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NCT05983029 Clinical Trial

Determination of Utility of Intergluteal Cleft as Landmark for Neuraxial Midline in Obstetrics

Obstetric Anesthesia Problems Clinical Trial

— CLEFT  

Official title:
Determination of the Utility of the Intergluteal Cleft as a Landmark for nEuraxial Midline identiFication in obsteTric Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05983029
Other study ID # 291462
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 7, 2023
Est. completion date September 1, 2024

Study information
Verified date February 2024
Source Guy's and St Thomas' NHS Foundation Trust
Contact Neel Desai, FRCA
Phone 02071887188
Email Neel.Desai@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our aim is to investigate whether a novel landmark, the groove between the buttocks or the intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric patients when compared to ultrasound as the reference standard for the determination of this midline

Description:

Determine if the intergluteal cleft, when compared to ultrasound as the reference standard, can be used to identify the neuraxial midline in obstetric patients Difference in horizontal distance between the vertical lines of the intergluteal cleft and the neuraxial midline, the latter measured with ultrasound

Recruitment information / eligibility
Status Recruiting
Enrollment 99
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria - Female - 18 years of age or older - Gestation of 37 weeks or above Exclusion criteria - Acute or chronic confusional state - Allergy to ultrasound gel - Positive for COVID-19 and/or presence of symptoms consistent with SARS-Cov-2, such as anosmia, cough or fever - History of previous surgery to the spine - Scoliosis - Unable to speak and/or understand English

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intergluteal Cleft
Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line
• Neuraxial Midline
Marking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line
• Horizontal Distance between Vertical Markings
The horizontal distance between these two vertical marks will be measured at the level of the intercristal line

Locations
Country Name City State
United Kingdom Guy's Hospital, Great Maze Pond London

Sponsors (1)
Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Horizontal distance between intergluteal cleft and neuraxial midline One horizontal distance and hence one primary outcome 12 months
Secondary Difference in horizontal distance stratified by body mass index Variation for BMI and recorded data 12 months
Secondary Difference in horizontal distance stratified by presence of pre-eclampsia Variation for pre-ecalmpsia and recorded data 12 months
Secondary Difference in horizontal distance stratified by presence of pregnancy induced hypertension Variation for pregnancy induced hypertension a and recorded data 12 months
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