Association of personal and systemic factors on intrapartum risk perception and obstetric intervention rates: a cross-sectional study.

BACKGROUND: Risk perception is fundamental to decision-making; therefore its exploration is essential to gaining a comprehensive understanding of the decision-making process for peripartum interventions. The aim of this study was to investigate associations between personal and systemic factors of the work setting and the risk perception of obstetric healthcare professionals, and in turn how this might influence decisions regarding obstetric interventions. METHODS: Case vignettes were used to measure risk perception. A quantitative cross-sectional online survey was performed within an exploratory sequential mixed-methods design, and an intervention readiness score created. Associations were calculated using location and dispersion measures, t-tests and correlations in addition to multiple linear regression. RESULTS: Risk perception, as measured by the risk assessment score, was significantly lower (average 0.8 points) for midwives than for obstetricians (95%-CI [-0.673; -0.317], p < .001). Statistically significant correlations were found for: years of experience and annual number of births in the current workplace, but this was not clinically relevant; hours worked, with the groups of participants working ≥ 30,5 h showing a statistically significant higher risk perception than participants working 20,5-30 h (p = .005); and level of care of the current workplace, with the groups of participants working in a birth clinic (Level IV) showing a statistically significant lower risk perception than participants working in Level I hospital (highly specialised obstetric and neonatal care; p = .016). The option of midwife-led birthing care showed no correlation with risk perception. The survey identified that risk perception, occupation, years in the profession and number of hours worked (i.e. full or part time) represent significant influences on obstetric healthcare professionals' willingness to intervene. CONCLUSIONS: The results of the survey give rise to the hypothesis that the personal and systemic factors of professional qualification, occupation, number of hours worked and level of acuity of the workplace are related to the risk perception of obstetric healthcare professionals. In turn, risk perception itself made a significant contribution to explaining differences in willingness to intervene, suggesting that it influences obstetricians' and midwives' decision-making. Overall, however, the correlations were weak and should be interpreted cautiously. The significant variations in the use of interventions must be addressed in order to provide the highest quality and best possible care for childbearing women and their families. To this end, developing strategies to improve interdisciplinary relationships and collaboration is of great importance. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017172 (18.06.2019).

The impact of severe perinatal events on maternity care providers: a scoping review.

BACKGROUND: Severe events during the perinatal period can be experienced as traumatic by pregnant women, their partners or others who are closely involved. This includes maternity care providers who can be affected by being involved in or observing these events. This may have an impact on their personal well-being and professional practice, influencing quality of care. The aim of this study is to map research investigating the impact of severe events during the perinatal period on maternity care providers, and how these experiences affect their well-being and professional practice. METHOD: A scoping review following the manual of the Joanna Briggs Institute was undertaken. The electronic bibliographic databases included PubMed/MEDLINE, CINAHL, PsycINFO, PsycARTICLES, SocINDEX, Cochrane, Scopus, Web of Science and databases for grey literature. Records passing the two-stage screening process were assessed, and their reference lists hand searched. We included primary research papers that presented data from maternity care professionals on the impact of severe perinatal traumatic events. A descriptive content analysis and synthesis was undertaken. RESULTS: Following a detailed systematic search and screening of 1,611 records, 57 papers were included in the scoping review. Results of the analysis identified four categories, which highlighted the impact of traumatic perinatal events on maternity care providers, mainly midwives, obstetricians and nurses: Traumatic events, Impact of traumatic events on care providers, Changes in care providers' practice and Support for care providers; each including several subcategories. CONCLUSION: The impact of traumatic perinatal events on maternity care providers ranged from severe negative responses where care providers moved position or resigned from their employment in maternity care, to responses where they felt they became a better clinician. However, a substantial number appeared to be negatively affected by traumatic events without getting adequate support. Given the shortage of maternity staff and the importance of a sustainable workforce for effective maternity care, the impact of traumatic perinatal events requires serious consideration in maintaining their wellbeing and positive engagement when conducting their profession. Future research should explore which maternity care providers are mostly at risk for the impact of traumatic events and which interventions can contribute to prevention.

