Date: 10th October 2019
MAI Review of National Clinical Guideline for Intrapartum Fetal Heart Rate Monitoring
The Midwives Association of Ireland (MAI) have been contacted by members since mid to late August 2019 with concerns relating to the HSE Guideline for Intrapartum Fetal Heart Rate Monitoring.
The MAI has serious and considered reservations in respect of;
1)the style and tone of the language used;
2)the quality of evidence used and presentation of same;
3)the presentation and launch of the Guideline;
5)the quality and layout of the Information Leaflet for Women & Families;
6)the recommendation to use this Guideline & how it impacts upon Midwives professional accountability & responsibility as well as on the potential safety of mothers and babies.
Each of these is addressed in more detail below.
As with many medically framed documents about birth, the Guideline is overtly risk-focused, with an emphasis on pathologising birth. After the opening paragraph of the document (which explains the reviewing process) the first sentence of the guideline is ‘Maternity care aims to minimise inherent risks of pregnancy for both mother and baby; intrapartum care aims to minimise the inherent risks of labour’.
We would disagree with this opening statement, and perhaps it follows therefore, the entire premise of the guideline. Primarily, maternity and intrapartum care should aim to promote health and wellbeing in what is, for most women, a normal, physiological process. The language emphasising the ‘inherent risks’ of birth demonstrates a medicalised philosophy that is narrow and reductionist, that does not recognise that birth is a complex and nuanced bio-psycho-social process, and which fails to acknowledge other forms of safety (such as emotional or cultural safety) or measures that support birth physiology.
This manifest focus on risk from the opening paragraph both reflects and contributes to the problem described in the Lancet Series on Maternal Health as ‘too much, too soon’—the global health problem in both low, middle, and high income countries, of the overuse of technology in birth, leading to more intervention, sometimes unnecessary, and an increase in adverse outcomes in contrast to the equally important issue of ‘too little, too late’ where quality care and necessary interventions are not available (Miller et al 2016). This contributes to what is now seen as a global problem of dehumanised childbirth practices.
The guideline authors admit that “It is recognised from the outset that CTG has been introduced incrementally into maternity care practices and that it has well documented limitations, including poor correlation with outcome, and interpretative subjectivity”, yet go on to write a guideline that recommends this technology in any case. Favouring of any technology (regardless of efficacy or risk) over minimised (or midwifery) technology that works with and supports birth physiology and relationship-based care is part of the ‘institutional paradox’ of maternity systems and can actually increase risk for women by downplaying technological/medical risk and framing low-tech support as dangerous (Newnham et al 2018).
This bias is evident in the information leaflet intended for women to help them make an informed decision about CTG monitoring for their labour (Appendix 13.1 of the Guideline). First introducing an element of fear (‘labour can be a stressful time for all babies’), it includes a heading ‘Is there a risk in using IA’ but there is no correlating heading titled ‘Is there a risk in using CTG’. This is an example of medicalised language bias and demonstrates how the institutional paradox frames such information and therefore influences women’s decision-making towards the intervention. By omission, it encourages the assumption that there is no risk associated with continuous CTG. Even if one were to agree with the dismissal by the authors of this guideline and information leaflet, the research within the Cochrane systematic review showing increased risk of Caesarean Section (CS) and instrumental birth (note: the MAI do not concur with such a dismissal), other risks of continuous CTG, in terms of impact on birth physiology for women include;
1) reduced mobility (this is mentioned in section 5.5 of the guideline);
2) limits access to water and
3) a perceived decreased need for the midwife to stay close and supportive or even in the room (this is especially the case with central monitoring systems).
All of these possibilities bring a different set of risks to the woman, and possibly a cascade of more intervention and further risk—increased pain, pharmacological analgesia, increased fear, decreased support—all of which we know impacts on the process and outcome of birth (Newnham et al. 2018).
Under the heading ‘What is continuous CTG monitoring’ it is claimed that continuous CTG results in 50% decrease in neonatal seizures. This is cherry picking of evidence as it does not provide the balance of information as reported by the source. The omission of other findings of the Cochrane review e.g. that continuous CTG monitoring does not improve any other outcomes (other than neonatal seizures) and that the effect of this difference in children is equal by the age of 2 years and that continuous CTG is associated with an increased risk of CS and instrumental birth is misleading for women and health care providers alike. As such, the language of the leaflet could be viewed as being coercive and scaremongering in its attempt to influence women towards choosing or acquiescing to offers of a CTG. This is biased information-sharing and it is not reflective of the ethos of women centred care as espoused in the HIQA standards (Safer Better Maternity Care 2016) or indeed as in the National Maternity Strategy (2016).
