Epidural CatheterizationNCT07056166
Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
An observational study of Epidural Catheterization, run by University of Padova at 1 site in Italy.
Trial summary
This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Catheterization
- What is being tested?
- epidural catheter and spine ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 563 participants
- Where
- 1 siteItaly
- Study dates
- 13 Aug 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult pregnant women (≥18 years old) admitted to the Labor and Delivery Unit at the University Hospital of Padua who are candidates for epidural catheter placement for labor analgesia. All participants must provide written informed consent. No specific exclusion criteria apply.
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Padua
Padua, 35127
Alessandro De Cassai, Medical Doctor, +390498213090, alessandro.decassai@aopd.veneto.it
About this study
Official title: Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.
Read the detailed description
This is a single-center, prospective observational study aimed at evaluating whether specific ultrasound measurements of spinal structures in pregnant women can predict technical difficulty in placing an epidural catheter during labor analgesia. All procedures performed are part of standard care and are routinely offered in the labor and delivery unit. Patients who consent to participate will undergo a lumbar ultrasound prior to epidural catheter placement. Data will be collected regarding anatomical and clinical characteristics, ultrasound findings, and procedural details. The study will run for two years or until the estimated sample size of 563 patients is reached. The results are intended to identify non-invasive predictors of challenging epidural placement, potentially improving patient safety and resource allocation.
- Conditions
- Epidural Catheterization
- Being tested
- epidural catheter, spine ultrasonography
- Keywords
- Epidural analgesia, Pregnancy, Spinal ultrasound, Difficult epidural, Obstetric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheterProcedure or surgery
Epidural catheter placement for labor analgesia
spine ultrasonographyProcedure or surgery
An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients undergoing epidural placement for labor analgesia | Not described Receives: Procedure: epidural catheter; Procedure: spine ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Difficulty of epidural catheter placement
Defined as the need for more than one puncture attempt (exiting the skin with the needle) or the involvement of a second operator to successfully place the epidural catheter.
Measured: Periprocedural
Secondary outcomes (12)
Number of puncture attempts
Number of attempts required to successfully insert the epidural catheter.
Measured: Periprocedural
(Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level
The distance measured in cm between the skin surface and the spinous process at the intended epidural insertion site, assessed using ultrasound scanning.
Measured: Periprocedural
(Predictor of difficult Epidural) Distance between spinous processes
Measured in centimeters by ultrasound to assess interspinous space width.
Measured: Periprocedural
(Predictor of difficult Epidural) Distance from skin to transverse process
Measured in centimeters by ultrasound to assess distance between skin and transverse process.
Measured: Periprocedural
(Predictor of difficult Epidural) Patient age
Measured in years
Measured: Baseline
(Predictor of difficult Epidural) Pre-pregnancy weight
Measured in kg
Measured: Baseline
(Predictor of difficult Epidural) Current weight
Measured in kg
Measured: Baseline
(Predictor of difficult Epidural) Body Mass Index (BMI)
Measured in kg/cm2
Measured: Baseline
(Predictor of difficult Epidural) Palpability of spinous processes
Measured as "Yes", "Not completely", "No"
Measured: Periprocedural
(Predictor of difficult Epidural) Previous spinal surgery
"Yes" or "No" variable. Accounting for any type of vertebral surgery
Measured: Baseline
(Predictor of difficult Epidural) Presence of scoliosis
"Yes" or "No" variable.
Measured: Baseline
(Predictor of difficult Epidural) Operator Experience
Operator related. Defined as the number of epidural catheter previously positioned
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start13 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural CatheterizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056166
- Sponsor's protocol ID
- AOP3720
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2025
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
- ClinicalTrials.gov ID
- NCT07056166
- Acronym / sponsor ID
- AOP3720
- Conditions
- Epidural Catheterization
- Keywords
- Epidural analgesia, Pregnancy, Spinal ultrasound, Difficult epidural, Obstetric anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 563 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jul 2025 (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 observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.
Detailed description
This is a single-center, prospective observational study aimed at evaluating whether specific ultrasound measurements of spinal structures in pregnant women can predict technical difficulty in placing an epidural catheter during labor analgesia. All procedures performed are part of standard care and are routinely offered in the labor and delivery unit. Patients who consent to participate will undergo a lumbar ultrasound prior to epidural catheter placement. Data will be collected regarding anatomical and clinical characteristics, ultrasound findings, and procedural details. The study will run for two years or until the estimated sample size of 563 patients is reached. The results are intended to identify non-invasive predictors of challenging epidural placement, potentially improving patient safety and resource allocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients undergoing epidural placement for labor analgesia | – | Procedure: epidural catheter, Procedure: spine ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult pregnant women (≥18 years old) admitted to the Labor and Delivery Unit at the University Hospital of Padua who are candidates for epidural catheter placement for labor analgesia. All participants must provide written informed consent. No specific exclusion criteria apply.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| epidural catheterEpidural catheter placement for labor analgesia | Procedure or surgery | Pregnant patients undergoing epidural placement for labor analgesia |
| spine ultrasonographyAn ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest | Procedure or surgery | Pregnant patients undergoing epidural placement for labor analgesia |
Primary outcome
Incidence of Difficulty of epidural catheter placement
Time frame: Periprocedural
Defined as the need for more than one puncture attempt (exiting the skin with the needle) or the involvement of a second operator to successfully place the epidural catheter.
12 secondary outcomes
Number of puncture attempts
Time frame: Periprocedural
(Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level
Time frame: Periprocedural
(Predictor of difficult Epidural) Distance between spinous processes
Time frame: Periprocedural
(Predictor of difficult Epidural) Distance from skin to transverse process
Time frame: Periprocedural
(Predictor of difficult Epidural) Patient age
Time frame: Baseline
(Predictor of difficult Epidural) Pre-pregnancy weight
Time frame: Baseline
(Predictor of difficult Epidural) Current weight
Time frame: Baseline
(Predictor of difficult Epidural) Body Mass Index (BMI)
Time frame: Baseline
(Predictor of difficult Epidural) Palpability of spinous processes
Time frame: Periprocedural
(Predictor of difficult Epidural) Previous spinal surgery
Time frame: Baseline
(Predictor of difficult Epidural) Presence of scoliosis
Time frame: Baseline
(Predictor of difficult Epidural) Operator Experience
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- 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.
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 Epidural Catheterization, run by University of Padova at 1 site in Italy.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro De Cassai, Medical Doctor (+390498213090, alessandro.decassai@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Difficulty of epidural catheter placement (time frame: Periprocedural). 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 18 Sep 2025.