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临床试验/NCT04303702
NCT04303702招募中不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Second stage duration

研究概览

简要总结

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

详细描述

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.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Discontinue Oxytocin

Other

干预措施: Discontinue Oxytocin (Other)

Continue Oxytocin

Active Comparator

干预措施: Continue Oxytocin (Drug)

结局指标

主要结局

Second stage duration

时间窗: During admission for delivery

Time interval from complete cervical dilation to delivery of fetus

次要结局

  • Rate of Postpartum hemorrhage(During admission for delivery)
  • Rate of composite neonatal morbidity(During admission for delivery)
  • Rate of chorioamnionitis during the second stage of labor(During admission for delivery)
  • Rate of severe perineal laceration(During admission for delivery)
  • Rate of operative delivery(During admision for delivery)
  • Estimated blood loss(During admission for delivery)
  • Rate of endometritis(During admission for delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nandini Raghuraman

Assistant Professor

Washington University School of Medicine

研究点 (1)

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