Room 4 Birth - 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

Abstract

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 ethical approval, a study design was developed and tested for feasibility in a pilot study which led to some important improvements for the conduction of the study. The main RCT started January 2019 and includes nulliparous women presenting to the labour ward in active, spontaneous labour, 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-centered approach and physical aspects (such as: light, silencer, media installator offering programmed nature scenes with sound, bath tub, birth support tools) that are adaptable as a woman 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 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 selfreported 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. Identifier NCT03948815. Registered 13 May 2019 - retrospectively registrered. https://clinicaltrials.gov/ct2/results?cond=Room+4+Birth&draw=1&rank=1#rowId0. Keywords: Birth environment, Birthing room, Person-Centered Care, Labour, Randomised Controlled Trial