Obesity Complicating ChildbirthNCT05052658
Ultrasound High BMI Study
A study testing Neuraxial block placement in people with Obesity Complicating Childbirth, run by University of Kentucky at 1 site in United States.
Trial summary
This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity Complicating Childbirth
- What is being tested?
- Neuraxial block placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 13 Dec 2022
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
- Subject with American Society of Anesthesiologists score equal to or less than III.
- Subject with singleton gestation equal to or greater than 37 weeks.
- Subjects with planned labor epidural in sitting position.
Who cannot join
- Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
- Patients with major back abnormalities (back surgery, significant scoliosis).
- Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
- Patients having cesarean section or combined spinal epidural.
- Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
- Patient needing a translator for procedure.
- Patients who are prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: Time for Neuraxial Block Placement With Use of Ultrasound in Patients With High BMI
This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.
Read the detailed description
Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This somewhat "blind" technique to identify the spinal space becomes more difficult and less reliable in obese patients. Ultrasound devices have become common and successful with blocks and venous access, both involving mostly soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and a long learning curve. A newly developed pocket-size ultrasound addresses these limitations by providing real-time pattern recognition for spinal bony structures and 3D overlay for recognition of midline spinous process and intervertebral space using an automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will reduce time to epidural placement and reduce number of passes in obese patients.
- Conditions
- Obesity Complicating Childbirth
- Being tested
- Neuraxial block placement
- Keywords
- High BMI, pregnancy, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraxial block placementProcedure or surgery
The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Palpation Group | Active comparator | Not described Receives: Procedure: Neuraxial block placement |
| Ultrasound Group | Experimental | Not described Receives: Procedure: Neuraxial block placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to placement of neuraxial block in parturients with BMI=35-59.9
Time period from initially touching the patient's skin to removal of Tuohy needle after catheter placement.
Measured: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Number of passes to placement of neuraxial block in parturients with BMI=35-59.9
Number of times the epidural needle is removed from skin and re-entered
Measured: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start27 Oct 2021
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Complicating ChildbirthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Fragneto, University of Kentucky
- Investigators
- Regina Fragneto, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052658
- Sponsor's protocol ID
- 69690
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2021
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time for Neuraxial Block Placement With Use of Ultrasound in Patients With High BMI
- ClinicalTrials.gov ID
- NCT05052658
- Acronym / sponsor ID
- 69690
- Conditions
- Obesity Complicating Childbirth
- Keywords
- High BMI, pregnancy, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 22 Sep 2021 (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.
This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.
Detailed description
Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This somewhat "blind" technique to identify the spinal space becomes more difficult and less reliable in obese patients. Ultrasound devices have become common and successful with blocks and venous access, both involving mostly soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and a long learning curve. A newly developed pocket-size ultrasound addresses these limitations by providing real-time pattern recognition for spinal bony structures and 3D overlay for recognition of midline spinous process and intervertebral space using an automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will reduce time to epidural placement and reduce number of passes in obese patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation Group | Active comparator | Procedure: Neuraxial block placement |
| Ultrasound Group | Experimental | Procedure: Neuraxial block placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
- Subject with American Society of Anesthesiologists score equal to or less than III.
- Subject with singleton gestation equal to or greater than 37 weeks.
- Subjects with planned labor epidural in sitting position.
Key exclusion criteria (7 listed)
- Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
- Patients with major back abnormalities (back surgery, significant scoliosis).
- Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
- Patients having cesarean section or combined spinal epidural.
- Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
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 |
|---|---|---|
| Neuraxial block placementThe time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed. | Procedure or surgery | Palpation Group, Ultrasound Group |
Primary outcome
Time to placement of neuraxial block in parturients with BMI=35-59.9
Time frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Time period from initially touching the patient's skin to removal of Tuohy needle after catheter placement.
Number of passes to placement of neuraxial block in parturients with BMI=35-59.9
Time frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Number of times the epidural needle is removed from skin and re-entered
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Regina Fragneto, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuraxial block placement in people with Obesity Complicating Childbirth, run by University of Kentucky 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 7 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 25 Jan 2023. 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?
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?
Time to placement of neuraxial block in parturients with BMI=35-59.9 (time frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour). The study lists 2 primary outcomes in all. 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 25 Jan 2023.