Links between patient safety and fear of childbirth—A meta‐study of qualitative research

Abstract Aim To conduct a meta‐study of qualitative empirical research to explore the links between patient safety and fear of childbirth in the maternity care context. The review questions were: How are patient safety and fear of childbirth described? and What are the links between patient safety and fear of childbirth in the maternity care context? Design Meta‐study. Data sources The CINAHL, Cochrane, PubMed, Webb of Science, Proquest and Medline (Ovid) electronic databases were searched for articles published between June 2000‐June 2016. Review methods A meta‐study of qualitative research with a thematic analysis followed by a synthesis. Results Four descriptive themes emerged: “Physical risks associated with giving birth vaginally”; “Control and safety issues”; “Preventing psychological maternal trauma and optimizing foetal well‐being”; and “Fear of the transition to motherhood due to lack of confidence”. The two overarching analytical themes: “Opting for safety” and “An insecure environment breeds fear of childbirth”, represent a deeper understanding and constitute the synthesis of the links between patient safety and fear of childbirth. This meta‐study indicates the need for increased commitment to safe care and professional support to reduce risks and prevent unnecessary harm in maternity care.


| BACKG ROU N D
PS challenges concerning caesarean sections (CS) have been identified (WHO, 2015). While CS can be lifesaving for both the mother and unborn child, it is also used in situations where neither the mother nor the unborn child is at greater risk of complications than the rest of the peripartum population (Khunpradit et al., 2011). Reported CS rates vary, especially between developed and developing countries.
In England, Scotland, Norway, Finland, Sweden and Denmark CS rates have risen from around 4% to 5% in 1970to 20% to 22% in 2001 (2001); Macfarlane et al., 2000). In low and middle income countries, CS rates have also increased significantly during this period. Rates above 15% are reported in more than half of Latin American countries (Belizán, 1999).
The overall CS rate in nine Asian countries was 27.3%. China had the highest CS rate, followed by Vietnam and Thailand (Lumbiganon et al., 2010). Betrán et al. (2016) conclude that the use of CS has increased to unprecedented levels. In 1985, the WHO issued a consensus statement suggesting that there were unlikely to be any additional health benefits associated with a CS rate above 10%-15%, while in 2015 the same organization described the increasing use of CS as a global health challenge and recommended vaginal birth as the first choice for healthy women (WHO, 2015). The main reasons for this recommendation are overuse of health resources and the risks involved in CS such as maternal infections, haemorrhage, the need for transfusion, injury to other organs, anaesthetic complications and psychological complications (International Cesarean Awareness Network (ICAN), 2002). Surveys conducted in Canada, the UK, Australia and Sweden have identified reasons for the increased number of CSs such as having undergone a previous CS, a negative birth experience and/or fear of giving birth (Edwards & Davies, 2001;Karlström et al., 2010;Pakenham, Chamberlain, & Smith, 2006;Waldenström, Hildingsson, & Ryding, 2006;Weaver, Statham, & Richards, 2007). The predominant reason for requesting a CS is FOC (Nieminen, Stephansson, & Ryding, 2009).
There has been a long-standing focus on FOC in maternity care, but as it has been defined in various ways the literature on the subject is inconsistent (Zar, Wijma, & Wijma, 2002). The prevalence of FOC seems to depend on the definition of the condition, the measurement tools used and the cultural context. Previous population-based studies in Scandinavia have found that FOC complicates 7.6%-17.8% of pregnancies (Laursen, Hedegaard, & Johansen, 2008;Nilsson, Lundgren, Karlström, & Hildinsson, 2012). The reasons for fear differ. Research on birth experiences and their association with fear has mostly focused on obstetric factors such as emergency CS, vacuum extraction and pain during labour (Størksen, Garthus-Niegel, Vangen, & Eberhard-Gran, 2008). Women's characteristics, such as anxiety, depression, low self-esteem and lack of social support, have also been associated with FOC (Saisto & Halmesmäki, 2003). A connection has been found between FOC and a history of sexual assault, abuse and violence (Lukasse, Vangen, Øian, & Schei, 2010). Størksen et al. (2008) found that while obstetric complications do contribute to FOC, the association with previous subjective birth experiences is even greater and Walsh (2002) stated that the causes of FOC should be sought in maternity care rather than in the women's characteristics. Lyberg and Severinsson (2010) revealed that negative subjective birth experiences were often due to lack of a relationship with the midwife and other staff members, not being included in decision-making, not having ownership of the birth and loss of dignity.
Subjective birth experiences are crucial from a PS perspective, while the objective characteristics of each birth and the woman's personality are less important. In the present study, the focus on PS and FOC also includes the first postnatal week as it is regarded as part of maternity birth services and during this period a sense of security is important for women's experiences of the transition to motherhood (Persson & Dykes, 2002). New mothers' physical and emotional experiences influence their well-being (Waldenström & Rudman, 2008). Challenges concerning PS in the provision of quality maternity and postnatal care have been identified (Lyndon et al., 2015;Severinsson et al., 2015). Healthcare system users' experiences should be fundamental when assessing the quality of care (Berwick, 2002) and healthcare providers should be aware of what women need and want for a safe childbirth, as FOC is a problem for a significant number of women.

