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.
Highlights
An important prerequisite for optimal healthcare is a secure, safe and comfortable environment
The findings aim to guide the design of birthing rooms that contribute to optimal quality of hospitalbased maternity care
An ongoing multicenter study in 12 labour wards in Germany will evaluate if a redesigned birthing room that facilitates mobility and upright positioning, coping with pain and personal comfort will result in a higher probability of a Methods/design Based on the lack of knowledge that was identified concerning the effect and influence of birthing room on the woman and her baby, and the likelihood that maternity wards in some countries will be in need of either reconstruction or new construction of labour wards, we identified the need to conduct a randomised controlled trial (RCT)
Summary
An important prerequisite for optimal healthcare is a secure, safe and comfortable environment. Introduction to current practice: childbirth care in Sweden In Sweden, healthcare at birth is offered only at hospitals. The aim of this care is to promote a physiologically normal birth, i.e. where labour starts spontaneously and ends in a vaginal non-instrumental birth, where mothers and babies are healthy and the mothers have a positive childbirth experience [1]. By 2018, 53.2% of first-time mothers with spontaneous labour received oxytocin infusion for labour augmentation [3] This high level of intervention in otherwise normal labour warrants increased costs due to increased demands on personnel during the birth itself, prolonged hospital stay, and more frequent readmission in the postnatal period [4]. As that population is usually at greater risk of pregnancy and labour complications, and differs considerably from the Swedish population, maternity care in Sweden has not changed practice as a result
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