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临床试验/NCT02478385
NCT02478385已完成不适用

Birth Environment of the Future - a Randomised Controlled Study

Herning Hospital2 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
680
试验地点
2
主要终点
No. of women receiving oxytocin stimulation during Labour

研究概览

简要总结

The main purpose of this study is to explore the impact of the birth environment on women's birth experience and relevant birth outcomes in the experimental Labour room compared to a standard Labour room.

详细描述

In the last decade, there has been an increased interest in exploring the impact of the birth environment on midwifery practice and the women's birth experiences. Results from these studies show that a home-like birth environment has positive effects on both midwifery practice and the birth experience. The hormone oxytocin that causes contractions during labour may play an important role in this context. The hormone is released when being in a safe, secure and confident environment. Therefore, it is a reasonable assumption that the birth environment also has an impact on birth outcomes.

To investigate this assumption one traditional labour room was transformed to an experimental labour room. The design of the room is inspired by knowledge from evidence-based healthcare design, which describes bringing nature into the room. Furthermore, it is possible for the parents to design their own birth setting by choosing atmosphere through sound, light and nature scenes.

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
Single (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

  • primiparas with a singleton pregnancy
  • Gestational age 37-42
  • speaks and understands Danish

排除标准

  • Inducted delivery

研究组 & 干预措施

Birth environment labour room

Active Comparator

Supportive care of labour room designed with special attention on sound and light effects, covering medical devices and insulation from outside noise

干预措施: Supportive care in a specially designed labour room (Other)

Labour in a standard labour room

Placebo Comparator

The woman gives labour in a standard labour room

干预措施: Supportive care in a specially designed labour room (Other)

结局指标

主要结局

No. of women receiving oxytocin stimulation during Labour

时间窗: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes

No of women augmented with oxytocin drip. The intervention is registered in the electronic patient journal. The duration in time (date,hours,minutes) of oxytocin treatment is registered in the electronic journal log

次要结局

  • Pain relieving interventions(From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes)
  • Duration of labour(From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes)

研究者

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

Iben Lorentzen

Midwife, Master in Health Hummanities (MHH)

Herning Hospital

研究点 (2)

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