| Aim
The aim was to conduct a meta-study of qualitative empirical research to explore the links between PS and FOC in the maternity care context. The review questions were: How are PS and FOC described and What are the links between PS and FOC in the maternity care context?

| Design
A meta-study approach inspired by Paterson, Thorne, Canam, and Jillings (2001) was employed. The analysis procedure involves three steps that should be undertaken prior to the synthesis. These are meta-data analysis (the analysis of the findings) in a particular area; meta-method (the analysis of methods) and meta-theory (the analysis of the theory of the underlying structures on which the research is grounded) (Paterson et al., 2001, p. 10;Barnett-Page & Thomas, 2009). The first step was to obtain an overview of the findings and analyse the substance of PS and FOC. The second step involved determining the methodological congruence of each article. We evaluated the sampling, data collection and analysis, as well as the data interpretation, rigor and auditability. In the third step, the links between PS and FOC were conceptualized. The three steps resulted in a synthesis that constitutes the meta-study (Paterson et al., 2001, p. 13).
Thus, a meta-study is an interpretative qualitative approach to the phenomena of PS and FOC. The problems associated with understanding PS and FOC will be illuminated in the discussion.

| Eligible articles
The eligibility criteria for selecting articles were qualitative empirical studies focusing on the links between PS and FOC.

| Search outcome
One hundred and ninety-seven articles were identified before the elimination of duplicates. The selected articles were sorted by design, characteristics and location of the authors. During this process, three additional articles were identified through two manual searches, resulting in a total of nine empirical articles for analysis ( Figure 1).

| Critical appraisal of the included articles
The Joanna Briggs Institute (JBI), 2015) Critical Appraisal Tool for qualitative research (Lockwood, Munn, & Porritt, 2015) was used for quality assessment of the methodology. There are ten criteria for qualitative research: congruity between the stated philosophi-
Data extraction started by carefully reading and reflecting together on the content of the included studies to achieve a more comprehensive understanding and higher level of abstraction, the three stages presented by Thomas and Harden (2008, p.

| RE SULTS
In total, nine articles were included and synthesized. Initially, four descriptive themes emerged in the analysis: (a) Physical risks associated with giving birth vaginally; (b) Control and safety issues; (c) Preventing psychological maternal trauma and optimizing foetal well-being and (d) Fear of the transition to motherhood due to lack of confidence. In addition, two overarching analytical themes: "Opting for Safety" and "An insecure environment breeds fear of childbirth" emerged. Table 1 presents the included articles and their contribution to the results. In the following, the four themes and descriptions of the links between PS and FOC are presented.  . One important reason for women to request a CS was concern about physical injury as they underestimated the ability of their female body. They were also afraid of experiencing pain and undergoing specific interventions and procedures during labour Nilsson & Lundgren, 2009 Contributes to the following themes: 1) Risks associated with giving birth vaginally, 2) Control and safety issues 3) Preventing psychological maternal trauma and optimizing foetal well-being 4) Fear of the transition to motherhood due to lack of confidence. VBAC: vaginal birth after caesarean section; VBB: vaginal breech birth.

| Physical risks associated with giving birth vaginally
TA B L E 1 (Continued) of the challenges. The attitude that the birth was unimportant and primarily about "getting" a baby was reported .
When women placed themselves in the hands of a surgical team for a CS, they relied on the professionals' high level of expertise to safeguard themselves and their child. A CS meant that the risk of a shortage of midwives to monitor the birth process and support the women was avoided (Larkin et al., 2012).

