frame: one day
|
Influences of accurate epidural insertion level on labor epidural analgesic dose
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2019
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 14, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201907006RINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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