Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
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: Oxytocin.
- Кому может быть актуально
- Состояния в реестре: Delivery Complication, Cesarean Delivery Affecting Fetus. 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
- Израиль
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Обзор
Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.
Подробное описание
Cesarean delivery (CD) is one of the most common surgeries performed worldwide. In the last few decades, its rate has steadily increased worldwide, leading to an increase in maternal morbidity and mortality compared to vaginal delivery (VD)1. In 2014, the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery, allowing an additional hour of pushing during the 2nd stage of labor for both nulliparous and multiparous women before diagnosing prolonged 2nd of labor2-4.
Prolonged 2nd stage is especially common among nulliparous women5, and is defined as more than three hours of pushing6, or four hours for women with a regional anesthesia. Prolonged 2nd stage has been shown to be associated with maternal adverse outcomes, such as assisted-vaginal delivery, CD, and postpartum hemorrhage (PPH)7,8, and neonatal adverse outcomes such as low 5-minute Apgar score, and NICU admissions9.
Oxytocin is the primary and the most widely used pharmacological agent for induction and augmentation of labor10. Administrating oxytocin during labor is a common practice and is used to intensify contractions and decrease the chances of a non-progressive labor and associated adverse outcomes11,12. Despite its extensive use, there are several protocols which varies between different countries and obstetric wards. Likewise, there is no consensus regarding the duration or dosage of oxytocin infusion during labor, and especially during the 2nd stage of labor13.
The study will assess the optimal time initiation of Oxytocin during the 2nd stage of labor, and its association to mode of delivery, and adverse maternal and neonatal outcomes.
Вмешательства
- Препарат Oxytocin
Native oxytocin analog
Первичные конечные точки
- Mode of delivery [Срок оценки: Delivery]
Вторичные конечные точки (8)
- 2nd stage duration [Срок оценки: Delivery]
- intrapartum fever [Срок оценки: Delivery or 48 hours postpartum]
- Meconium stain [Срок оценки: Delivery]
- Postpartum hemorrhage [Срок оценки: Delivery]
- FHR decelerations [Срок оценки: Delivery]
- Neonatal pH [Срок оценки: Delivery]
- Neonatal Apgar score [Срок оценки: Delivery]
- Admission of the neonate to neonatal intensive care unit [Срок оценки: Immediate postpartum, up to 5 days.]
Критерии участия
Критерии включения
- Singleton pregnancy
- Maternal age ≥ 18 years' old
- Oxytocin administration initiated or renewed during second stage of labor
Критерии исключения
- Maternal age < 18 years' old
- Multiple gestation pregnancy
- Known fetal malformations
- Uterine scar
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Израиль · 1 центр
- Rambam medical health campus — Haifa
Идентификаторы
NCT: NCT06181396 · 0061-22-RMB