Informed decision-making enables women to make choices that reflect their own beliefs and preferences and is at the heart of provision of woman-centred care. There is evidence that women want information and choices in their care and there are well-established links between perceived control and improved emotional outcomes (Churchill and Benbow, 2000; Kirkham, 2004).
Around one in six pregnant women in the UK have an RhD-negative blood type, and are offered anti-D immunoglobulin (Ig) to prevent sensitisation with anti-D antibodies (maternal sensitisation). To be effective, anti-D Ig should be administered within 72 hours of a potentially sensitising event (such as antepartum haemorrhage) or the birth of an RhD-positive baby. Routine antenatal anti-D Ig prophylaxis (RAADP) has been recommended by the National Institute for Health and Care Excellence (NICE, 2008) since 2002 and is now widely offered during pregnancy in order to prevent silent maternal sensitisation (occurring without outward signs) during the third trimester.
Anti-D Ig is a human blood product and, as such, carries a risk of transmission of viral infection. It has been estimated that the risk of transmission of known viruses for which there are screening tests is around 1 in 10 000 million doses (Bio Products Laboratory, 2012). However, the risk from viruses for which there are no current screening tests, and the potential for transmission of as yet unknown viruses, is difficult to determine (Urbaniak, 1998). Anti-D Ig may also cause hypersensitivity (nausea, dizziness, headaches) and anaphylaxis, but these are rare (Rutkowski and Nasser, 2014).
The most serious consequence of maternal sensitisation is haemolytic disease of the fetus and newborn (HDFN). HDFN leads to destruction of fetal red blood cells and can cause severe anaemia, hydrops fetalis and, in some cases, stillbirth or neonatal death. In the UK, a policy of offering anti-D Ig to RhD-negative women following the birth of an RhD-positive baby (introduced in 1969) and to women who experience a potentially sensitising event during pregnancy (introduced in 1976), resulted in a significant reduction in deaths from HDFN (Hussey and Clarke, 1991; Chilcott et al, 2003). Introduction of RAADP, offered to all RhD-negative pregnant women, was anticipated to further reduce the rate of maternal sensitisation (Chilcott et al, 2003). The population benefit of RAADP is the prevention of one maternal sensitisation for every 278 doses administered, or around one death from HDFN for every 5790 doses administered (Pilgrim et al, 2009). The individual benefit for a particular woman is impacted by individual factors, including the blood type of the fetus, whether or not the woman will go on to have another pregnancy and, if she does, what the blood type of any future baby or babies may be.
Facilitation of informed decision-making about anti-D Ig is complex but important. Involving women in a decision-making process that takes into account personal values and individual circumstances will result in better choices; for example, if both parents are RhD-negative anti-D Ig is of no benefit. Kent et al (2014) report that about one third of RhD-negative pregnant women in the UK receive anti-D Ig unnecessarily. There is also evidence that some women who would benefit from anti-D Ig do not receive it (Bolton-Maggs, 2015). Presenting RAADP as a ‘real’ choice for women within the context of it being a recommended policy is likely to be a significant challenge (Royal College of Midwives (RCM), 1999; Kirkham, 2004).
Aim
The objective of this study was to develop an understanding of midwives' practices when offering anti-D Ig to women with an RhD-negative blood type.
Method
A descriptive, qualitative approach was chosen as the most appropriate methodology to understand the issue from midwives' perspectives. Review of existing evidence and research already undertaken (Harkness, 2014) identified a number of questions to be explored further, and focus group discussions were undertaken to gain midwives' perspectives on those questions.
The heads of midwifery of two Health Boards in Scotland were approached to request access to midwives. The two maternity units were similar in size but served different populations: one was a unit in a general teaching hospital, serving both urban and semi-rural populations and receiving tertiary referrals of higher-risk pregnancies; the other was a stand-alone maternity unit several miles from the nearest general hospital, offering low-risk care to a mainly rural population. Midwives were eligible to participate if they offered and/or administered anti-D Ig within their normal sphere of practice. Due to concerns expressed by midwifery managers over releasing staff, the date, time and venue for the focus group sessions were left to their discretion, with a 1-hour limit for each discussion agreed.
