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Completed

NCT Number: NCT02478385

Birth Environment of the Future

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.

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Key information

Conditions

Pregnancy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of gynaecology and obstetrics, Herning Hospital

Herning, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inducted delivery

Treatment and study plan

Supportive care in a specially designed labour room

Other

Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards

Primary outcomes

  1. No. of women receiving oxytocin stimulation during Labour

    Time frame: 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

Secondary outcomes

  1. Duration of labour

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

    Minutes of stay in labour room until delivery is registered in separate data sheet with time of arrival and time of delivery

  2. Pain relieving interventions

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

    Interventions with epidural and pudendal analgesia are registered in the electronic patient journal

Other outcomes

  1. Evaluation of woman-centred care during labour and childbirth

    Time frame: Six weeks after delivery a questionaire is e-mailed to the women

    Woman-centred care during labour and childbirth questionnaire

  2. Paternal evaluation of the labour room environment

    Time frame: Two weeks after delivery a questionnaire is e-mailed to the father

    Questionaire in process of making

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Registry information

Official study title

Birth Environment of the Future - a Randomised Controlled Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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