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.

Vaginal Birth at Term - Part 2. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020).

Purpose This guideline aims to summarize the current state of knowledge about vaginal birth at term. The guideline focuses on definitions of the physiological stages of labor as well as differentiating between various pathological developments and conditions. It also assesses the need for intervention and the options to avoid interventions. The second part of this guideline presents recommendations and statements on care during the dilation and expulsion stages as well as during the placental/postnatal stage. Methods The German recommendations largely reproduce the recommendations of the National Institute for Health and Care Excellence (NICE) CG190 guideline "Intrapartum care for healthy women and babies". Other international guidelines were also consulted in individual cases when compiling this guideline. In addition, a systematic search and analysis of the literature was carried out using PICO questions where necessary, and other systematic reviews and individual studies were taken into account. For easier comprehension, the assessment tools of the Scottish Intercollegiate Guidelines Network (SIGN) were used to evaluate the quality of additionally consulted studies. Otherwise, the GRADE system was used for the NICE guideline, and the evidence reports of the IQWiG were used to evaluate the quality of the evidence. Recommendations Recommendations and statements were formulated based on identified evidence and/or a structured consensus.

Vaginal Birth at Term - Part 1. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020).

Purpose This guideline aims to summarize the current state of knowledge about vaginal birth at term. The guideline focuses on definitions of the physiological stages of labor as well as differentiating between various pathological developments and conditions. It also assesses the need for intervention and the options to avoid interventions. This first part presents recommendations and statements about patient information and counselling, general patient care, monitoring of patients, pain management and quality control measures for vaginal birth. Methods The German recommendations largely reproduce the recommendations of the National Institute for Health and Care Excellence (NICE) CG 190 guideline "Intrapartum care for healthy women and babies". Other international guidelines were also consulted in specific cases when compiling this guideline. In addition, a systematic search and analysis of the literature was carried out using PICO questions, if this was considered necessary, and other systematic reviews and individual studies were taken into account. For easier comprehension, the assessment tools of the Scottish Intercollegiate Guidelines Network (SIGN) were used to evaluate the quality of the additionally consulted studies. Otherwise, the GRADE system was used for the NICE guideline and the evidence reports of the IQWiG were used to evaluate the quality of the evidence. Recommendations Recommendations and statements were formulated based on identified evidence and/or a structured consensus.

[Quality-Assured Translation of the Wijma Delivery Expectancy Questionnaire (W-DEQ_A) into German]. / Qualitätsgesicherte Übersetzung des Wijma Delivery Expectancy Questionnaire (W-DEQ_A) ins Deutsche.

INTRODUCTION: The "Delivery Expectancy Questionnaire" by Claas Wijma et al. (W-DEQ_A), which is the most frequently used internationally to determine high levels of fear of childbirth in pregnancy, was not previously available in German. In European countries, Canada, Australia and the United States, fear of childbirth is reported to have a prevalence of 6.3 to 14.8%. Particularly, women with a fear of childbirth have an increased risk for preeclampsia, intrauterine growth retardation, and caesarean sections. METHODS: An English version of the W-DEQ_A authorized by Claas Wijma was translated and culturally adapted according to the guideline of Ohrbach et al. (INfORM). Content validity was statistically determined by means of the content validity index/average method (S-CVI/Ave). RESULTS: The translation of all text sections of the W-DEQ_A was subjected to independent appraisal. One introductory question and three items needed to be retranslated. Moreover, three items required rewording to achieve cultural equivalence. The calculated content validity yielded an "excellent" S-CVI/Ave of 0.91. CONCLUSION: The W-DEQ_A is now available in a German version for the self-assessment of fear of childbirth. It is entitled "Gedanken und Gefühle schwangerer Frauen im Hinblick auf die bevorstehende Geburt". In the form of a digital health app, the questionnaire could be prescribed and the result directly transferred to the electronic patient record.

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 ).

Caesarean Section. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/084, June 2020).

Purpose This is an official S3-guideline of the German Society of Gynaecology and Obstetrics (DGGG), the Austrian Society of Gynaecology and Obstetrics (ÖGGG) and the Swiss Society of Gynaecology and Obstetrics (SGGG). The guideline contains evidence-based information and recommendations on indications, complications, methods and care associated with delivery by caesarean section for all medical specialties involved as well as for pregnant women. Methods This guideline has adapted information and recommendations issued in the NICE Caesarean Birth guideline. This guideline also considers additional issues prioritised by the Cochrane Institute and the Institute for Research in Operative Medicine (IFOM). The evaluation of evidence was based on the system developed by the Scottish Intercollegiate Guidelines Network (SIGN). A multi-part nominal group process moderated by the AWMF was used to compile this S3-level guideline. Recommendations Recommendations on consultations, indications and the process of performing a caesarean section as well as the care provided to the mother and neonate were drawn up.

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.

Midwives' perceptions of women's preferences related to midwifery care in Germany: A focus group study.

