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Идёт набор NCT04303702

The Role of Oxytocin in the Second Stage of Labor

Без фазы С лечением Labor Complication

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: Continue Oxytocin, Discontinue Oxytocin.
Кому может быть актуально
Состояния в реестре: Labor Complication. Базовые параметры: Без ограничений · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)

Обзор

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Подробное описание

Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Вмешательства

  • Препарат Continue Oxytocin
    The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functio
  • Другое Discontinue Oxytocin
    Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.

Первичные конечные точки

  • Second stage duration [Срок оценки: During admission for delivery]
Вторичные конечные точки (7)
  • Rate of operative delivery [Срок оценки: During admision for delivery]
  • Rate of Postpartum hemorrhage [Срок оценки: During admission for delivery]
  • Estimated blood loss [Срок оценки: During admission for delivery]
  • Rate of chorioamnionitis during the second stage of labor [Срок оценки: During admission for delivery]
  • Rate of endometritis [Срок оценки: During admission for delivery]
  • Rate of severe perineal laceration [Срок оценки: During admission for delivery]
  • Rate of composite neonatal morbidity [Срок оценки: During admission for delivery]

Критерии участия

Критерии включения

  • Nulliparous pregnant women >/= 37 weeks gestation
  • Singleton pregnancies
  • Admission for induction of labor or spontaneous labor

Критерии исключения

  • Multiple gestations
  • Multiparous patients
  • Patients with major fetal anomalies
  • Not on oxytocin at the time of complete cervical dilation
  • Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
  • Maternal medical condition that prohibits prolonged second stage

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Barnes Jewish Hospital — St Louis

Идентификаторы

NCT: NCT04303702 · 201909112

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