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Идёт набор NCT07056166

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

Наблюдательное Epidural Catheterization

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: epidural catheter, spine ultrasonography.
Кому может быть актуально
Состояния в реестре: Epidural Catheterization. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура epidural catheter
    Epidural catheter placement for labor analgesia
  • Процедура spine ultrasonography
    An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest

Первичные конечные точки

  • Incidence of Difficulty of epidural catheter placement [Срок оценки: Periprocedural]
Вторичные конечные точки (12)
  • Number of puncture attempts [Срок оценки: Periprocedural]
  • (Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level [Срок оценки: Periprocedural]
  • (Predictor of difficult Epidural) Distance between spinous processes [Срок оценки: Periprocedural]
  • (Predictor of difficult Epidural) Distance from skin to transverse process [Срок оценки: Periprocedural]
  • (Predictor of difficult Epidural) Patient age [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Pre-pregnancy weight [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Current weight [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Body Mass Index (BMI) [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Palpability of spinous processes [Срок оценки: Periprocedural]
  • (Predictor of difficult Epidural) Previous spinal surgery [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Presence of scoliosis [Срок оценки: Baseline]
  • (Predictor of difficult Epidural) Operator Experience [Срок оценки: Periprocedural]

Критерии участия

-Inclusion Criteria: Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University Hospital of Padua — Padua

Идентификаторы

NCT: NCT07056166 · AOP3720

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