Zusammenfassung Das 9. Nationale Gesundheitsziel „Gesundheit rund um die Geburt“ und evidenzbasierte Leitlinien fordern die Förderung der physiologischen Geburt. Das RCT „Be-Up: Geburt aktiv“ untersucht die Wirkung eines alternativ gestalteten Gebärraums auf die Rate vaginaler Klinikgeburten. Die Umsetzung des RCT und die Rekrutierung von 3.800 Studienteilnehmerinnen sind nur durch die Teilnahme der 17 Be-Up-Kliniken möglich. Die Ergebnisse werden für Klinikpersonal, Entscheidungsträger und die Hebammenwissenschaft von Interesse sein.
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).
Background: RCTs with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (ICH-GCP guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand, such as “peak hours” of births and a high work burden for midwives and obstetricians. Moreover, in Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods: The randomised controlled trial “BE-UP” tests the effectiveness of an alternative birthing room on the rate of vaginal births and woman-oriented outcomes. In the process of implementing the trial in 17 obstetrical units and in the endeavour to reach the calculated sample size of 3,800 women, the research team encountered a variety of unexpected challenges. The aim is to describe in greater detail the methodical and organisational challenges and to inform about the research team’s strategies to overcome them.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: besides instructing the maternity teams appropriate measures for technical failure must be provided.4) The standardized birthing room: the complex intervention is to be implemented according to study protocol, yet adapted to the prevailing conditions in the delivery rooms.5) GCP-compliant documentation: midwives and obstetricians is to 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.
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