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

Abstract

BackgroundAn 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/designFollowing 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.DiscussionThe findings aim to guide the design of birthing rooms that contribute to optimal quality of hospital-based maternity care.Trial registrationClinicalTrials.gov NCT03948815. Registered 13 May 2019—retrospectively registered.

Women’s Experiences of Physical Features in a Specially Designed Birthing Room: A Mixed-Methods Study in Sweden

“…Women agreeing to participate in the RCT study were randomized to care either in a regular birthing room or in a refurbished birthing room, the so called new room with more physical features to increase the adaptation of the room to personal wishes and needs. A study protocol of the RCT has been published ( Berg et al, 2019 ). The study took place between January 2019 and October 2020, with some episodes of disruptions due to consequences of the COVID-19 pandemic situation and some technical problems.…”

The birthing room and its influence on the promotion of a normal physiological childbirth - a qualitative interview study with midwives in Sweden

“…This study is part of the Room4Birth research project, which aims to extend knowledge on the design of the birthing room and its influence on labour and birth (Berg et al, 2019 ).…”

Evaluation of Functional and Environmental Factors in Spanish Acute-care Hospital Design = Evaluación de los factores funcionales y ambientales en el diseño de hospitales de agudos españoles

“…give birth [81][82][83]. Design factors of the labour environment might affect the outcomes of giving birth, which will be remembered by women throughout their lives and condition the women's birth decisions for future pregnancies [81,84,85]. A supportive environment where women feel relaxed and empowered impacts positively on the birth process [81,86].…”

“…Design factors of the labour environment might affect the outcomes of giving birth, which will be remembered by women throughout their lives and condition the women's birth decisions for future pregnancies [81,84,85]. A supportive environment where women feel relaxed and empowered impacts positively on the birth process [81,86]. On the contrary, an unsettling atmosphere might inhibit oxytocin release and interrupt the natural labour process [81].…”

“…A supportive environment where women feel relaxed and empowered impacts positively on the birth process [81,86]. On the contrary, an unsettling atmosphere might inhibit oxytocin release and interrupt the natural labour process [81]. This might result in an increase in medical intervention, higher rates of synthetic oxytocin usage for augmentation of labour, and elevated percentages of caesarean sections [81][82][83]86,87].…”