Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden
Journal article, 2019

BACKGROUND: An important prerequisite for optimal healthcare is a secure, safe and comfortable environment. There is little research on how the physical design of birthing rooms affects labour, birth, childbirth experiences and birthing costs. This protocol outlines the design of a randomised controlled superiority trial (RCT) measuring and comparing effects and experiences of two types of birthing rooms, conducted in one labour ward in Sweden. METHODS/DESIGN: Following ethics approval, a study design was developed and tested for feasibility in a pilot study, which led to some important improvements for conducting the study. The main RCT started January 2019 and includes nulliparous women presenting to the labour ward in active, spontaneous labour and who understand either Swedish, Arabic, Somali or English. Those who consent are randomised on a 1:1 ratio to receive care either in a regular room (control group) or in a newly built birthing room designed with a person-centred approach and physical aspects (such as light, silencer, media installation offering programmed nature scenes with sound, bathtub, birth support tools) that are changeable according to a woman's wishes (intervention group). The primary efficacy endpoint is a composite score of four outcomes: no use of oxytocin for augmentation of labour; spontaneous vaginal births (i.e. no vaginal instrumental birth or caesarean section); normal postpartum blood loss (i.e. bleeding < 1000 ml); and a positive overall childbirth experience (7-10 on a scale of 1-10). To detect a difference in the composite score of 8% between the groups we need 1274 study participants (power of 80% with significance level 0.05). Secondary outcomes include: the four variables in the primary outcome; other physical outcomes of labour and birth; women's self-reported experiences (the birthing room, childbirth, fear of childbirth, health-related quality of life); and measurement of costs in relation to the hospital stay for mother and neonate. Additionally, an ethnographic study with participant observations will be conducted in both types of birthing rooms. DISCUSSION: The findings aim to guide the design of birthing rooms that contribute to optimal quality of hospital-based maternity care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03948815. Registered 13 May 2019-retrospectively registered.

Labour

Birthing room

Randomised controlled trial

Person-centred care

Birth environment

Author

Marie Berg

Sahlgrenska University Hospital

University of Gothenburg

Lisa Goldkuhl

Sahlgrenska University Hospital

University of Gothenburg

Christina Nilsson

University of Borås

Helle Wijk

Sahlgrenska University Hospital

University of Gothenburg

Centre for Healthcare Architecture (CVA)

Chalmers, Architecture and Civil Engineering

Hanna Gyllensten

University of Gothenburg

Göran Lindahl

Centre for Healthcare Architecture (CVA)

Chalmers, Architecture and Civil Engineering, Building Design

Kerstin Uvnäs Moberg

Swedish University of Agricultural Sciences (SLU)

Cecily Begley

Trinity College Dublin

Trials

1745-6215 (ISSN)

Vol. 20 1 629

Subject Categories

Health Care Service and Management, Health Policy and Services and Health Economy

Nursing

Obstetrics, Gynecology and Reproductive Medicine

DOI

10.1186/s13063-019-3765-x

PubMed

31744523

More information

Latest update

12/3/2019