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

Gertrud M Ayerle, Rainhild Schäfers, Elke Mattern, Sabine Striebich, Burkhard Haastert, Markus Vomhof, Andrea Icks, Yvonne Ronniger, Gregor Seliger, Gertrud M Ayerle, Rainhild Schäfers, Elke Mattern, Sabine Striebich, Burkhard Haastert, Markus Vomhof, Andrea Icks, Yvonne Ronniger, Gregor Seliger

Abstract

Background: Caesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal 'Health in Childbirth' (Gesundheit rund um die Geburt) promote vaginal births (VBs). This randomised controlled trial (RCT) evaluates the effects of a complex intervention pertaining to the birth environment, based on the sociology of technical artefacts and symbolic interactionism. The intervention is intended to foster an upright position and mobility during labour, which lead to a higher probability of VB.

Methods/design: This study is an active controlled superiority trial with a two-arm parallel design. The complex intervention involves making changes to the birthing room to encourage an upright position and mobility of women in labour and to relax them, which may help them to cope with labour and may increase self-determination. This may result in more VBs. Included in the study are primiparae and multiparae with a singleton foetus in cephalic presentation at term planning a VB. According to the sample size calculation, 3800 women in 12 obstetrical units are to be included. Randomisation will be performed centrally and controlled by an independent coordination centre. Blinding of participants and staff is not possible. Key outcomes are VB, episiotomy, perineal tears, epidural analgesia, critical outcome of newborn at term and maternal self-determination during birth. Additionally, a health economic evaluation will be performed.

Discussion: This is the first adequately powered multicentre RCT examining the effect of a redesigned birthing room on the probability of a VB and patient-centred physical and emotional outcomes. An increase in the number of VBs by 5% from a baseline of 74% to 79% would result in 21,000 women per year experiencing a VB rather than a CS in Germany. Expected benefits are greater self-determination during labour, improved physical and emotional client-centred outcomes, fewer medical interventions and a reduction in health-care costs.

Trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00012854 . Registered on 7 March 2018.

Keywords: Birth environment; Health economic evaluation; Hospital setting; Maternal satisfaction; Midwifery; RCT; Self-determination; Vaginal birth.

Conflict of interest statement

Ethics approval and consent to participate

The ethics committee of the Medical Faculty of Martin Luther University of Halle-Wittenberg in Halle (Saale), Germany, reviewed the study protocol and associated materials (recruitment media, participant information sheet, consent form and complete CRF) and approved it on 2 February 2018. The committee’s reference number is 2017–140. Moreover, the federal states’ ethical committees responsible for the medical doctors employed at the participating hospitals approved the conduct of the study. Important protocol modifications will be communicated to all ethical committees concerned.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments (according to SPIRIT 2013 guidelines [54])

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