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OpenTrials
Completed

NCT Number: NCT05983029

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

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

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Key information

Conditions

Obstetric Anesthesia Problems

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Guy's Hospital, Great Maze Pond

London, SE1 9RT, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intergluteal Cleft

Diagnostic Test

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

Neuraxial Midline

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Horizontal distance between intergluteal cleft and neuraxial midline

    Time frame: 12 months

    One horizontal distance and hence one primary outcome

Secondary outcomes

  1. Difference in horizontal distance stratified by body mass index

    Time frame: 12 months

    Variation for BMI and recorded data

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

    Time frame: 12 months

    Variation for pre-ecalmpsia and recorded data

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

    Time frame: 12 months

    Variation for pregnancy induced hypertension a and recorded data

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: CLEFT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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