Effect of alternatively designed hospital birthing rooms on the rate of vaginal births: Multicentre randomised controlled trial Be-Up.

BACKGROUND: There is limited research into the effects of the birth environment on birth outcomes. AIM: To investigate the effect of a hospital birthing room designed to encourage mobility, self-determination and uptake of upright maternal positions in labour on the rate of vaginal births. METHODS: The multicentre randomised controlled trial Be-Up, conducted from April 2018 to May 2021 in 22 hospitals in Germany, included 3719 pregnant women with a singleton pregnancy in cephalic position at term. In the intervention birthing room, the bed was removed or covered in a corner of the room and materials were provided to promote upright maternal positions, physical mobility and self-determination. No changes were made in the control birthing room. The primary outcome was probability of vaginal births; secondary outcomes were episiotomy, perineal tears degree 3 and 4, epidural anaesthesia, "critical outcome of newborns at term", and maternal self-determination (LAS). ANALYSIS: intention-to-treat. FINDINGS: The rate of vaginal births was 89.1 % (95 % CI 87.5-90.4%; n = 1836) in the intervention group and 88.5 % (95 % CI 87.0-89.9 %; n = 1863) in the control group. The risk difference in the probability of vaginal birth was + 0.54 % (95 % CI - 1.49 % to 2.57 %), the odds ratio was 1.06 (95 % CI 0.86-1.30). Neither the secondary endpoints nor serious adverse events showed significant differences. Regardless of group assignment, there was a significant association between upright maternal body position and maternal self-determination. CONCLUSION: The increased vaginal birth rates in both comparison groups can be explained by the high motivation of the women and the staff.

Methodological challenges and solution strategies during implementation of a midwife-led multicenter randomized controlled trial (RCT) in maternity hospitals.

BACKGROUND: Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. METHODS: The aim is to describe the key methodological and organizational challenges in conducting a multicenter study in maternity wards and the solution strategies applied to them. In particular, project-related and process-oriented challenges for hospital staff are considered. The exemplarily presented randomized controlled trial "BE-UP" investigates the effectiveness of an alternative design of a birthing room on the rate of vaginal births and women-specific outcomes. RESULTS: The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria, and strategies to offer continuous support in trial implementation must be mapped out. 2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual digital real-time randomization: In addition to instructing maternity teams, appropriate measures for technical failure must be provided. 4) The standardized birthing room: The complex intervention is to be implemented according to the study protocol yet adapted to the prevailing conditions in the delivery rooms. 5) GCP-compliant documentation: midwives and obstetricians will be instructed in high-quality data collection, supported by external monitoring throughout the trial. CONCLUSION: Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial's requirements. TRIAL REGISTRATION: The BE-UP study was registered on 07/03/ 2018 in the German Register for Clinical Trials under Reference No. DRKS00012854 and can also be found on the International Clinical Trials Registry Platform (ICTRP) (see https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS0001285 ).