PregnancyNCT01523249
Three-Dimensional Ultrasound (3D US) in Parturients
An observational study of Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Lumbar 3D ultrasound scanning and palpation (Ultrasonix )
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Sep 2014
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Term pregnant women expecting neuraxial anesthesia or analgesia for cesarean delivery or labour pain control at BC Women's Hospital.
Who may be able to join
- ASA I or II
- Greater than or equal to 19 years old
- Term pregnancy (greater than or equal to 38 weeks gestation age)
- Ability to read English in order to understand the consent form
Who cannot join
- BMI greater than or equal to 40
- Scoliosis
- Previous difficult regional anesthesia/analgesia
- Previous lower back surgery
- Active labour
- Allergy to epidural tape, surgical paper tape, or felt pen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients
The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. The investigators hypothesize that the needle puncture site identified by 3D US is located within a 5 mm radius from the puncture site identified by palpation.
Read the detailed description
Traditionally, the manual palpation of lower back is used to identify the skin insertion point for the epidural needle placement in obstetric patients. Recently, two-dimensional ultrasound (2D US) scanning before the epidural needle insertion proved to improve an accurate determination of inter-vertebral levels and spine midline. 2D US is also useful in determining the depth to the epidural space and needle insertion angle. A three-dimensional ultrasound (3D US) technique is a new advancement in the ultrasound technology. 3D US allows for a real-time, visual guidance of the epidural needle insertion. This study will assess weather 3D US, compared to palpation, can accurately identify the skin needle insertion site for the epidural needle placement.
- Conditions
- Pregnancy
- Being tested
- Lumbar 3D ultrasound scanning and palpation (Ultrasonix )
- Keywords
- 3D ultrasonography, epidural, neuraxial anesthesia, neuraxial analgesia, pregnant woman, parturients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar 3D ultrasound scanning and palpation (Ultrasonix )Device
Also called Ultrasonix US machine (model Sonix Touch)
Paramedian ultrasound scanning of L2-3 and L3-4 lumbar interspaces to visualize ligamentum flavum. Palpation of the same intervertebral spaces to identify spine midline and needle insertion point.
| Study group | Role | What they receive |
|---|---|---|
| Scanned and palpated | Healthy, pregnant, term women delivering at BC Women's Hospital and expecting to have neuraxial anesthesia. Receives: Device: Lumbar 3D ultrasound scanning and palpation (Ultrasonix ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between two needle insertion points
To measure the distance between the needle puncture site identified by the 3D US transducer to the needle puncture site identified by palpation, measured on a transparency film.
Measured: 20 minutes of testing prior to delivery
Secondary outcomes (2)
Distance between needle insertion point and spine midline
To measure the perpendicular distance between the needle puncture site identified by the 3D US transducer to the midline identified by manual palpation (to the P-line), measured on a transparency film.
Measured: 20 minutes of testing prior to delivery
assess quality of 3D US images
To obtain US images of the epidural anatomy with various settings of the image-processing system to determine the optimal 3D US parameters that give the clearest images. An experienced sonographer will analyze the US images in the UBC laboratory using a qualitative measure of clarity (scale of 1 to 5) of the depiction of the ligamentum flavum and laminae. This quality measure will be correlated to the image acquisition parameters to determine the optimal set of parameters.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Allaudin Kamani, MD, Principal investigator, University of British Columbia and BC Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523249
- Sponsor's protocol ID
- H10-01974
- Status last verified
- Sep 2014
- First submitted
- 27 Jan 2012
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients
- ClinicalTrials.gov ID
- NCT01523249
- Acronym / sponsor ID
- H10-01974
- Conditions
- Pregnancy
- Keywords
- 3D ultrasonography, epidural, neuraxial anesthesia, neuraxial analgesia, pregnant woman, parturients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- 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.
The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. The investigators hypothesize that the needle puncture site identified by 3D US is located within a 5 mm radius from the puncture site identified by palpation.
Detailed description
Traditionally, the manual palpation of lower back is used to identify the skin insertion point for the epidural needle placement in obstetric patients. Recently, two-dimensional ultrasound (2D US) scanning before the epidural needle insertion proved to improve an accurate determination of inter-vertebral levels and spine midline. 2D US is also useful in determining the depth to the epidural space and needle insertion angle. A three-dimensional ultrasound (3D US) technique is a new advancement in the ultrasound technology. 3D US allows for a real-time, visual guidance of the epidural needle insertion. This study will assess weather 3D US, compared to palpation, can accurately identify the skin needle insertion site for the epidural needle placement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scanned and palpated | – | Device: Lumbar 3D ultrasound scanning and palpation (Ultrasonix )Healthy, pregnant, term women delivering at BC Women's Hospital and expecting to have neuraxial anesthesia. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Term pregnant women expecting neuraxial anesthesia or analgesia for cesarean delivery or labour pain control at BC Women's Hospital.
Key inclusion criteria (4 listed)
- ASA I or II
- Greater than or equal to 19 years old
- Term pregnancy (greater than or equal to 38 weeks gestation age)
- Ability to read English in order to understand the consent form
Key exclusion criteria (6 listed)
- BMI greater than or equal to 40
- Scoliosis
- Previous difficult regional anesthesia/analgesia
- Previous lower back surgery
- Active labour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar 3D ultrasound scanning and palpation (Ultrasonix )Also: Ultrasonix US machine (model Sonix Touch)Paramedian ultrasound scanning of L2-3 and L3-4 lumbar interspaces to visualize ligamentum flavum. Palpation of the same intervertebral spaces to identify spine midline and needle insertion point. | Device | Scanned and palpated |
Primary outcome
Distance between two needle insertion points
Time frame: 20 minutes of testing prior to delivery
To measure the distance between the needle puncture site identified by the 3D US transducer to the needle puncture site identified by palpation, measured on a transparency film.
2 secondary outcomes
Distance between needle insertion point and spine midline
Time frame: 20 minutes of testing prior to delivery
assess quality of 3D US images
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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.
Allaudin Kamani, MD principal investigator
University of British Columbia and BC Women's 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 Pregnancy, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Sep 2014. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between two needle insertion points (time frame: 20 minutes of testing prior to delivery). 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 30 Sep 2014.