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).

Resuscitation 2

Within 5 years of its detection, oxygen was applied to resuscitate neonates from 1780 onwards. It rapidly gained general acceptance, and infiltrated delivery rooms and, a century later, neonatal special care units. After over 240 years without scientific evidence, the use of oxygen for neonatal resuscitation is being questioned. Continuous distending airway pressure for oxygen administration was available at the beginning of the 20th century, but was not widely accepted. Alkali and analeptic drugs gained widespread but short-lived use after World War II.

Avaliação de maternidades: uma revisão integrativa da literatura

Objetivo: Analisar a produção científica sobre a avaliação das maternidades incluindo elementos de estrutura, processos e resultados. Métodos: revisão integrativa da literatura a partir das bases MEDLINE, SciELO, CINAHL e LILACS entre os anos de 2008 e 2018. Os descritores utilizados foram: delivery rooms; maternal and child health; hospital maternity; birthing centers; program evaluation; health services; outcome assessment (health care). Resultados: A amostra final foi constituída por 17 artigos científicos. A maioria dos estudos atribuíram a estrutura como forma de avaliação por meio de domínios como infraestrutura adequada, disponibilidade de equipamentos, medicamentos e recursos humanos capacitados e avaliaram ambientes neonatais. Em segundo lugar, a qualidade das maternidades foi atribuída à satisfação das mulheres. Conclusão: indicadores de estrutura, processos e resultados são elementos constitutivos da avaliação em saúde nas maternidades, que podem ser avaliados de forma multidimensional e considerar a satisfação das mulheres.

Midwives’ experiences of witnessing traumatic hospital birth events: A qualitative study

Aims: The aim of this study was to investigate in detail the traumatic birth experiences of midwives in the delivery rooms, and their attitudes, reactions, and coping strategies. Methods: The design of the study is descriptive and the purposive sampling method was used. This approach is ideal for a preliminary exploration of the nature of a phenomenon. Between October 2018 and January 2019, semi-structured interviews were conducted with a purposeful sample of midwives. The research was carried out with the participation of 29 midwives, who work in labour and birth room. They were asked to describe a particular stressful situation they had experienced during the birth process, their emotions about the event, and their coping strategies and support systems. All interviews were digitally recorded, stored in a database, and transferred to MAX Qualitative Data Analysis 18.1.0 for analysis. Results: As a result of the content analysis, three main themes emerged: Psychological impact, defensive practice, and expectations from the hospital. It was revealed that, after the traumatic birth, midwives experienced highly emotional exhaustion in the form of sadness, flashbacks, guilt, fear, and empathy, and that they performed an increasingly defensive practice. Besides, midwives explicitly stated that they were not prepared enough for traumatic events and that most traumatic births were simply ignored in their workplace. Eventually, it was determined that midwives received support mostly from their colleagues in case of a traumatic birth. Conclusion(s): Midwives need to feel valued and be supported by their institutions in coping with emotional stress. Therefore, performing clinical inspections by experienced or specialist midwives may serve as a supporting framework for reducing defensive interventions.

Methodological Challenges and Solution Strategies During Implementation of a Midwife-led Multicentre Randomized-controlled Trial (RCT) in Maternity Hospitals

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.

Rates of Cesarean Conversion and Associated Predictors and Outcomes in Planned Vaginal Twin Deliveries

Objective Twin vaginal deliveries (VDs) are often performed in the operating room (OR) given the risk of conversion to cesarean delivery (CD) for the aftercoming twin. We aim to investigate the rates of conversion to CD for planned twin VDs and identify predictors and outcomes of conversion. Study Design A retrospective cohort study of all women who underwent a planned twin VD at two large academic medical centers over 4 years. Demographic and outcome data were chart abstracted. Various statistical tests were used to evaluate the influence of perinatal variables on mode of delivery and identify possible predictors of conversion. Results Eight hundred and eighty-five twin deliveries were identified, of which 725 (81.9%) were possible candidates for VD. Of those, 237 (32.7%) underwent successful VD of twin A. Ninety-five (40.1%) had a nonvertex second twin at time of delivery. Conversion to CD occurred in 10 planned VDs (4.2%). Conversions were higher with spontaneous labor (relative risk [RR]: 2.1; 95% confidence interval [CI] 1.6–2.7; p = 0.003), and having an intertwin delivery interval greater than 60 minutes (RR: 5.1; 95% CI: 2.5–10.8; p < 0.001). Nonvertex presentation of twin B, type of delivery provider, or years out in practice of delivery provider were not significantly different between groups. There were no significant differences in neonatal outcomes between VD and conversion groups. There was a significant association between use of forceps for twin B and successful VD (p = 0.02), with 84.6% in the setting of a nonvertex twin B. Conclusion Successful VD was achieved in planned VD of twins in 95.8% of cases, and there were no significant differences in maternal and fetal outcomes between successful VD and conversion to CD for twin B. With the optimal clinical scenario and shared decision-making, performing vaginal twin deliveries in labor and delivery rooms should be discussed. Key Points