Clinical trial NCT02478385: Birth Environment of the Future
Official title: Birth Environment of the Future - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Birth environment
oxytocin
epidural
analgesia
home-like
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 680
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inducted delivery

Primary outcomes:
measure: No. of women receiving oxytocin stimulation during Labour
timeFrame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes
Secondary outcomes:
measure: Duration of labour
timeFrame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes
measure: Pain relieving interventions
timeFrame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes
Other outcomes:
measure: Evaluation of woman-centred care during labour and childbirth
timeFrame: Six weeks after delivery a questionaire is e-mailed to the women
measure: Paternal evaluation of the labour room environment
timeFrame: Two weeks after delivery a questionnaire is e-mailed to the father
Locations:
city: Herning
country: Denmark
facility: Department of gynaecology and obstetrics, Herning Hospital
Study officials:
affiliation: Department of Gynecology and Obstetrics at Herning, Denmark
name: Iben Lorentzen, Midwife
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gynecology and Obstetrics at Herning, Denmark
name: Finn F Lauszus, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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. doi: 10.1002/14651858.CD000012.pub2.
citation: 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.