Obstetric Anesthesia ProblemsCLEFTNCT05983029
Determination of Utility of Intergluteal Cleft as Landmark for Neuraxial Midline in Obstetrics
An observational study of Obstetric Anesthesia Problems, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Anesthesia Problems
- What is being tested?
- Intergluteal Cleft, Neuraxial Midline and Horizontal Distance between Vertical Markings
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant patients
Who may be able to join
- Female
- 18 years of age or older
- Gestation of 37 weeks or above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's Hospital, Great Maze Pond
London, London, SE1 9RT
About this study
Official title: 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
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
- Conditions
- Obstetric Anesthesia Problems
- Being tested
- Intergluteal Cleft, Neuraxial Midline, Horizontal Distance between Vertical Markings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intergluteal CleftDiagnostic test
Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line
Neuraxial MidlineDiagnostic 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 MarkingsDiagnostic test
The horizontal distance between these two vertical marks will be measured at the level of the intercristal line
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Intergluteal Cleft; Diagnostic Test: Neuraxial Midline; Diagnostic Test: Horizontal Distance between Vertical Markings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal distance between intergluteal cleft and neuraxial midline
One horizontal distance and hence one primary outcome
Measured: 12 months
Secondary outcomes (3)
Difference in horizontal distance stratified by body mass index
Variation for BMI and recorded data
Measured: 12 months
Difference in horizontal distance stratified by presence of pre-eclampsia
Variation for pre-ecalmpsia and recorded data
Measured: 12 months
Difference in horizontal distance stratified by presence of pregnancy induced hypertension
Variation for pregnancy induced hypertension a and recorded data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start7 Dec 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anesthesia ProblemsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gill Arbane, BSc, Study chair, Guys' & St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983029
- Sponsor's protocol ID
- 291462
- Acronym
- CLEFT
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Utility of the Intergluteal Cleft as a Landmark for nEuraxial Midline identiFication in obsteTric Patients
- ClinicalTrials.gov ID
- NCT05983029
- Acronym / sponsor ID
- CLEFT / 291462
- Conditions
- Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Intergluteal Cleft, Diagnostic Test: Neuraxial Midline, Diagnostic Test: Horizontal Distance between Vertical MarkingsEach 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients
Key inclusion criteria (3 listed)
- Female
- 18 years of age or older
- Gestation of 37 weeks or above
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intergluteal CleftMarking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line | Diagnostic test | Study Group |
| Neuraxial MidlineMarking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line | Diagnostic test | Study Group |
| Horizontal Distance between Vertical MarkingsThe horizontal distance between these two vertical marks will be measured at the level of the intercristal line | Diagnostic test | Study Group |
Primary outcome
Horizontal distance between intergluteal cleft and neuraxial midline
Time frame: 12 months
One horizontal distance and hence one primary outcome
3 secondary outcomes
Difference in horizontal distance stratified by body mass index
Time frame: 12 months
Difference in horizontal distance stratified by presence of pre-eclampsia
Time frame: 12 months
Difference in horizontal distance stratified by presence of pregnancy induced hypertension
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Obstetric Anesthesia Problems
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gill Arbane, BSc study chair
Guys' & St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anesthesia Problems, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal distance between intergluteal cleft and neuraxial midline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.