Ethical approval
The South East Scotland Research Ethics Service was approached for ethical advice. It advised that the research did not need full NHS ethical review under the terms of the Governance Arrangements for Research Ethics Committees in the UK (Department of Health, 2011).
Data collection
Two focus groups, with a total of 11 participating midwives, were conducted during 2011 (Table 1). Due to the limited time available for discussion, the researcher imposed some structure, through the use of a topic guide, in order to address the issues that had been identified as relevant.
| Frequency (n = 11) | % | ||
|---|---|---|---|
| Gender | Female | 11 | 100 |
| Male | 0 | 0 | |
| How many years out of the last 10 years have you worked as a midwife? | 7 years | 1 | 9 |
| 9 years | 1 | 9 | |
| 10 or more years | 9 | 82 | |
| In which area do you currently work? | Community | 6 | 55 |
| Day assessment unit | 3 | 27 | |
| Labour ward | 1 | 9 | |
| Antenatal clinic | 1 | 9 |
Although a topic guide was used, flexibility was also maintained to allow exploration of new areas of discussion that were considered relevant and important. The sessions were recorded and then transcribed verbatim by the researcher, resulting in significant familiarisation with the data. All information in the written transcripts was anonymised, and when data analysis and write-up were complete the audio recordings were destroyed.
Data analysis
Analysis was thematic, with aspects of the Framework Approach (Ritchie et al, 2003) used to enable detailed exploration of the predetermined topics of interest.
The researcher had previously identified a series of issues as relevant; however, the familiarisation process led to refinement of the predetermined key themes and emergence of additional key themes. This process also led to identification of initial categories; the associations/patterns within the data were identified through what Bernard (2013) describes as ‘pawing’ through the text. Some pieces of transcript were allocated to more than one key theme and/or category. The categories were colour-coded and linked to every key theme to which they related (sometimes more than one). The processes in this first stage of the data analysis were fluid and the researcher moved back and forth between them, with the key themes evolving and being refined as the categories were developed and vice versa.
Findings
The participants had all been practising as midwives for at least 7 years, prior to introduction of RAADP in their unit. They worked in a range of clinical areas including community, labour ward, admissions and assessment unit, antenatal clinic and postnatal wards.
Four key themes were identified:
Sources of information and education in relation to anti-D Ig
The midwives all described receiving education and training around the time that a policy of RAADP was introduced in their maternity unit. This had primarily concerned the changes to policy around introduction of RAADP. Only one midwife recounted being provided with information about why RAADP was being introduced:
‘They said that some of them had been missed and not known that they'd had a bleed. They said they'd looked at research and brought it out.’ (Midwife 1b)
Other means of dissemination of policy changes were described, including passing on information at team meetings and pinning a letter to a board in staff areas. The midwives reported no further education or training on this issue.
Midwives' perceptions of the benefits and risks of anti-D Ig
A distinct concept within this theme was that the participants regarded anti-D Ig given as RAADP as less clinically significant than anti-D Ig given following a potentially sensitising event during pregnancy.
‘[The benefit to the woman of receiving anti-D Ig] depends on whether or not she had any bleeding. A number of years ago we didn't do the prophylactic anti-D.’ (Midwife 1a)
RAADP was always referred to as ‘prophylactic’ to distinguish it from anti-D Ig given following birth or a potentially sensitising event. All of the midwives who participated had practised prior to the introduction RAADP, and they frequently referred to a time when they did not offer it. This was mentioned in a manner that seemed to question the importance of the intervention, and was often in relation to discussion about risk and benefit. The fact that some women decline RAADP was regularly mentioned in the same context.
‘I feel that at 28 weeks, the prophylactic, they didn't used to get it and [there] are still a lot of women who are refusing it.’ (Midwife 5a)
When asked about the potential risks of anti-D Ig, the midwives in both groups mentioned anaphylaxis—they regarded this as the most significant potential risk of the product. Although they described taking precautions and were prepared to treat anaphylaxis should it occur, they did not appear to consider it a very likely outcome.