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.

Intrapartum risk perception-A qualitative exploration of factors affecting the risk perception of midwives and obstetricians in the clinical setting.

OBJECTIVE: to gain an in-depth view of the specific risk perception of midwives and obstetricians, in order to achieve a deeper understanding of the situations which midwives and obstetricians perceive as risky and of the factors affecting their risk perception. DESIGN: a qualitative approach using focus group discussions was used as part of the first strand within a sequential explorative mixed methods project. PARTICIPANTS: 24 midwives and obstetricians providing labour care in the clinical setting ANALYSIS: according to qualitative content analysis. FINDINGS: both external and internal factors were identified which potentially influence the risk perception of midwives and obstetricians: (i) the individual perception of the obstetric health professional, (ii) the dyad of obstetric health professional & woman, (iii) being part of a team and (iv) being part of an institution. While risk definitions/classifications and obstetric risk factors were less common topics, structural and organisational factors, such as lack of staff and excessive workload, dominated the discussions about risky situations in the delivery room. KEY CONCLUSION: Obstetric health professionals' risk perception is multifactorial and risky situations in the delivery room can be described as a complex construct of various factors. The results suggest that there are different forms of risk perception and different factors which are perceived as risky. IMPLICATIONS FOR PRACTICE: Reflection on one's own role and actions should be included in the training of obstetric professionals and also be maintained in everyday professional life.

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.

A questionnaire to measure the quality of midwifery care in the postpartum period from women's point of view: development and psychometric testing of MMAYpostpartum.

BACKGROUND: Home postpartum care is a major part of midwifery care in Germany. The user perspective plays an increasingly important role in the evaluation of health services, but there is a lack of valid and theoretically based measuring instruments, especially in midwifery care. The aim of this study was to develop and validate an instrument for measuring quality of midwifery care in the postpartum period from the perspective of women. METHODS: The following steps were taken to achieve this: (1) definition of the goals of midwifery work; (2) literature-based item development; (3) item selection based on a pre-test (n = 16); (4) item reduction and investigation of factor structure by means of explorative factor analysis (EFA; n = 133);(5) second EFA (n = 741) and confirmatory factor analysis (CFA; n = 744) based on a split representative sample survey; (6) hypothesis-based testing of correlations to sociodemographic characteristics of women and to characteristics of care. RESULTS: Measurement of Midwifery quality postpartum (MMAYpostpartum) consists of three scales with a total of 17 items which were found to have acceptable internal consistency: Personal Control (Cronbach's alpha = .80), Trusting Relationship (Cronbach's alpha = .87) and Orientation and Security (Cronbach's alpha = .78). CFA verified and confirmed three factors: CFI = .928, TLI = .914, RMSEA = 0.073. CONCLUSION: MMAYpostpartum is a predominantly valid, reliable short tool for evaluating the quality of midwifery care postpartum. It can be used to evaluate midwifery care, to compare different care models and in intervention research. It thus supports the orientation of midwives' work towards the needs of women and their families.

Risk Perception of Health Professionals in Intrapartum Care Decisions: Protocol for a Mixed Methods Study.

