PregnancyNCT04277988
Effect of Crossed Legged Position on Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients.
An observational study of Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
To investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients at term in the Labour and Delivery Suite, as well as those booked for elective cesarean sections who meet the inclusion criteria.
Who may be able to join
- Term gestation Singleton pregnancy 18 years or older Patients having elective cesarean delivery or induction of labor or in early labor
Who cannot join
- Allergy to ultrasound jelly
- Spinal Deformities/Previous spinal surgery
- No contraindication to neuraxial placement
- Any fetal concerns
- Morbid obesity
- Language barrier
About this study
Official title: A Comparison of the Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients in the Standard Sitting and Crossed Leg Positions: an Observational Study
To investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to the standard sitting flexed position.
Read the detailed description
This is a prospective observational study involving a total of 30 healthy term gestation pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed leg or in standard position first. Using ultrasonography, the acoustic window for lumbar spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg positions. Ultrasonography will be performed sequentially to measure the best visualized length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the paramedian view.The scanned image will be saved to be remeasured by a third observer. Patients will be asked to score their comfort level while sitting in both positions.
- Conditions
- Pregnancy
- Being tested
- Ultrasonography
- Keywords
- Maternal Analgesia, Ultrasonography Lumbar Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Length of Posterior Longitudianl Ligament, Ligamentum Flavum and Interlaminar distance visible in paramedian longitudinal view during lumbar spine ultrasonography in cross legged position will be compared to standard sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Crossed leg position | Patients in this group will be randomly allocated to sit in crossed leg position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements. Receives: Device: Ultrasonography | |
| Standard Sitting position | Patients in this group will be randomly allocated to sit in standard position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements. Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLL length
Length of the Paravertebral Longitudinal Ligament, as measured by the intrinsic ultrasound caliber tool in mm.
Measured: Up to Five minutes
Secondary outcomes (3)
LF length
Length of the Ligamentum Flavum as measured by the intrinsic ultrasound caliber tool in mm.
Measured: Up to Five minutes
ILD length
Length of the interlaminar distance, as measured by the intrinsic ultrasound caliber tool in mm.
Measured: Up to Five minutes
Patient Comfort
Patient comfort level measured on a 1-5 Likert Scale
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startMar 2016
- Primary completionAug 2016
- Study completionDec 2016
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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indu Singh, FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277988
- Sponsor's protocol ID
- 107570
- Status last verified
- Dec 2015
- First submitted
- 24 Aug 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients in the Standard Sitting and Crossed Leg Positions: an Observational Study
- ClinicalTrials.gov ID
- NCT04277988
- Acronym / sponsor ID
- 107570
- Conditions
- Pregnancy
- Keywords
- Maternal Analgesia, Ultrasonography Lumbar Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Feb 2020 (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 investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to the standard sitting flexed position.
Detailed description
This is a prospective observational study involving a total of 30 healthy term gestation pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed leg or in standard position first. Using ultrasonography, the acoustic window for lumbar spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg positions. Ultrasonography will be performed sequentially to measure the best visualized length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the paramedian view.The scanned image will be saved to be remeasured by a third observer. Patients will be asked to score their comfort level while sitting in both positions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossed leg position | – | Device: UltrasonographyPatients in this group will be randomly allocated to sit in crossed leg position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements. |
| Standard Sitting position | – | Device: UltrasonographyPatients in this group will be randomly allocated to sit in standard position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients at term in the Labour and Delivery Suite, as well as those booked for elective cesarean sections who meet the inclusion criteria.
Key inclusion criteria (1 listed)
- Term gestation Singleton pregnancy 18 years or older Patients having elective cesarean delivery or induction of labor or in early labor
Key exclusion criteria (6 listed)
- Allergy to ultrasound jelly
- Spinal Deformities/Previous spinal surgery
- No contraindication to neuraxial placement
- Any fetal concerns
- Morbid obesity
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 |
|---|---|---|
| UltrasonographyLength of Posterior Longitudianl Ligament, Ligamentum Flavum and Interlaminar distance visible in paramedian longitudinal view during lumbar spine ultrasonography in cross legged position will be compared to standard sitting position. | Device | Crossed leg position, Standard Sitting position |
Primary outcome
PLL length
Time frame: Up to Five minutes
Length of the Paravertebral Longitudinal Ligament, as measured by the intrinsic ultrasound caliber tool in mm.
3 secondary outcomes
LF length
Time frame: Up to Five minutes
ILD length
Time frame: Up to Five minutes
Patient Comfort
Time frame: Up to 5 minutes
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 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Indu Singh, FRCPC principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 1 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
PLL length (time frame: Up to Five minutes). 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 20 Feb 2020.