gms | German Medical Science

Background: A major objective of the German National Health Goal „Gesundheit rund um die Geburt“ (Health before, during and after birth) is the advancement of vaginal births [1]. A complex intervention, such as an alternative design of the birthing room, might have the potential to increase the likelihood of vaginal birth and at the same time to decrease the rate of caesarean sections [2]. However, there is as of yet no international or national study confirming the independent effect of the intervention "alternatively designed birthing room" on mode of birth. The randomised controlled multicentre trial "BE-UP" was designed to address this lack of knowledge. If the BE-UP trial demonstrates an independent effect, the intervention has the capability to be nationally implemented in hospitals' obstetric units at minimal cost and burden (translation into practice).

Aim: The trial's objective is to test the independent effect of an alternatively designed birthing room on maternal and neonatal outcomes in women with a singleton cephalic presentation at term. In this presentation, the challenges will be discussed which the study team met when planning the RCT, taking into consideration the qualitative requirements by the ICH-Good Clinical Practice E6 Guideline [3].

Methods: For the BE-UP trial, about 4,000 women will be recruited in 12 hospitals (with obstetric units) in 5 federal states during the course of 23 months. By way of an online randomization procedure, they will be assigned either to the intervention group (alternatively designed birthing room: no centrally located delivery bed, instead devices and materials to foster mobility, relaxation, self-determination and an upright body posture) or the control group (usual birthing room with a centrally positioned delivery bed). In both study groups the labouring women will be professionally cared for by midwives and obstetricians – without any study related specifications for performance – taking into consideration the women's individual situation.

The primary outcome is the probability of vaginal birth; secondary outcomes are the labouring woman's self-determination, rate of medical interventions, perinatal morbidity, maternal morbidity and maternal quality of life in the postpartum period. A health economic analysis evaluates the intervention's cost effectiveness.

With regards to client safety and data quality, the trial that lasts 3 years has been planned according to the highest possible standard according to the ICH-Good Clinical Practice E6 Guideline [3]. Evaluated in two phases through peer review, the RCT tagged with the project reference number, KS2014-66, has been recommended for funding by the German Education and Research Ministry (BMBF). The final application for a research grant from the BMBF funding programme "Clinical trials of high relevance for patients' care" (2016) had been filed in June 2017 with an intended start of the trial in October 2017.

Results: Methodical challenges that were faced and were to be met during the planning stage of the BE-UP trial will be discussed: the design of the intervention, definition of endpoint measures, randomization, data collection as well as monitoring of trial progression and data quality.

Conclusions: Discussing methodical aspects of the BE-UP trial may provide researchers planning a randomised controlled multicentre clinical trial in the field of midwifery care with helpful insights.

Ethical criteria and conflict of interests: The research will be submitted to an ethics committee from October 2017. The study is funded by the Federal Ministry of Education and Research (BMBF). There is no conflict of interest.