ParturientNCT04056403
Ultrasound Evaluation of Labor Epidural
An observational study of Parturient, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Parturient
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2019to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturient who receive labor epidural
Who may be able to join
- Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
- Using patient-controlled epidural analgesia
Who cannot join
- who has an accidental epidural puncture
- who receives epidural insertion by ultrasound identification
- who uses of magnesium sulfate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wu Chun-Yu, 0972653376, longersolo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parturient
- Keywords
- labor epidural, ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of landmark epidural level
Validation of landmark localization of epidural insertion level by using ultrasound examination
Measured: 10 minute
Secondary outcomes (1)
Labor analgesic dose
Influences of accurate epidural insertion level on labor epidural analgesic dose
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturientStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056403
- Sponsor's protocol ID
- 201907006RINC
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound to Evaluate Precision and Analgesic Efficacy of Labor Epidural Analgesia
- ClinicalTrials.gov ID
- NCT04056403
- Acronym / sponsor ID
- 201907006RINC
- Conditions
- Parturient
- Keywords
- labor epidural, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturient who receive labor epidural
Key inclusion criteria (2 listed)
- Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
- Using patient-controlled epidural analgesia
Key exclusion criteria (3 listed)
- who has an accidental epidural puncture
- who receives epidural insertion by ultrasound identification
- who uses of magnesium sulfate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of landmark epidural level
Time frame: 10 minute
Validation of landmark localization of epidural insertion level by using ultrasound examination
1 secondary outcome
Labor analgesic dose
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturient, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Wu (0972653376, longersolo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of landmark epidural level (time frame: 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.