Using the intergluteal cleft to find the neuraxial midline in pregnant women
Determination of the Utility of the Intergluteal Cleft as a Landmark for nEuraxial Midline identiFication in obsteTric Patients
This study tests if using the space between the buttocks can help doctors find the right spot for anesthesia in pregnant women better than using ultrasound.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05983029 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using the intergluteal cleft as a landmark for identifying the neuraxial midline in obstetric patients. It compares this method to ultrasound, which serves as the reference standard. The goal is to determine if this novel approach can improve the accuracy of neuraxial anesthesia placement in pregnant women. The study will measure the horizontal distance between the intergluteal cleft and the neuraxial midline as identified by ultrasound.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 years or older who are at least 37 weeks pregnant.
Not a fit: Patients with a history of spine surgery, scoliosis, or those unable to understand English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of neuraxial anesthesia in obstetric patients, potentially improving patient outcomes during labor.
How similar studies have performed: While this approach is novel, similar studies have not been widely reported, indicating that this could be an untested methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Guy's Hospital, Great Maze Pond — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Neel Desai, FRCA
- Email: Neel.Desai@gstt.nhs.uk
- Phone: 02071887188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.