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

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

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

Study Overview

• Status: Recruiting
• Conditions: Obstetric Anesthesia Problems
• Intervention / Treatment: Diagnostic test: Intergluteal Cleft; Diagnostic test: Neuraxial Midline; Diagnostic test: Horizontal Distance between Vertical Markings

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 99

Contacts and Locations

• Study Contact: Name: Neel Desai, FRCA; Phone Number: 02071887188; Email: Neel.Desai@gstt.nhs.uk
• Study Contact Backup: Name: Marwa Salman, FRCA; Phone Number: 02071887188; Email: Marwa.Salman@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guy's Hospital, Great Maze Pond
    • Contact: Gill Arbane; Phone Number: 0207 188 8070; Email: gill.arbane@gstt.nhs.uk
    • Principal Investigator: Marwa Salman, FRCA
    • Principal Investigator: Neel Desai, FRCA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Group; Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal distance between intergluteal cleft and neuraxial midline	One horizontal distance and hence one primary outcome	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in horizontal distance stratified by body mass index	Variation for BMI and recorded data	12 months
Difference in horizontal distance stratified by presence of pre-eclampsia	Variation for pre-ecalmpsia and recorded data	12 months
Difference in horizontal distance stratified by presence of pregnancy induced hypertension	Variation for pregnancy induced hypertension a and recorded data	12 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Study Chair: Gill Arbane, BSc, Guys' & St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 291462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No