跳至主要内容
临床试验/NCT04391075
NCT04391075已完成不适用

Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block

Oslo University Hospital0 个研究点目标入组 1,007 人开始时间: 2017年1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
1,007
主要终点
Childbirth experience

研究概览

简要总结

This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.

详细描述

Pudendal block is used when there is a need to alleviate pain in the final stage of labour:

  • From fully dilated cervix to delivery of the child.
  • Associated with pain as the foetus rotates and descends through the pelvis.
  • End of second stage: the perineum dilates as the child is being born.

Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.

The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Norwegian-speaking/reading
  • Primiparity
  • Single pregnancy
  • Vaginal birth
  • Cephalic presentation
  • Age ≥18 years

排除标准

  • Transferre from midwifery-led birth unit
  • Allergy to local anaesthesia
  • Not valid data on pudendal block

结局指标

主要结局

Childbirth experience

时间窗: Responds to questionnaire 4-12 weeks after delivery.

Childbirth experience questionnaire (CEQ), total score on a scale from 1.0 to 4.0. Higher score means better experience.

Urinary retention

时间窗: 3 hours

Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.

次要结局

  • Pain, obstetric(Responds to questionnaire 4-12 weeks after delivery.)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Åsa Waldum

Midwife/PhD student

Oslo University Hospital

相似试验