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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05983029
Acronym
CLEFT
Enrollment
100
Registered
2023-08-09
Start date
2023-12-07
Completion date
2024-09-30
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Anesthesia Problems

Brief 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

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

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

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Horizontal distance between intergluteal cleft and neuraxial midline12 monthsOne horizontal distance and hence one primary outcome

Secondary

MeasureTime frameDescription
Difference in horizontal distance stratified by body mass index12 monthsVariation for BMI and recorded data
Difference in horizontal distance stratified by presence of pre-eclampsia12 monthsVariation for pre-ecalmpsia and recorded data
Difference in horizontal distance stratified by presence of pregnancy induced hypertension12 monthsVariation for pregnancy induced hypertension a and recorded data

Countries

United Kingdom

Contacts

STUDY_CHAIRGill Arbane, BSc

Guys' & St Thomas' NHS Foundation Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026