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CompletedNCT05983029CLEFTUpdated Jun 9, 2026

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

An observational study in Obstetric Anesthesia Problems, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Obstetric Anesthesia Problems
03

In context

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant patients

Inclusion criteria

  • Female
  • 18 years of age or older
  • Gestation of 37 weeks or above

Exclusion criteria

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Neuraxial Midline · Diagnostic Test: Horizontal Distance between Vertical Markings

Interventions

  • Diagnostic testIntergluteal Cleft

    Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line

  • Diagnostic testNeuraxial Midline

    Marking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line

  • Diagnostic testHorizontal Distance between Vertical Markings

    The horizontal distance between these two vertical marks will be measured at the level of the intercristal line

06

What researchers measure

Primary outcomes

  1. Horizontal distance between intergluteal cleft and neuraxial midline

    One horizontal distance and hence one primary outcome

    Time frame: 12 months

Secondary outcomes

  1. Difference in horizontal distance stratified by body mass index

    Variation for BMI and recorded data

    Time frame: 12 months

  2. Difference in horizontal distance stratified by presence of pre-eclampsia

    Variation for pre-ecalmpsia and recorded data

    Time frame: 12 months

  3. Difference in horizontal distance stratified by presence of pregnancy induced hypertension

    Variation for pregnancy induced hypertension a and recorded data

    Time frame: 12 months

07

Study locations

1 site
  • Guy's Hospital, Great Maze Pond
    London, London SE1 9RT, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05983029
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Dec 7, 2023
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024
Last update
Jun 9, 2026

Study contacts

Gill Arbane, BSc
study chair · Guys' & St Thomas' NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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