University Hospital of Padua
Padua, 35127, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT07056166
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
-Inclusion Criteria: Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent
Exclusion criteria
- None
Treatment and study plan
epidural catheter
ProcedureEpidural catheter placement for labor analgesia
spine ultrasonography
ProcedureAn ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest
Primary outcomes
-
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.
Secondary outcomes
-
Number of puncture attempts
Time frame: Periprocedural
Number of attempts required to successfully insert the epidural catheter.
-
(Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level
Time frame: Periprocedural
The distance measured in cm between the skin surface and the spinous process at the intended epidural insertion site, assessed using ultrasound scanning.
-
(Predictor of difficult Epidural) Distance between spinous processes
Time frame: Periprocedural
Measured in centimeters by ultrasound to assess interspinous space width.
-
(Predictor of difficult Epidural) Distance from skin to transverse process
Time frame: Periprocedural
Measured in centimeters by ultrasound to assess distance between skin and transverse process.
-
(Predictor of difficult Epidural) Patient age
Time frame: Baseline
Measured in years
-
(Predictor of difficult Epidural) Pre-pregnancy weight
Time frame: Baseline
Measured in kg
-
(Predictor of difficult Epidural) Current weight
Time frame: Baseline
Measured in kg
-
(Predictor of difficult Epidural) Body Mass Index (BMI)
Time frame: Baseline
Measured in kg/cm2
-
(Predictor of difficult Epidural) Palpability of spinous processes
Time frame: Periprocedural
Measured as "Yes", "Not completely", "No"
-
(Predictor of difficult Epidural) Previous spinal surgery
Time frame: Baseline
"Yes" or "No" variable. Accounting for any type of vertebral surgery
-
(Predictor of difficult Epidural) Presence of scoliosis
Time frame: Baseline
"Yes" or "No" variable.
-
(Predictor of difficult Epidural) Operator Experience
Time frame: Periprocedural
Operator related. Defined as the number of epidural catheter previously positioned
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Padova
Other
Registry information
Official study title
Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 9, 2025
- Registry last updated
- Sep 18, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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