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Идёт набор NCT06550570

Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum

Наблюдательное Childbirth Epidural; Anesthesia

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: QEVA questionnaire.
Кому может быть актуально
Состояния в реестре: Childbirth, Epidural; Anesthesia. 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
Франция
Следующий шаг
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Обзор

Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.

Подробное описание

This is a multi-centre prospective observational analytical before/after-type study.

Practice changes are planned in concerned departments, in particular regarding usual patient care. This observational study aims to quantify the impact of practice changes on patient experience using a Childbirth Assessment Questionnaire (QEVA). During the "before" period, patients will receive a conventional epidural while the others, during the "after" period, will receive an ambulatory epidural. The women involved into this study must fill the QEVA form 2 days after giving birth (at the maternity) then 4 weeks after giving birth in order to get a feedback related to postpartum feelings (phone call).

Вмешательства

  • Поведенческое QEVA questionnaire
    QEVA questionnaire administered at 2 days pospartum (in hospital) and 4 weeks postpartum (phone call). (specific for the study)

Первичные конечные точки

  • Obstetrical labor and delivery experience in birthgiving women [Срок оценки: at 2 days postpartum]
Вторичные конечные точки (7)
  • Relations with nursing staff and first moments with the child [Срок оценки: at 2 days postpartum]
  • Obstetrical labor and delivery experience in birthgiving women [Срок оценки: at 4 weeks postpartum]
  • Labor and delivery safety : time spent in the delivery room [Срок оценки: at 2 days postpartum]
  • Labor and delivery safety: need for instrumental extraction [Срок оценки: at 2 days postpartum]
  • Labor and delivery safety : emergency caesarean sections [Срок оценки: at 2 days postpartum]
  • Labor and delivery safety: ability to maintain spontaneous micturition [Срок оценки: at 2 days postpartum]
  • Safety of ambulation [Срок оценки: at 2 days postpartum]

Критерии участия

Критерии включения

  • Women older than 18 years old
  • with Physiological pregnancy (fetus cephalic position, normal fetal heart rate, spontaneous work between 37 and 41 SA)
  • Having benefited from epidural, usual or ambulatory depending on the study period
  • who speeks and understand French
  • who signed a free and informed consent form

Критерии исключения

  • Hearing or comprehension impairment
  • Twin pregnancies
  • Scarred uterus
  • Fetus in non cephalic position
  • Imminent delivery
  • Women under protective supervision (guardianship, curatorship)
  • Women bereaved of a spouse or child during pregnancy
  • Hospitalization of child in neonatology after delivery
  • Women hospitalized in critical care units after childbirth

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 2 центра
  • CHR Metz Thionville Hopital Femme Mère Enfant — Metz
  • CHR Metz-Thionville Hopital Mère Enfant — Thionville

Идентификаторы

NCT: NCT06550570 · 2024-02Obs-CHRMT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