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Birth Environment of the Future

Birth Environment of the Future - a Randomised Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02478385
Enrollment
680
Registered
2015-06-23
Start date
2015-05-31
Completion date
2018-08-31
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Birth environment, oxytocin, epidural, analgesia, home-like

Brief summary

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

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.

Interventions

OTHERSupportive care in a specially designed labour room

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

Sponsors

Herning Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inducted delivery

Design outcomes

Primary

MeasureTime frameDescription
No. of women receiving oxytocin stimulation during LabourFrom allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutesNo 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

MeasureTime frameDescription
Duration of labourFrom allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutesMinutes of stay in labour room until delivery is registered in separate data sheet with time of arrival and time of delivery
Pain relieving interventionsFrom allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutesInterventions with epidural and pudendal analgesia are registered in the electronic patient journal

Other

MeasureTime frameDescription
Evaluation of woman-centred care during labour and childbirthSix weeks after delivery a questionaire is e-mailed to the womenWoman-centred care during labour and childbirth questionnaire
Paternal evaluation of the labour room environmentTwo weeks after delivery a questionnaire is e-mailed to the fatherQuestionaire in process of making

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026