- QUALITY OF EVIDENCE USED & PRESENTATION OF SAME
A) DEFINING LABOUR
The guidance on the diagnosis of labour in this Guideline is sketchy and lacks clarity. The World Health Organisation (WHO 2018) recommends that “The active first stage is a period of time characterized by regular painful uterine contractions, a substantial degree of cervical effacement and more rapid cervical dilatation from 5 cm until full dilatation for first and subsequent labours.” NICE (2017) defines labour as when there is “there is progressive cervical dilatation from 4 cm”. Clarity is required regarding the definition of ‘labour’ where it is used in the HSE Guideline to guide other actions.
The expectation that labour be self-diagnosed by the labouring woman is problematic. While it is essential that the woman’s voice be heard, as stated in NICE 2014 “When performing an initial assessment of a woman in labour, listen to her story and take into account her preferences and her emotional and psychological needs”, health care professionals require a working definition of labour. Concern has been raised that without a definition of labour, situations such as when to initiate CTG monitoring become problematic.
B) ADMISSION CTG
Of particular concern, is the key recommendation, noticeably classified as a ‘Consensus Based Recommendation’, to perform an admission CTG “as a record of fetal wellbeing at the onset of labour”, in order to assist reviews in poor perinatal outcomes. This recommendation is not based on evidence and it ignores high quality evidence, finding an absence of benefit for the Admission CTG. It reflects a biased assessment and interpretation of the existing evidence base. The most recent Cochrane systematic review on Admission CTG finds no evidence of benefit for the use of admission CTG for low risk women, and an increased risk of caesarean section. In their large Irish randomised controlled trial, Smith et al (2019) found no differences in obstetric or neonatal outcomes between intermittent auscultation (IA) and admission CTG (ACTG) for women with possible labour onset, other than an increased risk for continuous CTG in women receiving ACTG, however this evidence is not referred to in this guideline. We note that neither NICE or the WHO recommend use of an Admission CTG.
The assertion that the admission CTG is in some way to be considered a payoff in the absence of 3rd trimester screening is unfounded, without evidence and is not woman-centered. Women in the UK do not routinely have 3rd trimester screening and are not required or recommended to have ACTG (NICE 2017).
The guideline states that in relation to presence of ALL meconium, continuous CTG is advised. This advice ignores previous evidence around grading of meconium and the potential to consider reverting to IA if CTG is reassuring in the case of cases of lower grade meconium NICE (2017), HSE/IOG (2012). There is no information provided on evidence for such a recommendation.
There is no recommendation in the guideline to draw women’s attention to any of this, making the guideline’s assertion that “adherence to this Guideline will help to minimise adverse outcomes for women” (p.vii), null and void. In fact, the opposite may be true. Sadly the only element of choice alluded to in the ‘Leaflet for Women and Families’ is in relation to the sound of the CTG machine where it is stated that, “You may ask your midwife to lower the volume if you’d prefer not to listen to the heartbeat” yet no mention of a woman’s preference or autonomy around IA vs CTG.
In their letter to the BMJ, Bewley & Braillon (2018) state that “as a screening test, electronic fetal monitoring performs poorly. It has a poor positive predictive value, even with computerised interpretation of the fetal heart. This means that most of the fetuses identified as being at risk of hypoxia are not” and they quote Brocklehurst (2017). They go on to state that “Cochrane, the International Federation of Gynaecology and Obstetrics and the National Institute for Health & Care Excellence have all said that no evidence shows that human or computerised interpretation of cardiotocographs reduces the rate of intrapartum stillbirth and cerebral palsy but does cause maternal harm. INFANT showed that adding intelligent decision support to costly and demanding cardiotocography did not improve clinical outcomes for mothers or babies”.
