Birth Environment of the Future

Pregnancy Clinical Trial

Official title:

Birth Environment of the Future - a Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478385
• Other study ID #: fremtidensfødemiljø
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• primiparas with a singleton pregnancy

• Gestational age 37-42

• speaks and understands Danish

Exclusion Criteria:

• Inducted delivery

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Supportive 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

Locations

Country	Name	City	State
Denmark	Department of gynaecology and obstetrics, Herning Hospital	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Foureur M, Davis D, Fenwick J, Leap N, Iedema R, Forbes I, Homer CS. The relationship between birth unit design and safe, satisfying birth: developing a hypothetical model. Midwifery. 2010 Oct;26(5):520-5. doi: 10.1016/j.midw.2010.05.015. Epub 2010 Aug 7. — View Citation

Hodnett ED, Downe S, Edwards N, Walsh D. Home-like versus conventional institutional settings for birth. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD000012. Review. Update in: Cochrane Database Syst Rev. 2010;(9):CD000012. — View Citation

Overgaard C, Fenger-Grøn M, Sandall J. The impact of birthplace on women's birth experiences and perceptions of care. Soc Sci Med. 2012 Apr;74(7):973-81. doi: 10.1016/j.socscimed.2011.12.023. Epub 2012 Jan 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of woman-centred care during labour and childbirth	Woman-centred care during labour and childbirth questionnaire	Six weeks after delivery a questionaire is e-mailed to the women
Other	Paternal evaluation of the labour room environment	Questionaire in process of making	Two weeks after delivery a questionnaire is e-mailed to the father
Primary	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	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
Secondary	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