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临床试验/NCT03980951
NCT03980951已完成不适用

A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.

Wahba bakhet4 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
4
主要终点
epidural Local anesthetic consumption

研究概览

简要总结

The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural

The secondary objective of this study is to compare the and fetomaternal 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous parturient
  • Singleton, vertex gestation at term (37-42 weeks)
  • Less than 5 cm dilation
  • request an epidural technique for labor analgesia

排除标准

  • Hypersensitivity to local the study drugs
  • Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
  • Any contraindication to the administration of an epidural technique
  • Risk factor for cesarean delivery.
  • fetal anomalies

结局指标

主要结局

epidural Local anesthetic consumption

时间窗: 1 year

次要结局

  • incidence of fetal bradycardia(1 year)
  • Maternal hypotension(1 year)
  • incidence of maternal pruritus(1 year)
  • labour pain scores(1 year)

研究者

发起方
Wahba bakhet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wahba bakhet

Director

Ain Shams University

研究点 (4)

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