‘There's minimal risk in receiving it [anti-D Ig]. I've never seen anyone react to it.’ (Midwife 5a)
‘No, no…’ (Others)
‘(laughing) But we take our ephedrine just in case!’ (Midwife 5a)
‘(laughing) That's right!’ (Others)
The midwives had mentioned—unprompted—that anti-D Ig was a blood product, and it appeared that most were aware of this. When asked directly about any risks associated with anti-D Ig being a blood product, they were not clear what those risks were. They also reported that they did not usually discuss those risks with women.
‘I mean, I used to say that it's screened like any other blood but there is that small risk. I would imagine? (uncertain, looking for clarification) …it is a blood product.’ (Midwife 2b)
When asked by the researcher whether they discussed with women that anti-D Ig is a blood product, one midwife said:
‘We tend not to, really.’ (Midwife 3b)
Midwives' responsibility and accountability in relation to anti-D Ig
The midwives made a clear link between professional responsibility and accountability and following policy and procedures. For example, when administering an injection of anti-D Ig prescribed by another professional, the midwives were in no doubt that they would be held accountable if an error were made.
‘At the end of the day, you're giving it, so you are accountable for it.’ (Midwife 1b)
Documentation was also considered an important aspect of the midwives' responsibility. This included documenting consent for anti-D Ig, checking blood test results and signing prescriptions.
Informed decision-making
The midwives frequently discussed using written information, specifically product information sheets and patient information leaflets. Midwives in both groups stated that they felt that the written information provided for women focused on the benefits, or reasons for accepting anti-D Ig, and did not cover the risks associated with it. They reported using these to provide information for women and as a source of information for themselves, and they did not appear to offer women much, if any, information other than that in the leaflets. The midwives did not seem confident talking about the risks of anti-D Ig, and reported that they relied on written information. When the researcher asked whether they felt able to answer women's questions about anti-D Ig, one midwife replied:
‘We just relay what's on the information sheets we give them.’ (Midwife 4b)
The process of providing written information and receiving formal, written consent seemed well-established when offering RAADP. In particular, documentation of refusal of consent was considered important. However, the process of facilitating informed decision-making seemed less clear. The midwives described their discussion with women as conveying the need for anti-D Ig because it was policy, rather than explaining the pros and cons of accepting it.
One of the midwives appeared to assume that women would have been informed about anti-D Ig during pregnancy, apparently negating a need to discuss it again when postnatal anti-D Ig was offered:
‘We tend not to really [discuss anti-D Ig with women]. By the time they get to us on labour ward they've had all the stuff and they know, pretty much, and they require it [postnatal anti-D Ig].’ (Midwife 1a)
The midwives also talked about testing a woman's partner's blood type, and conveyed that they felt there was real value in having the baby's father tested. However, they did not view it as their responsibility either to offer the test or to arrange a test if it was requested. They placed responsibility for this with the woman and her partner, with one participant suggesting that the father might donate blood to find out what his blood type was.
‘I am amazed at the amount of men that don't know… They don't give blood or anything, I tell them to give blood, to donate. “If you want to know, donate.”’ (Midwife 1)
Interestingly the midwives always referred to ‘giving’, rather than ‘offering’, anti-D.
Discussion
Provision of woman-centred care is a key aspect of maternity care policy in the UK (Department of Health, 1993; Maternity Services Action Group, 2011) and informed decision-making is at its heart. Informed decision-making about anti-D Ig is complex and was at the forefront of the debate about introduction of RAADP in the UK (RCM, 1999). It is notable that the policy documents that recommend anti-D Ig (NICE, 2008; Royal College of Obstetricians and Gynaecologists, 2011; Qureshi et al, 2014) all contain statements reiterating the importance of informed decision-making and of encouraging women to make a choice about anti-D Ig. The midwives in this research seemed to lack detailed knowledge of the risks and benefits of anti-D Ig, and did not appear to engage in a comprehensive discussion about individualised risk with women when offering it. Engaging women in this level of discussion requires midwives to have knowledge and understanding of complex issues, access to resources such as paternal blood-type testing, confidence in their own ability to engage in discussion of this nature, and additional time for that discussion.
Although previous research (Harkness et al, 2008) has found that the majority of maternity units provided education for staff at the time of implementation of RAADP, the participants in this research recalled that the information they received when RAADP was introduced at their maternity unit was simply a policy update. These findings suggest that although the maternity units met their obligation to disseminate policy change reflecting the new guidance, they did not go so far as to provide education that would enable midwives to engage with women to meet the recommendations concerning informed decision-making. This is particularly pertinent when practice changes significantly, as with the introduction of a policy of RAADP.