BACKGROUND: Risk perception plays an important role in decision-making processes. Differences in obstetric intervention rates suggest that, in addition to medical indications, the risk perception of obstetric health professionals might have a major influence on their decision-making process during childbirth. Although studies have investigated whether risk perception affects the role of midwifery or influences decision making during childbirth, little is known about what obstetric health professionals actually perceive as risk or risky situations and whether different risk perceptions lead to more interventions during intrapartum care. OBJECTIVE: The objective of this study is to understand the association of risk perception and the decision-making processes of obstetric health professionals (midwives and obstetricians) in Germany during intrapartum care. The study has 3 specific aims: (1) gain insight into what obstetric health professionals perceive as risk in the German clinical setting, (2) assess the extent to which personal and systemic factors have an impact on obstetric health professionals' risk perception, and (3) investigate whether different perceptions of risk are associated with different decisions being made by obstetric health professionals. METHODS: This is an exploratory sequential mixed methods study with 2 phases, a qualitative followed by a quantitative phase. In the first phase, qualitative data are collected and analyzed by conducting focus group discussions and applying qualitative content analysis to address aim 1. In the second phase, for aims 2 and 3 and to help explain the qualitative results, quantitative data are collected and analyzed by conducting an observational study using case vignettes within a survey constructed on the basis of the qualitative results. RESULTS: Enrollment in the first (qualitative) phase began in July 2019, and data collection and analysis have been completed. The second (quantitative) phase is currently planned, and data collection is expected to start in December 2020. First results of the qualitative phase are expected to be submitted for publication in 2020, with completion of the second phase scheduled for 2021. CONCLUSIONS: This mixed methods study will examine the perception of risk and its association with the decision-making processes of obstetric health professionals during their care of women in childbirth. The rationale for this approach is that the qualitative data and their analysis explore participants' views in more depth, while the quantitative data will help to provide and explore a general understanding of the research problem. The results are expected to be relevant to health care professionals, policymakers, and educational institutions in order to minimize underuse, overuse, and misuse of interventions during intrapartum care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017172; https://tinyurl.com/y2zoowkx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21443.

A theory of the aims and objectives of midwifery practice: A theory synthesis.

INTRODUCTION: Every discipline has a dichotomous objective by which it recognizes whether its work has been successful (Vogd, 2011). For midwifery care, no objective has been set in this way so far. This also has implications for measuring quality, because quality of care is only measurable if objectives have been identified. This paper aims to contribute to theory formation in midwifery science by analysing existing concepts and theories and preferences of women to midwifery care to answer the question of the dichotomous objective of midwifery. METHOD AND FINDINGS: The method of theory synthesis (Walker and Avant, 2011) was used to analyse existing theories and concepts of midwifery care and literature-based preferences of women to midwifery care and synthesize them with regard to the objectives of midwifery care. The synthesis took place in the form of a means-end chain to extract the dichotomous target of midwifery care. In this way, the objectives of midwifery could be compared and linked from both the scientific and from women's perspective. The resulting means-end chain model of the process of midwifery describes the aims and objectives of midwifery from the point of view of women on three levels. DISCUSSION: The hierarchical model of the process of midwifery presented here is a first attempt to illustrate the aims and objectives of midwifery practice in a means-end chain model in order to facilitate discussion on the topic and to make the quality of midwifery care measurable. Measurement is a first step towards improving quality of midwifery care and thereby improving women's reproductive capabilities.

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.

Temporal trends in fetal mortality at and beyond term and induction of labor in Germany 2005-2012: data from German routine perinatal monitoring.

PURPOSE: While a variety of factors may play a role in fetal and neonatal deaths, postmaturity as a cause of stillbirth remains a topic of debate. It still is unclear, whether induction of labor at a particular gestational age may prevent fetal deaths. METHODS: A multidisciplinary working group was granted access to the most recent set of relevant German routine perinatal data, comprising all 5,291,011 hospital births from 2005 to 2012. We analyzed correlations in rates of induction of labor (IOL), perinatal mortality (in particular stillbirths) at different gestational ages, and fetal morbidity. Correlations were tested with Pearson's product-moment analysis (α = 5 %). All computations were performed with SPSS version 22. RESULTS: Induction rates rose significantly from 16.5 to 21.9 % (r = 0.98; p < 0.001). There were no significant changes in stillbirth rates (0.28-0.35 per 100 births; r = 0.045; p = 0.806). Stillbirth rates 2009-2012 remained stable in all gestational age groups irrespective of induction. Fetal morbidity (one or more ICD-10 codes) rose significantly during 2005-2012. This was true for both children with (from 33 to 37 %, r = 0.784, p < 0.001) and without (from 25 to 31 %, (r = 0.920, p < 0.001) IOL. CONCLUSIONS: An increase in IOL at term is not associated with a decline in perinatal mortality. Perinatal morbidity increased with and without induction of labor.