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.

The partner's experiences of childbirth in countries with a highly developed clinical setting: a scoping review.

BACKGROUND: In Western countries, it is common practice for a woman to be supported by a trusted person during childbirth, usually the other parent. Numerous studies have shown that this has a positive effect both on the woman's satisfaction with the birth process and on physical outcomes. However, there is little research on the birth experience of partners and their wellbeing. The aim of this review is to summarise the existing literature on partner experience, consider its quality and identify the underlying themes. METHODS: Both a systematic literature search in three databases and a manual search were conducted, for qualitative, quantitative, and mixed-methods studies from Western countries examining the experiences of partners present at a birth. RESULTS: A total of 35 studies were included. Only one study included same-sex partners (the other studies addressed fathers' experiences only) and only one validated questionnaire examining partners' birth experiences was identified. Four major themes were found to influence partners' birth experiences: (1) intense feelings, (2) role of support, (3) staff support, and (4) becoming a father. CONCLUSIONS: Partners may feel very vulnerable and stressed in this unfamiliar situation. They need emotional and informal support from staff, want to be actively involved, and play an important role for the birthing woman. To promote good attachment for parents, systematic exploration of the needs of partners is essential for a positive birth experience. Because of the diversity of family constellations, all partners should be included in further studies, especially same-sex partners.

Effects of the Covid-19 pandemic on maternity staff in 2020 - a scoping review.

In the spring of 2020, the SARS-CoV-2 virus caused the Covid-19 pandemic, bringing with it drastic changes and challenges for health systems and medical staff. Among the affected were obstetricians and midwives, whose close physical contact with pregnant women, women who recently gave birth, and their children was indispensable. In the obstetric setting, births cannot be postponed, and maternity staff had to adapt to assure obstetric safety while balancing evidence-based standards with the new challenges posed by the pandemic. This scoping review gives a comprehensive overview of the effecs the Covid-19 pandemic had on maternity staff. We followed the evidence-based approach described by Arksey & O'Malley: we searched several databases for English and German articles published between January 2020 and January 2021 that discussed or touched upon the effects the pandemic had on maternity staff in OECD countries and China. We found that structural challenges caused by the crisis and its subjective effects on maternity staff fell into two main topic areas. Structural challenges (the first main topic) were divided into five subtopics: staff shortages and restructuring; personal protective equipment and tests; switching to virtual communication; handling women with a positive SARS-CoV-2 infection; and excluding accompanying persons. The pandemic also strongly affected the staff's mental health (the second main topic.) Attempting to meet challenges posed by the pandemic while afraid of contamination, suffering overwork and exhaustion, and struggling to resolve ethical-moral dilemmas had severe negative subjective effects. Several studies indicated increased depression, anxiety, stress levels, and risk of post-traumatic stress symptoms, although the crisis also generated strong occupational solidarity. Care for pregnant, birthing, and breast-feeding women cannot be interrupted, even during a pandemic crisis that requires social distancing. Maternity staff sometimes had to abandon normal standards of obstetric care and were confronted with enormous challenges and structural adjustments that did not leave them unscathed: their mental health suffered considerably. Researchers should study maternity staff's experiences during the pandemic to prepare recommendations that will protect staff during future epidemics.

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 ).

Fear of childbirth (FOC): pregnant women's perceptions towards the impending hospital birth and coping resources - a reconstructive study.

Background: To provide obstetric care which meets the needs of pregnant women with fear of childbirth (FOC), a deeper understanding is required of the beliefs of these women regarding their impending birth and the coping resources they possess to cope with their fear.Methods: Problem-centred interviews were carried out with 12 pregnant women who self-reported high FOC. Data analysis was performed using Bohnsack's Documentary Method to reconstruct collective frames of orientation and implicit and explicit orientations in daily practice and interaction.Results: The interviewees see birth as a field of tension between the poles of naturalness and medicalization. Their need for information displays a need to be in control and fear of losing control. Medical and technological monitoring and one-to-one care promote security. Pregnant women with FOC want to know how they can contribute to a physiological birth.Conclusions: Structural, organizational and conceptual changes in obstetric care are needed to cater to the needs of pregnant women with FOC. Alongside the need for evidence-based information about non-medical and medical pain-relief as well as decision-making aids, the provision of a continuity model of midwifery care is important.

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.

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.

Support for pregnant women identified with fear of childbirth (FOC)/tokophobia - A systematic review of approaches and interventions.

BACKGROUND: providing appropriate care for pregnant women with high or severe fear of childbirth (FOC) is a challenge in midwifery care today. FOC is associated with predisposing anamnestic factors, various sociodemographic and psychosocial characteristics, and may result in serious healthrelated consequences. It is therefore important to establish which interventions may increase a woman's faith in her own ability to cope with labour and birth. AIM: to systematically identify and review studies examining interventions for relief of severe fear of childbirth in pregnancy and their underlying conceptual foundation. METHODS: a systematic literature search was performed following Cochrane Collaboration and PRISMA Statement recommendations. Inclusion criteria were: studies including pregnant women diagnosed with high or severe FOC or who requested a caesarean section due to severe FOC, studies (regardless of design) observing the effect of an intervention addressing FOC, and studies published in English. Publications addressing anxiety or stress were excluded. 377 references were screened by title and abstract. The risk of bias was assessed. FINDINGS: 19 articles referring to 15 research projects were included in the analysis. The studies show heterogeneity regarding assessment methods, type, conceptualisation and application of interventions. There is evidence that both cognitive therapy sessions and a theory-based group psychoeducation with relaxation are effective interventions. KEY CONCLUSIONS: despite methodological limitations, single or group psychoeducation sessions for nulliparous women or therapeutic conversation during pregnancy (in group or individual sessions) have the potential to strengthen women's self-efficacy and decrease the number of caesarean sections due to FOC. The theoretical validation of an intervention deepens the understanding of psychological processes in women coping with severe FOC. IMPLICATIONS FOR PRACTICE: theory-based concepts of care for both antenatal and intrapartum support of pregnant women with high or severe FOC should be developed, piloted, tested, evaluated and implemented within the given healthcare system. Midwives need to be competent to address pregnant women's fears regarding labour and birth in antenatal care. The use of a valid assessment tool to identify the level of FOC in women, even if they do not raise the issue, is recommended in routine antenatal care so that appropriate expert support can be offered. A one-on-one conversation may be feasible for those women unwilling to fill in a questionnaire. Cooperative local networks between midwives, psychologists and obstetricians qualified in psychotherapy should be established to ensure timely and effective care for women with high or severe FOC.