Birth Environment of the Future

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Birth Environment of the Future - a Randomised Controlled Study

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Supportive care in a specially designed labour room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primiparas with a singleton pregnancy Gestational age 37-42 speaks and understands Danish Exclusion Criteria: Inducted delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Birth environment labour room<br>Supportive care of labour room designed with special attention on sound and light effects, covering medical devices and insulation from outside noise | Other: Supportive care in a specially designed labour room<br>* Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards<br>|
| Placebo Comparator: Labour in a standard labour room<br>The woman gives labour in a standard labour room | Other: Supportive care in a specially designed labour room<br>* Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No. of women receiving oxytocin stimulation during Labour | 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 | From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labour | Minutes of stay in labour room until delivery is registered in separate data sheet with time of arrival and time of delivery | From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes | 
| Pain relieving interventions | Interventions with epidural and pudendal analgesia are registered in the electronic patient journal | From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth environment, oxytocin, epidural, analgesia, home-like