There is widespread provision of written information about anti-D Ig (at 97% of maternity units in the UK), with 60 different leaflets being used nationally (Harkness et al, 2008). There was, however, significant variation in quality of the information in these leaflets, with several missing key information. The midwives who participated in this focus group research reported using patient information leaflets and product inserts both to support their own knowledge and to provide information to pregnant women. However, they commented that the written information they provided focused on the reasons for accepting anti-D Ig, and did not cover risks. This resonates with published research questioning whether anti-D Ig is presented as a choice, and what exactly women understand about it (Stewart, 1999; Wickham, 1999a; 1999b; Wray, 2000). Midwives' reliance on written information raises concern about how women are able to make individualised informed decisions about anti-D Ig.
RAADP is an example of an intervention that is recommended based on a population perspective, despite individual factors greatly impacting likelihood of benefit (NICE, 2008). The midwives here described a process of providing information and documenting consent, rather than offering real choice. Kirkham (2004) warns that when care is routine there is a risk of informed compliance rather than informed consent. Organisations that develop policy at local and national level hold significant potential to influence the way that midwives practise in this regard.
Anti-D Ig is of no benefit for those women who are certain that the father of their baby is RhD-negative. Paternal blood-type testing is a simple and potentially cost-effective intervention that supports provision of individualised care through prevention of unnecessary administration of anti-D Ig. It is worth noting that although the midwives in the focus groups supported paternal blood-type testing, they did not consider offering it as an option.
Concern has been raised about the failure to consider paternal, and more recently cell-free fetal DNA, blood-type testing as a serious option for RhD-negative pregnant women (Kent et al, 2014). Qureshi et al (2014) report that the introduction of RhD typing of the fetus during pregnancy using cell-free fetal DNA, obtained through maternal blood sampling, could prevent unnecessary administration of anti-D Ig to around 40 000 pregnant women each year. None of the policy documents concerning anti-D Ig recommend paternal testing and as few as 12% of UK maternity units routinely offer it (Harkness et al, 2008). Midwives should always seek time with women when their partners are not present in order to discuss sensitive issues; this could provide an opportunity for confidential discussion about whether a paternal blood test would be appropriate. It would appear that failure at organisational level to make this option available for women has an impact on midwives' ability to fully facilitate this discussion.
Women's knowledge and understanding of the issues around anti-D Ig, together with access to appropriate investigations, may have a significant impact on their care and subsequent clinical outcomes. This is not limited to potential reduction in unnecessary administration of anti-D Ig; provision of relevant and accurate information about both the risks and benefits of anti-D Ig, discussed in the context of her own situation, may enable a woman to recognise when to seek advice and to do so in a timescale within which anti-D Ig will be effective. Midwives have a professional responsibility to enable women to make real choices about their care, but equally the organisations that employ midwives—and those that produce guidance for their practice—must recognise the influence that they hold and take action to address apparent deficits.
Strengths and limitations
A major strength of this work is that it considers the knowledge and practices of midwives, the primary professional involved in the facilitation of decision-making around anti-D Ig. However, this was a small sample from just two maternity units. The participants were all experienced midwives, which may have given them a particular perspective on the care they offered.
Conclusion
Midwives are pivotal in enabling women to make informed decisions through the provision of comprehensive, accurate and understandable information. However, with regard to anti-D Ig, midwives appear to support women's decision-making from a simplistic ‘risk basis’ rather than an individualised ‘choice and control basis’ (Jomeen, 2012).
Midwives may not have the knowledge and information to assist women in their choices about anti-D Ig, and this could be addressed through provision of high-quality written information and ongoing education. Midwives' discomfort discussing fully the issues around anti-D Ig may arise because the system does not allow them to offer real choice to women, reflecting concern about whether real choice is an option in today's maternity services (Kirkham, 2004). More effort is required to understand the difficulties that midwives face in this regard.
A meaningful debate on fetal and paternal blood-type testing is vital in order to support individualised choice and address the unnecessary administration of anti-D Ig to as many as 40 000 pregnant women each year.