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Идёт набор NCT07663500

Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia

Без фазы С лечением Labor, Obstetric Epidural Analgesia, Obstetric Labor Duration

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: Integrated Care with Immediate Pushing, Integrated Care with Spontaneous Pushing Group, Standard Routine Care.
Кому может быть актуально
Состояния в реестре: Labor, Obstetric, Epidural Analgesia, Obstetric, Labor Duration. 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
Тайвань
Следующий шаг
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Официальное название

Integrated Intrapartum Supportive Care Combined With Different Pushing Strategies Among Women Receiving Low-Dose Epidural Analgesia: A Three-Arm Non-Randomized Quasi-Experimental Study

Обзор

This prospective, three-arm, non-randomized quasi-experimental study aims to evaluate integrated intrapartum supportive care combined with different pushing strategies among women at 37-42 weeks of gestation who receive low-dose epidural analgesia. Participants receive integrated intrapartum supportive care combined with spontaneous pushing, integrated intrapartum supportive care combined with immediate pushing, or routine intrapartum care combined with immediate pushing. The primary outcomes are the durations of the first and second stages of labor. Secondary outcomes include mode of birth, obstetric interventions, maternal outcomes, and neonatal outcomes.

Подробное описание

Participants are enrolled into one of three predefined care groups: (1) integrated intrapartum supportive care combined with spontaneous pushing (IC-SP), (2) integrated intrapartum supportive care combined with immediate pushing (IC-IP), or (3) routine intrapartum care combined with immediate pushing (RC-IP). Group allocation is determined prospectively according to the attending physician's established clinical practice. The RC-IP group receives the hospital's usual intrapartum care. Allocation is determined before implementation of the intervention and is not based on labor outcomes.

Вмешательства

  • Поведенческое Integrated Care with Immediate Pushing
    Integrated Care with Immediate Pushing Group: Participants receive an integrated intrapartum care package that includes continuous labor support and active birth positioning. Once full cervical dilation is achieved, participants are instructed to begin pushing immediately, regardless of the presence or absence of an urge to push. This directive approach to second-stage labor is guided by midwives or obstetric staff.
  • Поведенческое Integrated Care with Spontaneous Pushing Group
    Participants receive the integrated intrapartum supportive care program during the first stage of labor. During the second stage, participants are encouraged to begin pushing in response to their spontaneous urge to push rather than routinely initiating pushing immediately after full cervical dilation. The pushing strategy is implemented by the attending clinical care team according to the predefined group protocol.
  • Поведенческое Standard Routine Care
    Participants receive routine intrapartum care according to institutional clinical practice. Supportive measures and position changes may be provided according to maternal needs and clinical judgment, but participants do not receive the structured multicomponent integrated intrapartum supportive care program. During the second stage of labor, pushing begins after full cervical dilation according to the attending clinical team's immediate pushing practice.

Первичные конечные точки

  • Duration of the first and second stages of labor [Срок оценки: From the onset of active labor to the delivery of the fetus.]
Вторичные конечные точки (3)
  • Caesarean Section Rate [Срок оценки: During labor and delivery]
  • Instrumental Vaginal Delivery Rate [Срок оценки: During delivery]
  • Augmentation Rate [Срок оценки: During labor]

Критерии участия

Inclusion Criteria:low-risk pregnant women aged 18 years or older with a singleton, term pregnancy (37-42 weeks), spontaneous labor onset, and planning to receive low-dose epidural analgesia.

Exclusion Criteria: Exclusion Criteria: multiple gestation, non-cephalic presentation, known major fetal anomalies, planned cesarean birth, contraindications to vaginal birth, contraindications to maternal mobility or epidural analgesia, or inability to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 1 центр
  • Taiwan Adventist Hospital — Taipei

Идентификаторы

NCT: NCT07663500 · 2024E02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