NCT02616653|Completed
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Sponsor study identifier
interventional
120
1 country
1
Study Start
January 2016
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar levels or more) when the palpation method is used in obese parturients at term in the lateral position compared to the sitting position. Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two levels higher than the level determined by ultrasonography (US) more often in the lateral than in the sitting position.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2015
Actual (reported)November 30, 2015
Actual (reported)January 2016
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)Estimation of Tuffier's line using the palpation method
Incidence of overestimation of the Tuffier's line (2 lumbar levels or more) using the palpation method in the sitting position compared to the lateral position
On Day one during medical appointment at the obstetrics clinic
Impact of fundal height on estimation of the Tuffier's line using the palpation method
On Day one during medical appointment at the obstetrics clinic
Comfort level using a verbal rating scale
On Day one during medical appointment at the obstetrics clinic
First half of participants will be assigned to have their L3-L4 intervertebral space located first in the sitting position followed by the lateral position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)
Second half of participants will be assigned to have their L3-L4 intervertebral space located first in the lateral position followed by the sitting position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)
An anesthesiologist will locate the L3-L4 space using the palpation method (Tuffier's line). An investigator trained in US imaging will proceed to the US exam of the spine specifically aiming to identify the L3-L4 intervertebral space. The investigator will note if the same level was identified and if not, which one was according to the US exam.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L4M1, Canada
Sebastien Garneau, MD
Centre hospitalier de l'Université de Montréal (CHUM)
120 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2015
First Posted
November 30, 2015
Study Start
January 2016
Actual (reported)Maternal Body Mass Index and Anovaginal Distance
Contact the study team to confirm eligibility.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
March 3, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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