Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.

NCT07056166 | Recruiting

• 1 other identifier: AOP3720
• Study Type: observational
• Target: 563
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Epidural Catheterization

Keywords

Epidural analgesia; Pregnancy; Spinal ultrasound; Difficult epidural; Obstetric anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Secondary Outcomes (12)

• Number of puncture attempts

  Periprocedural

• (Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level

  Periprocedural

• (Predictor of difficult Epidural) Distance between spinous processes

  Periprocedural

• (Predictor of difficult Epidural) Distance from skin to transverse process

  Periprocedural

• (Predictor of difficult Epidural) Patient age

  Baseline

Study Arms (1)

Pregnant patients undergoing epidural placement for labor analgesia

Procedure: epidural catheter; Procedure: spine ultrasonography

Interventions

epidural catheter PROCEDURE

Epidural catheter placement for labor analgesia

Pregnant patients undergoing epidural placement for labor analgesia

spine ultrasonography PROCEDURE

An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest

Pregnant patients undergoing epidural placement for labor analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padua

Padua, 35127, Italy

RECRUITING

Central Study Contacts

Alessandro De Cassai, Medical Doctor

CONTACT

+390498213090; alessandro.decassai@aopd.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 9, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

IT (1)