Birth Environment of the Future

Birth Environment of the Future - a Randomised Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Supportive care in a specially designed 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.

• Study Type: Interventional
• Enrollment (Actual): 680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Department of gynaecology and obstetrics, Herning Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inducted delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Birth environment labour room; 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; Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards
Placebo Comparator: Labour in a standard labour room; The woman gives labour in a standard labour room	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Paternal evaluation of the labour room environment	Questionaire in process of making	Two weeks after delivery a questionnaire is e-mailed to the father

Collaborators and Investigators

• Sponsor: Herning Hospital
• Investigators: Principal Investigator: Iben Lorentzen, Midwife, Department of Gynecology and Obstetrics at Herning, Denmark; Study Chair: Finn F Lauszus, MD, Department of Gynecology and Obstetrics at Herning, Denmark

Publications and helpful links

General Publications

• Overgaard C, Fenger-Gron 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.
• 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.
• 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. doi: 10.1002/14651858.CD000012.pub2.
• Lorentzen I, Andersen CS, Jensen HS, Fogsgaard A, Foureur M, Lauszus FF, Nohr EA. Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience. Contemp Clin Trials Commun. 2019 Feb 15;14:100336. doi: 10.1016/j.conctc.2019.100336. eCollection 2019 Jun. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100690.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: oxytocin; analgesia; epidural; Birth environment; home-like
• Other Study ID Numbers: fremtidensfødemiljø