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临床试验/NCT03381495
NCT03381495Unknown不适用

The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Deng Dongrui1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月16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
发起方
入组人数
200
试验地点
1
主要终点
Labor duration

研究概览

简要总结

Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy and full term pregnant women

排除标准

  • the pregnant women with complications

研究组 & 干预措施

Epidural analgesia during labor

Experimental

The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.

干预措施: Ropivacaine Hydrochloride, Sufentanil (Drug)

结局指标

主要结局

Labor duration

时间窗: At the end of the delivery

Duration of three stages of labor.

次要结局

  • 1 minute Apgar index(1 minute after the infant is born)
  • 5 minute Apgar index(5 minutes after the infant is born)
  • Visual Analogue Scores(VAS)(5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.)
  • Modified Bromage scores(5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.)
  • Postpartum depression(3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.)
  • The mode of delivery(At the end of delivery)

研究者

发起方
Deng Dongrui
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deng Dongrui

professor,chief doctor

Tongji Hospital

研究点 (1)

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