OBJECTIVE: To explore how midwives perceive patient preferences related to midwifery care in Germany. DESIGN: This qualitative study, which was part of a larger study, used a hermeneutic-interpretive approach and involved focus group interviews with midwives. Data collection and analysis were done in a conjoined fashion between April 2015 and September 2016. SETTING: Four focus group interviews were conducted in four different federal states of Germany. PARTICIPANTS: The sample of 20 qualified midwives was heterogeneous with regards to age, educational level, professional experience, type of midwifery care provided, and setting (employed, caseload, education) in which they provided services. FINDINGS: Three main themes were identified: Strengths and limitations of midwives' present professional profile (midwives' area of responsibility, range of services, and competency); lack of midwives and midwifery services; women's experiences of conflict in interprofessional care. Each main theme is broken down into several aspects of content. Many women are not aware of the scope of professional knowledge and expertise of midwives. Moreover, the poor delineation of midwives' and obstetricians' areas of competency in Germany's hospitals seems to be disadvantageous for the women. Midwives feel that due to context implications they cannot live up to the quality of midwifery care they aspire to. Lack of midwives results in midwives being overwhelmed, women underserved, and both disappointed. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: On the one hand, new models of midwifery/maternity care need to be developed to solve some of the existing problems; on the other hand, new forms of interprofessional cooperation and management of transition of care points are required. Overall it is important that changes are implemented in such a way that women are enabled, and welcome, to clearly state their preferences for midwifery and maternity care. Particularly in Germany, tertiary education of midwives is needed to broaden their expertise and place them on an equal footing with obstetricians.

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.

Experiences and wishes of women regarding systemic aspects of midwifery care in Germany: a qualitative study with focus groups.

BACKGROUND: Knowledge of pregnant women's and mothers' viewpoints on midwifery care is crucial for its appropriate delivery and research. In Germany, comprehensive research to more fully understand women's needs in pregnancy, labour, birth and the postpartum period until weaning is lacking. International studies provide some knowledge of women's expectations, their choices, and subjective criteria indicating good midwifery care. METHODS: This study explores pregnant women's and mothers' experiences, needs and wishes regarding systemic aspects of midwifery care (access, availability, choices, model of midwifery care; maternity care in the healthcare system). 50 women participated in 10 focus groups in 5 states of Germany. The groups were heterogeneous with regard to age, parity, model of maternity care used, and rating of satisfaction. Women with limited educational years (n = 9) were personally contacted by midwives and reached by social media. Also, mothers living in a mother-child home (n = 6) or attending a peer group for grieving parents (n = 5) were included. The digitally documented focus groups were systematically analysed in an itinerary hermeneutic manner. RESULTS: Three themes were identified: (a) Knowledge or lack of awareness of midwifery care, (b) availability of and access to midwives, and (c) midwifery care in the healthcare system. Theme (a) entails the scope of midwifery care and the midwife's competence, but also a lack of information, inconsistent counselling, and difficulty identifying midwives. Theme (b) encompasses aspects such as the availability, accessibility and selection of a midwife, the effort involved in looking for a midwife, the challenge of transition points, and family midwives. Theme (c) relates interprofessional cooperation, gaps/inadequacies of care during latency phase, alternative models of care, and the importance of family and peer groups for women. CONCLUSIONS: Midwifery care and research in Germany must address the issue of imparting relevant information about midwifery services. Interprofessional cooperation and management of transition points ought to be improved in the interests of the women concerned. Moreover, the quality of antenatal classes, support during latency phase, and intrapartum care in hospitals need to be addressed. Lastly, the special needs of vulnerable women in midwifery care must become a major focus in Germany.

[Analysis of potential for research on giving birth in an upright position in German hospitals]. / Potenzialanalyse zur aufrechten Gebärhaltung bei physiologischen Geburten in deutschen Kreißsälen.

HEALTH PROBLEM: In German hospitals, three quarters of all low-risk pregnant women give birth in the supine position, despite the fact that German, British and WHO guidelines do not recommend a supine birthing position which is associated with a higher risk to the health of both mother and fetus. CORPUS OF EVIDENCE: Based on 22 RCTs with 7,280 participants, a systematic Cochrane review (Gupta et al., 2012) revealed that an upright position - compared with a supine or lithotomy position - (1) has a positive impact on fetal heart rate patterns, (2) reduces the requirement for analgesic or anaesthetic medications in the second stage of labour, and (3) results in fewer episiotomies and (4) fewer instrumental deliveries. There is a lack of evidence regarding perceived maternal autonomy, self-efficacy and anxiety when giving birth. Furthermore, evidence on long-term effects is absent. Some studies indicate that the choice of an upright birthing position might be boosted by a supporting physical and social environment and by specially trained midwives. IMPLICATION FOR RESEARCH: There is a need for a feasibility study and a subsequent cluster RCT in the German healthcare context in order to investigate the effects of the upright posture for birthing on perceived maternal autonomy, self-efficacy and anxiety, on the reduction of perinatal complications and on long-term complaints. The complex experimental intervention consists of (1) evidence-based and user-friendly information for women and their partners, (2) facilitating the choice for an upright labour position by special training for midwives and (3) providing a supportive physical and social environment. Within the first study phase, the exploration of feasibility in terms of access to the target group and acceptance of the intervention by pregnant women, their partners and midwives is recommended. Thereby, the implementation of guidelines for upright labour and birth, the documentation and collection of outcome and cost data could be evaluated. Non-German instruments for measuring benefits, harms and long-term effects could be adapted to and validated for the German context.