3.PRESENTATION & LAUNCH OF THE GUIDELINE
a)Rigour of development
According to the guide to National Standards for Safer Better Maternity Services, (HIQA 2016) Theme 2, point 2.1 ‘Maternity care reflects best available evidence of what is known to achieve safe, high-quality outcomes for women and babies, and when these standards are met, people providing maternity care follow national clinical guidelines to make sure women and their babies receive the same level of safe, high-quality care…’ The MAI consider that this Guideline fails the women of Ireland and their health care providers in relation to this objective.
One of the objectives of the NWIHP in developing national guidelines is to standardise procedures used in health care in line with best available evidence to help enhance care, safety and well-being and mitigate risk and inherent avoidable injury. However, the MAI conclude that this guideline introduces elements of confusing and non-evidenced based actions which could jeopardise safety of mother, baby and health care provider and the MAI believe that it requires urgent and comprehensive review.
In respect to the rigour of guideline development, according to the AGREE II instrument (2017), a guideline should be able to demonstrate that “health benefits, side effects, and risks have been considered in formulating the recommendations”. To assert that an admission CTG in some way substitutes for the lack of ‘formal ultrasound-based screen for placental insufficiency in the third trimester’ fails to acknowledge the value and importance of a more woman-focused, cost effective and less technological approach to care (Sandal et al., 2016); including the value of continuity of care models, customised growth charts and serial measurement of symphysis fundal height (RCOG, 2014).
b) Presentation and Governance
The Guideline lacks the basic standard structured content of a guideline e.g.
I. Date of issue
II. Scope – To whom does it apply
III. Date of implementation i.e., when does it come into effect
IV. What is the distribution plan
V. Who is responsible for implementation and audit at national, regional, hospital (and unit within hospital) level(s)
VI. How is it be audited / Who will audit it /When will it be audited
VII. What mechanism is to be used to ensure staff are orientated to use of the guideline in advance of the date of introduction
MAI Review of National Clinical Guideline for Intrapartum Fetal Heart Rate Monitoring.
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Why was this Guideline not developed in line with the national standard as set down by the NCEC? Is the Guideline Committee also the approving body for same?
c) Ease of Use
There is a lack of consistency both within this Guideline and in relation to how it may interact with other existing HSE guidelines on the NWIHP website (although many of these are outdated) as to whether contractions are to be palpated and recorded for ten or for fifteen minutes at a time (section 3.2). Both intervals have been mentioned interchangeably in this Guideline. This actually reflects the mixed practices that currently exist in our maternity service despite a national clinical guideline on this (HSE 2016). 10-minute intervals are used internationally. This simple to understand and easy to use method, particularly in relation to CTG interpretation – which prints out in 10 cm /10 minute blocks has been replaced with one (although past its review date) which asserts that the Midwife must start counting at 15, 30, 45 or 60 minutes past the hour (which could correlate with the last fraction of a cm or box of the 10 minute CTG block). The contraction frequency is then collated for the following 15 minutes and there are different maximum ratios of contractions per 15 minutes allowed depending on whether the woman is parous or not. This too is confusing in the IP FHR Guideline (see page xiii of the Guideline). It is evident from discussion with midwives within our Association that a ‘mixed bag’ is now the order of the day countrywide as neither ratio is readily used by all in most hospitals which unwittingly may give rise to increased risk to mothers and babies. This poses potential safety issues for women and babies; potential serious reputational, financial and medico-legal issues for the Health Service, the State Claims Agency and for individual health care providers in relation to education of midwives and obstetricians with possible consequences in Fitness to Practice Inquiries with their relevant regulatory Bodies.
d) Key Recommendations
In relation to the key recommendations, the following queries have been raised with the Association;
- Re the 5th of the 7 Quality of Care recommendations,
i) from what date is this recommendation effective?
ii) How are the hospital Clinical Directors & Directors of Midwifery required to ascertain that staff demonstrate “a thorough understanding of these Guidelines.” What guidance is available to hospital managers in ensuring that “no professional involved in labour ward care should practice unless….”?
iii) Where does that leave the Hospital medicolegally if a Hospital finds itself unable to provide safe level of cover of Obstetricians and/or Midwives as a result of this recommendation?
- In relation to the 2nd of the 6 Risk Evaluation recommendations, the MAI wish to advise that the last sentence is incorrect and is misleading; “As there are no differences in intervention rates among women regardless of risk status, it is appropriate to offer all women an admission trace or IA”.
