Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: epidural catheter, spine ultrasonography.
- Who it may be relevant to
- Registry conditions: Epidural Catheterization. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
Overview
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.
Interventions
- Procedure epidural catheter
Epidural catheter placement for labor analgesia - Procedure spine ultrasonography
An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest
Primary outcome measures
- Incidence of Difficulty of epidural catheter placement [Time frame: Periprocedural]
Secondary outcome measures (12)
- 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]
Eligibility criteria
-Inclusion Criteria: Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University Hospital of Padua — Padua
Identifiers
NCT: NCT07056166 · AOP3720