| Control and safety issues
This theme focuses on control. The women considered that a CS was safe, calm and predictable . Larkin et al. (2012) reported that women's perceptions of control encompass a range of issues and contexts. The authors highlight information and the re- reported different PS management models and the need for continuity of care as the latter ensure a sense of safety and control.

| Preventing psychological maternal trauma and optimizing foetal well-being
This theme concerns maternal psychological trauma in addition to the well-being of the mother and unborn child. Negative experiences with staff were reported by Nilsson and Lundgren (2009). The sense of not being present in the delivery room, not being allowed to actively participate in the birth and an incomplete childbirth experience remained etched in the women's minds, giving rise to fear (Nilsson et al., 2010).
Although midwives played an important role, it was suggested that they disempowered women and failed to promote positive experiences, leaving some women feeling alone and unsupported (Larkin et al., 2012). Two of the articles mention women's fear of maternal trauma due to diminished trust (Nilsson & Lundgren, 2009;Nilsson et al., 2010). A feeling of danger, being trapped and loneliness (Nilsson & Lundgren, 2009;Nilsson et al., 2010) as well as stress and fear (Petrovska et al., 2017) was reported.

| Fear of the transition to motherhood due to lack of confidence
This theme focuses on the transition, a common theme in all nine articles. Most of the articles provide evidence of fear in relation to being unable to take responsibility for the new-born baby in unpredictable situations , breastfeeding (Forster et al., 2008), lack of safety due to information getting lost during the handover and not being involved in decision-making (de Jonge et al., 2014). It also includes the need to be encountered as an individual, receive relevant information, be prepared for the time after the birth, have someone to turn to, know who to ask and have planned followup of the health of the mother and baby after discharge (Persson, Fridlund, Kvist, & Dykes, 2010).

| Links between PS and FOC
Two overarching analytical themes represent a final synthesis of our understanding of the links between PS and FOC. The themes are intertwined and represent areas of inadequate PS practice on system, organizational and individual healthcare professional levels. The first, Opting for safety, indicates that women's knowledge of the risks of vaginal birth ensures that they take responsibility for themselves and the baby. PS practice is a guarantee of safe care and facilitates information about and an awareness of the potential risks of childbirth, as well as the responsibility inherent in becoming a mother. In addition, lack of control was reported Foster et al., 2008;Goberna-Tricas et al., 2011;de Jonge et al., 2014;Larkin et al., 2012;Nilsson & Lundgren, 2009;Nilsson et al., 2010;Person et al., 2010;Petrovska et al., 2017). Enhanced power, control and woman-centred care are essential for a feeling of safety. The requests for a CS can be seen as a result of lack of communication with the midwife or lack of continuity with a trusted midwife. Decisions about the mode of birth are complex and our interpretation is that women try to minimize the risk by opting for safety as opposed to insecurity (de Jonge et al., 2014;Fenwick et al., 2010;Larkin et al., 2012;Nilsson & Lundgren, 2009;Nilsson et al., 2010;Petrovska et al., 2017). In addition, fear of the transition to motherhood was reported, implying that new mothers wanted to learn how to care for the baby (de Jonge et al., 2014;Fenwick et al., 2010;Forster et al., 2008;Nilsson & Lundgren, 2009;Nilsson et al., 2010;Persson et al., 2010;Petrovska et al., 2017).
The second analytical theme: "An insecure environment breeds fear of childbirth", emphasizes the importance of understanding FOC. Like the previous analytical theme, it includes safety as well as lack of control in relation to the transition to motherhood due to lack of confidence Forster et al., 2008;de Jonge et al., 2014;Larkin et al., 2012;Nilsson et al., 2010;Person et al., 2010). It can also be interpreted as a fear of complications, thus is linked to PS Nilsson & Lundgren, 2009).
Professional ability to detect when patients are at risk of harm is a prerequisite for managing unsafe situations, adverse events or near misses (Goberna-Tricas et al., 2011;Larkin et al., 2012;Nilsson et al., 2010). One interpretation is that stressful situations may give rise to increased fear if the patient lacks trust in the healthcare professional (Forster et al., 2008;Goberna-Tricas et al., 2011;Nilsson & Lundgren, 2009;Petrovska et al., 2017). Communication and teamwork problems are well known and a great challenge to PS.