- In relation to the 2nd of the 7 Safety for All recommendations, the MAI wish to enquire as to the appropriateness of this responsibility being devolved to the Labour Ward Manager. Such problems would ordinarily be referred to the biomedical engineer who would liaise with the relevant company and then s/he would report to the Health Products Regulatory Authority (HPRA)? Our members have advised that there appears to be an undue emphasis on the responsibilities of midwives in this Guideline to do everything and little responsibility is detailed for other members of the health care team.
The MAI also note that the NWIHP and the HPRA have issued a 1-page document separately titled “Reporting of incidents associated with Cardiotocography (CTG) devices” and the HSE and the HPRA issued a 2-page document titled “When to Report a Medical Device Adverse Event”, the latter of which directs the user on page 1 of 2 to “report the incident (to the HPRA) via your local medical device committee, vigilance officer, quality & safety committee etc” which the MAI consider to be the appropriate mechanism but on page 2 of 2, directs the user to report directly to the HPRA. In addition to these confusing directions there is no date on either of these two documents posing potential difficulties for midwives in the event of an inquiry into an incident.
- In relation to the 6th of the 7 Safety for All recommendations, the MAI are surprised to note the issue of FBS on a breech. The National Clinical Guidelines (HSE 2017) and RCOG (2016) on the Management of Breech Presentation state it should not be used as a method of assessing fetal wellbeing.
- In relation to the 7th of the 7 Safety for All recommendations, the MAI note the ongoing confusion and mixed messaging of different guidelines and wish to advise of the potential dangers to women, babies and health care providers arising from such confusion. This requires urgent clarification.
- In relation to the 2nd of the 3 Governance recommendations, the MAI request explanation/ clarification of the use of the title “senior midwife” as this is a title associated with a pay grade and not with experience in a particular area of care or in FHR monitoring.
- In relation to the 3rd of the 3 Governance recommendations, and whilst the MAI cannot support use of this particular Guideline in its current form, the MAI respectfully suggest that any guideline worthy of implementation would contain details in relation to audit of same. We recommend that any revision of this Guideline would take due account of the need for and the method of implementation and audit trail.
- In relation to the 4th and 5th of the 6 Methods of Fetal Heart Rate Monitoring, theMAI find no basis for the reasons put forward for these 2 recommendations. Webelieve that these are in direct conflict with our obligation to the woman and herfamily and to our regulatory body, the NMBI to whom we are individuallyaccountable. The MAI is concerned that such advice was apparently “approved”by the Guideline committee who should or who ought to have been aware of thisand therefore undermines the credibility of the Guideline in its totality.
9.In relation to section 11 on page 27, the MAI notes that “an addendum on staffeducation requirements will be issued following appropriate interaction witheducational bodies. This will focus on the following; …..”, and is intrigued to hear what that may contain given our numerous serious and considered reservations in respect of this Guideline. MAI members who work for the Higher Education Institutes (HEIs) have expressed their concerns regarding the ill-advised information in this Guideline.
- Finally, the MAI is also concerned that the Guideline Committee appear to be theapproving authority for their own guideline. This is an irregular practice and froma governance point of view is a weakness in the process.
The guideline proclaims to contain material that is ‘complete, accurate and reflects international best practice’, however the MAI considers that this Guideline falls short of such claims in several respects. The biggest concern for many midwives will be the lack of acknowledgement of women’s choice and autonomy in the decision making around fetal heart rate monitoring. The overall sense of this guideline is one of a defensive and paternalistic culture where cherry-picked evidence has been used to support an argument for unrestrained use of CTG monitoring. It is disconcerting when the guideline group claims to have considered guidelines produced by the American College of Obstetricians and Gynaecologists, International Federation of Gynaecology and Obstetrics, National Institute for Health and Care Excellence, Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Society of Obstetricians and Gynaecologists of Canada; all of which are considered exemplar’s of international best practice. The MAI find it unusual that the guideline does not include a section dealing with consideration of informed consent or informed refusal, particularly since the HSE in June of this year published amendments to the national consent policy recognising a woman’s right to refuse treatment in pregnancy since repeal of the 8th amendment in 2018.
