Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mode of delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Maternal age ≥ 18 years' old
- •Oxytocin administration initiated or renewed during second stage of labor
排除标准
- •Maternal age < 18 years' old
- •Multiple gestation pregnancy
- •Known fetal malformations
- •Uterine scar
研究组 & 干预措施
Immediate oxytocin
This arm will receive oxytocin when entering 2nd stage (full dilation)
干预措施: Oxytocin (Drug)
Delayed oxytocin
This arm will receive oxytocin one hour after entering 2nd stage (full dilation)
干预措施: Oxytocin (Drug)
结局指标
主要结局
Mode of delivery
时间窗: Delivery
Vaginal or instrumental or cesarean
次要结局
- intrapartum fever(Delivery or 48 hours postpartum)
- Postpartum hemorrhage(Delivery)
- Neonatal pH(Delivery)
- Neonatal Apgar score(Delivery)
- Admission of the neonate to neonatal intensive care unit(Immediate postpartum, up to 5 days.)
- 2nd stage duration(Delivery)
- Meconium stain(Delivery)
- FHR decelerations(Delivery)
研究者
Gal Bachar MD
Doctor of OBGYN
Rambam Health Care Campus
