Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial

et al. 2019

Trials

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.

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2019

Trials

“…The use of an RCT to test the rooms is a quite new approach in this field, which usually uses social science methodology. Only one pilot study conducted in Canada has been published earlier [46] and two studies are ongoing, in Denmark [47] and Germany [48]. The use of a qualitative ethnographic study will deepen understanding of the interaction between the woman and the room.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

Preprint

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: 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.

“…The environment in the intervention room has been re-conceptualised with special features and equipment, such as a bed hidden from sight by a screen or curtain, a matress on the floor, foam elements for support, a bean bag and posters depicting upright positions, and a monitor showing nature films with natural sound and music. The study will comprise 3800 women and has vaginal birth as the primary outcome [48].…”

Section: Existing Knowledge On the Effect Of Healthcare Environment Omentioning

confidence: 99%

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

et al. 2019

Preprint

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