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临床试验/NCT03948815
NCT03948815Unknown不适用

Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial

Göteborg University1 个研究点 分布在 1 个国家目标入组 1,268 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,268
试验地点
1
主要终点
Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience

研究概览

简要总结

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This study will measure and compare effects and experiences of two types of birthing rooms.

详细描述

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This RCT project measures and compares effects and experiences of two types of birthing rooms at one Labour ward in Sweden. A qualitative ethnografic studu will assess how women interact with the birthing rooms and its physical objects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • pregnant women
  • Robson 1 classified, i.e. nulliparous, single Pregnancy >37 weeks, cephalic presentation, sponatanous Labour start
  • speak, understand Swedish, English, arabic or somali or have an interpreter present
  • Active phase of Labour: 2 of these 3 criteria fulfilled: sponatanous rupture of membranes, 2-3 painful contractions in 10 minutes; cervix dilated >3-4 cm or effaced and open >1cm

排除标准

  • induced Labour
  • planned caesarean section
  • multiple gestation
  • lack of informed written consent
  • not Speaking Swedish, Egmnlish, Arabic or Somali

结局指标

主要结局

Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience

时间窗: within 2 hours after birth

Use of oxytocin for augmentation of Labour, Spontaneous vaginal birth, normal Postpartum haemorrhage, Childbirth experience

次要结局

未报告次要终点

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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