| D ISCUSS I ON
The aim was to conduct a meta-study of qualitative empirical research to explore the links between PS and FOC in the maternity care context. Four descriptive themes and two overarching analytical themes; "Opting for safety" and "An insecure environment breeds fear of childbirth", were identified, leading to an understanding of PS and FOC.
The two analytical themes can guide the continuous development of PS in maternity care. "Opting for safety" reveals the women's need to feel safe when giving birth and is, according to the studies included in this review, a challenge for maternity care. The relationship between FOC and previous birth experiences is described by Størksen et al. (2008) as well as Saisto and Halmesmäki (2003). Most women with FOC have negative birth experiences from a previous pregnancy, while many also have a "hereditary" fear due to stories told them by their mothers or friends (Sjögren & Thomassen, 1997 were common themes in the included studies. In many countries, maternity care has been centralized to a few busy hospitals, leading to a routinized care culture that fails to fulfil individual human needs (Berg, Ólafsdottir, & Lundgren, 2012). An example was found in a study from Sweden, where parents were: "waiting for permission to enter the labour ward world", implying that parents made an effort to determine the appropriate time at which to arrive to avoid being refused entry for coming too early (Nyman, Downe, & Berg, 2011). It is likely that a positive first meeting and a welcoming atmosphere is of the utmost importance for the whole birth process. In our synthesis, FOC can be interpreted as a fear of surrendering. Although some women are empowered by their childbirth experience, others report feeling anxious, lonely and unsupported during and after the birth (Larkin et al., 2012). Midwives in modern institutional care are obliged to attend to more than one woman at a time, which could prevent them from being present in the delivery room to fulfil the women's need to be safeguarded (Larkin et al., 2012;Nilsson et al., 2010). This is in contrast to the midwifery model of woman-centred childbirth care presented by Berg et al. (2012), where the importance of a reciprocal relationship between the midwife and the labouring woman and her partner is highlighted.
A reciprocal relationship involves presence, affirmation, availability and participation. A midwife who is physically and mentally present is viewed as the essence of the encounter (Berg et al., 2012). In addition, Hunter, Lundgren, Ólafsdottir, and Kirkham (2008) claim that communication skills are the most important characteristic of a good midwife. One possible explanation for the increase in CS is that women choose this mode of childbirth when they lack trust in their midwife because they consider CS safer, more predictable and that it gives them a sense of control. Larkin et al. (2012) found that the continuous development of relationships with professionals either enhanced or detracted from the feeling of control. The length of postnatal hospital care has decreased in Scandinavian and many other countries in recent years. Researchers and policymakers are increasingly concerned about the low levels of satisfaction with hospital care following birth and have recommend that providers should give this area higher priority (McLachlan, Forester, Yelland, Rayner, & Lumley, 2008;Rudman & Waldenström, 2007). Brown, Small, Davis, Faber, and Krastev (2002) identified the most negative factors as the sensitivity of caregivers; the extent to which anxieties and concerns were taken seriously; how rushed caregivers seemed; the helpfulness of advice and support and whether help and support were offered at all. In our study, the transition to motherhood was found to be a complex process and women wanted to learn to care for their baby. Another concern in the postnatal period is raised by Munro, Janssen, Corbett, Bansback, and Kornelsen (2017), who reported that women start to reflect on future pregnancies and mode of delivery immediately after birth. In particular, women who regard the birth as unsafe and experienced a loss of control will construct birth as a frightening event. Such women need support to process the experience shortly after the birth, which is in line with Takegata  incidents and near-misses still occur, thus safety concerns must be acknowledged to prevent harm (Martijn et al., 2013). A PS culture is characterized by open communication and a willingness to learn from adverse events . This contrasts with the study by Lyndon et al. (2015) on 3,282 physicians, midwives and registered nurses who care for women during labour and birth, where 90% of the respondents reported witnessing shortcuts, lack of competence, disrespect or performance problems in the preceding year. Although concerned about PS, they were not always willing to speak up and resolve these issues, the reason for which was the profound disagreements between professionals and providers about the resources and support necessary to deliver safe care.
A sense of resignation regarding professionals' ability to change the situation was also found. These results indicate the need for healthcare organizations to create an environment where a safety culture is an explicit goal driven by leadership, as recommended by Kohn et al. (2000). The organization is responsible for providing PS and best practice guidelines. Although it is necessary to achieve an optimal care outcome for each woman, this does not necessarily correspond with healthcare system models. Overuse of ultrasound in addition to excessive monitoring of the unborn babies' heart rate and women's contractions are common. Maternity wards are designed to function effectively and equipped for medical interventions, which can lead to stress and feelings of insecurity for the woman and her partner. In her study, Nilsson (2014) found that midwives choose to follow medical routines rather than taking the women's needs into account, which gave the women a feeling of not being important and involved in the birth process. Another aspect of modern birth units at many hospitals is the installation of computer stations in each birth room. Foureur et al. (2010) found that the computers constitute an obstacle to effective, collaborative communication as the documentation routines are rigorous and distracting, resulting in less attention for the women. In turn, women can perceive the routines as uncaring, leading to feelings of being unseen and unprotected, which can result in a lack of confidence. On the other hand, the present findings reveal that many women also feel safe as a result of the high standard of technical equipment in delivery rooms. Nevertheless, Nilsson (2014) concludes that the delivery room is a place that creates FOC. As The lack of confidence in maternity care delivery should be explored (WHO, 2015), which calls for leadership, innovation and integration of fundamental values, principles and goals to ensure safe, highly reliable individual practice (Carter et al., 2010). Woman-centred care, continuity of care, teamwork and communication should be regarded as key components of an enhanced PS culture (Kohn et al., 2000) that may reduce feelings of insecurity and support each individual woman when giving birth.