- LEAFLET FOR WOMEN & FAMILIES (QUALITY & LAYOUT)
The contents, style, tone and photographs and graphics of the Leaflet (Appendix 13.1) are particularly concerning. The challenge for healthcare professionals is to be able to provide information that is impartial, balanced and practical to ensure that the reader can make an informed choice in relation to decisions that she makes about her care in labour. In doing so, it is incumbent upon the healthcare provider to do this impartially and fairly to ensure choice is given. The MAI do not see how this is achieved with this Guideline or with this Leaflet. It is evident that the preference is to sway the reader to opt for continuous fetal monitoring. This is achieved in a number of ways e.g., in relation to the use of IA, the leaflet states that “If your baby’s heart rate changes suddenly, although rare, this change will not be detected” and “studies have shown that continuous CTG monitoring in labour reduces the risk of your baby having a seizure by approximately 50%”. What is missing from these statements is the overall incidence of neonatal seizures among the newborn. The research referred to explained that the incidence of neonatal seizures rises as the risks go up (e.g. in preterm and post term deliveries) along with the existence of other maternal and neonatal risk factors. Discussing only one side of the evidence, and indeed using it out of context, is misleading for women when they are required to make meaningful and informed choices about their options for birth. The MAI believe that such erroneous but directive messaging serve to severely undermine the supportive care model as espoused in the National Maternity Strategy.
Finally, the quality of the layout, the graphics and language used and the content of the ‘Leaflet for Women & their Families’ do not meet expected modern-day standards. The graphics of abdomens or ‘pregnant bellies of women without heads’ are outdated and dehumanizing. One graphic is stretched out of scale so much, it looks confusing and does not look professional. The information presented is very biased, paternalistic in tone, incomplete and misleading. There is no date or version number of the leaflet rendering traceability, accountability and relatability impossible although such a leaflet may well be used against a health care provider who does not “comply” with same in their efforts to provide best available evidence.
- MIDWIVES PROFESSIONAL ACCOUNTABILITY AND RESPONSIBILITY
This guideline as outlined above poses serious and considerable conflict for midwives in upholding one’s professional accountability and responsibility as detailed under the Nurses and Midwives Board of Ireland Practice Standards (NMBI 2015).
a) The MAI is disturbed by the lack of information needed to provide transparency in the process that was used to identify and appraise evidence and then to move from this evidence to recommendations e.g., the risk factors (p.12) are inconsistent with clinical indicators set out by various NICE guidelines relating to fetal monitoring. The amount of “consensus-based evidence” (n=20) versus the amount of “evidence-based recommendations” (n=9) within the key recommendations is concerning given that consensus-based evidence is widely recognised as one of the lowest quality forms of evidence (Health Service Executive 2015).
b) There is notable lack of attention given to informed decision making in partnership with the woman. The NMBI standards clearly outline the importance of providing the woman with evidence-based information in an understandable and non-threatening manner in order to empower the woman to make an informed decision (NMBI 2015). The wording of the information leaflet included in the appendices appears incomplete in places and has scaremongering / coercive elements in others. These combined factors may negate any consent given as the relevant information has not been communicated to the woman in a clear manner (HSE 2013).
c) Collaboration is key within the provision of midwifery and within maternity services, both between professionals including midwives and between midwives and women. This guideline however, appears to steer maternity service users to a path to obstetric led care rather than opening the care pathway to choices based on best available evidence, national strategy, informed consent and informed refusal, individual needs and any potential risks.
In summary, the Midwives Association of Ireland regret to have to convey our collective serious and considered reservations in respect of;
1) the style and tone of the language used;
2) the quality of evidence used and presentation of same;
3) the presentation and launch of the Guideline;
4) informed consent;
5) the quality and layout of the Information Leaflet for Women & Families;
6)the recommendation to use this Guideline & how it impacts upon Midwivesprofessional accountability & responsibility as well as on the potential safetyof mothers and babies.
Therefore, we believe that we must request its withdrawal pending a comprehensive review addressing all of the aforementioned points in line with the standards set for the development of Guidelines in Irish healthcare as per the National Clinical Effectiveness Committee (NCEC). We want to assure you of our continued commitment and support to working with the NWIHP Office in any revised edition of this or other Guideline as well as with the development of any new Guidelines. We look forward to discussing this further with you when we meet as scheduled on Monday 14th October 2019 at 10.00hrs. END
Midwives Association of Ireland Date: 10th October 2019
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