Obesity, MorbidLOTUSNCT06305260
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
A study testing Lumbar Ultrasound in people with Obesity, Morbid and Labor Pain, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Labor Pain
- What is being tested?
- Lumbar Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Dec 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- English Speaking
- BMI (Body Mass Index) > 40
- Ability to provide informed consent and verbally disclose their medical history
Who cannot join
- History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
- Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
- Minors
- Adults unable to make their own decisions or with cognitive issues or developmental delays
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40
The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. The main questions it aims to answer are:
- Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
- Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.
- Conditions
- Obesity, Morbid, Labor Pain
- Being tested
- Lumbar Ultrasound
- Keywords
- Labor Epidural
- Medical subject headings
- Obesity, Morbid, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar UltrasoundDiagnostic test
Investigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Lumbar Palpation | No intervention | This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care. |
| Pre-procedural Lumbar Ultrasound | Experimental | This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement. Receives: Diagnostic Test: Lumbar Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural Redirects
Total number of epidural needle redirections
Measured: Day of Epidural
Secondary outcomes (4)
Total time to epidural space
Total time to epidural space observed via loss of resistance.
Measured: Day of Epidural
Number of attempts at a different level
Number of attempts at a different lumbar level.
Measured: Day of Epidural
Epidural replacement rate
Includes epidurals that needed to be replaced because of failed epidural or inadequate pain relief
Measured: Day of Epidural
Patient satisfaction
Patient's satisfaction with epidural experience observed by a survey in post-partum
Measured: 24 hours post-epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305260
- Sponsor's protocol ID
- STUDY00000324
- Acronym
- LOTUS
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40
- ClinicalTrials.gov ID
- NCT06305260
- Acronym / sponsor ID
- LOTUS / STUDY00000324
- Conditions
- Obesity, Morbid, Labor Pain
- Keywords
- Labor Epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. The main questions it aims to answer are:
- Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
- Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Lumbar Palpation | No intervention | –This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care. |
| Pre-procedural Lumbar Ultrasound | Experimental | Diagnostic Test: Lumbar UltrasoundThis group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- English Speaking
- BMI (Body Mass Index) > 40
- Ability to provide informed consent and verbally disclose their medical history
Key exclusion criteria (5 listed)
- History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
- Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
- Minors
- Adults unable to make their own decisions or with cognitive issues or developmental delays
- Prisoners
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 |
|---|---|---|
| Lumbar UltrasoundInvestigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement. | Diagnostic test | Pre-procedural Lumbar Ultrasound |
Primary outcome
Epidural Redirects
Time frame: Day of Epidural
Total number of epidural needle redirections
4 secondary outcomes
Total time to epidural space
Time frame: Day of Epidural
Number of attempts at a different level
Time frame: Day of Epidural
Epidural replacement rate
Time frame: Day of Epidural
Patient satisfaction
Time frame: 24 hours post-epidural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Ultrasound in people with Obesity, Morbid and Labor Pain, run by MetroHealth Medical Center at 1 site in United States.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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 States. 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?
Results are not available in the source record.
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?
Epidural Redirects (time frame: Day of Epidural). 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 20 Mar 2024.