| Limitations
This meta-study contributes to an increased understanding of the links between PS and FOC. However, some limitations should be discussed. To determine the transferability of a study, the range of empirical variation in the sample must be taken into consideration.
In this study, the sample included women of different status and age from five countries. Although the number of studies included (n = 9) was fairly limited, it was considered appropriate as the findings from the analysis exceeded the results from the individual studies, thus enabling a synthesis. However, it is likely that PS and FOC may be understood differently in non-Western cultures.
PS may be commonly regarded as more "risk focused" by medical staff and mothers in countries with high CS rates, while the PS process including shared decision-making may differ in Asian societies where mothers tend to ask professionals to make a decision on their behalf. Furthermore, as healthcare professionals' working environment is culturally and socially sensitive, more evidence from other regions is required to make an optimal assessment of the cultural implications.
Credibility depends on the degree to which the study has explored the phenomenon it was intended to explore and if the methods used were appropriate. In this study, the data collection process and data results have been clearly described and are presented in Table 1. Although we conducted a broad literature search guided by an experienced librarian, we are aware that our choice of search terms and inclusion criteria may have affected the credibility.
The use of a critical assessment tool guided by a checklist deemed suitable for our purpose enabled a thorough overall appraisal of the articles and whether the methods employed were appropriate. All researchers read the papers and agreed on the themes, which involved collaborative work throughout the process. However, when conducting a meta-study, data are decontextualized and removed from their original context, implying the risk that important findings in the primary research may be overlooked.

| CON CLUS ION
If the prerequisites for PS are lacking, it is likely that women will have little trust in maternity care. When women do not experience safety, they are afraid of giving birth and consider CS the preferred mode of delivery, which calls for attention. Feeling insecure in the first postnatal week also has a negative influence on the transition to motherhood. A PS culture is related to the systems and process of care. To achieve greater trust, we recommend educational interventions about the nature of PS to prevent incidents and FOC. This meta-study indicates the need for increased commitment to safe care and professional support in order to reduce risks and prevent unnecessary harm in maternity care.

ACK N OWLED G EM ENTS
The authors would like to thank Monique Federsel for proofreading the English language and the specialized librarian at the University College of Southeast Norway for valuable help with the electronic search for articles.

CO N FLI C T S O F I NTE R E S T
All authors declare that there are no conflicts of interest with regard to this study.
Q1Is there congruity between the stated philosophical perspective and the research methodology? Q2Is there congruity between the research methodology and the research question or objectives? Q3 Is there congruity between the research methodology and the methods used to collect data? Q4 Is there congruity between the research methodology and the representation and analysis of data? Q5 Is there congruity between the research methodology and the interpretation of results? Q6 Is there a statement locating the researcher culturally or theoretically? Q7 Is the influence of the researcher on the research, and vice-versa, addressed? Q8 Are participants, and their voices, adequately represented? Q9 Is the research ethical according to current criteria or, for recent studies, and is there evidence of ethical approval by an appropriate body? Q10 Do the conclusions drawn in the research report flow from the analysis, or interpretation, of the data?