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Salehi, Sara; Hyett, Jon --- "Consent and intrapartum care" [2023] PrecedentAULA 7; (2023) 174 Precedent 29


CONSENT AND INTRAPARTUM CARE

By Dr Sara Salehi and Professor Jon Hyett

Pregnancy is usually a joyous occasion for pregnant patients, their partners and support persons. The opportunity to work with pregnant patients and their families is one that healthcare workers enjoy and value. The practice of obstetrics is unique in medicine for a number of reasons: many aspects of management focus on prospective prevention and risk mitigation; decisions have an impact on outcomes for two (and sometimes more) beings; and decisions are influenced not only by evidence-based medical practice but also by the values and choices of the people involved.

Although pregnancy and delivery are normal, physiological processes, outcomes of spontaneous labour can vary widely and, without intervention, include risks of significant maternal and/or fetal morbidity and mortality. Risks of an adverse outcome can, for the most part, be easily mitigated and it would not be appropriate to offer a purely expectant and reactive model of care.

The current structure of antenatal and intrapartum care used in most English speaking and Commonwealth countries is based on a model of care developed in the 1920s. The main aim of intervention at this time was to reduce maternal mortality. The maternal mortality rate in 1920s Europe was approximately 400 per 100,000 pregnancies;[1] by 2020 this rate was less than 10 per 100,000 pregnancies.[2] As the rate of maternal mortality has decreased, more emphasis has been placed on reducing morbidity associated with childbirth and ensuring that mothers and families are positively engaged in their pregnancy experience. The introduction of technologies such as ultrasound in the 1970s allowed us to see the fetus, shifting the emphasis of care from one focused on the mother to one that recognises risks to both mother and fetus, and works to reduce morbidity for both parties.

In contemporary Australian obstetric practice, approximately 85 per cent[3] of pregnant people will labour, including 30 per cent who have labour induced.[4] Almost all women have some intervention during labour (only 60 per cent will have a normal vaginal delivery without medical assistance[5]); 15 per cent of women will have an emergency caesarean section and 10 per cent will have an instrumental delivery.[6] This article addresses, from a medical perspective, the issues involved in obtaining informed consent from women about the risks that they may face during labour.

INFORMED CONSENT

The medical perspective of consent may differ from a legal one, so we will start by defining our understanding of this term. The concept of ‘informed consent’ underpins good medical practice and relies upon the tenant that patients have a right to make decisions about their medical care.[7] Based on this, no operation, procedure or treatment may be undertaken without prior consent from the patient.[8] The healthcare practitioner has a responsibility to ensure that the patient is appropriately informed about their options for treatment, potential outcomes and the possible material risks and benefits.[9]

A clinician’s frame of reference for what constitutes informed consent has changed over the past 20 years, moving away from the ‘Bolam test’, which asks whether a healthcare practitioner’s decision would be supported by an expert medical cohort.[10] Judgments such as Rogers v Whitaker,[11] Montgomery v Lanarkshire Health Board[12] and KS/XT v Calvary and Foote[13] demonstrate that failure to appropriately warn patients of material risks associated with a procedure or intervention may result in a case for negligence.[14]

Material risk

A risk is considered material if a reasonable person in that patient’s position, if warned of the risk, would likely attach significance to it.[15] Furthermore, a healthcare worker should be aware if a particular patient is likely to attach significance to a certain risk.[16] Ideally, a discussion about consent for intrapartum management would include both quantitative risk analyses and a discussion with a patient about how she would like her labour and delivery to proceed. This can be problematic as risks can vary significantly based on a patient’s circumstances. The majority of women and their supporters will also not have laboured previously and will have minimal insight into how labour and birth will affect them.

There are many different models of obstetric care, and continuity of care between patients and their healthcare providers provides an opportunity to discuss issues that are important to the individual patient and to assess the patient’s values and attitude to risk. Ideally, continuity of care will be personalised and involve the same provider from the antenatal to the intrapartum period so that issues about intervention have been addressed prior to labour. This model of care is expensive – it means carers have less flexibility to look after large numbers of women. As such this model of care is largely found in the private system. For a similar model to be introduced into the public system, there would need to be a societal decision that investment in one-to-one care is of value to the community.

Many models of care do not provide continuity through a single carer so teams of healthcare professionals need to communicate well and provide a consistent message. Women are often asked to develop a birth plan, which includes a series of statements about what they would like to achieve during labour, but it is important to make sure that this plan is pragmatic and has flexibility as the course of labour often moves from the ideal path.

Capacity

A fundamental requirement of the consent process is the concept of capacity, whereby patients are assumed to have the capacity to make decisions unless proven otherwise.[17] The pillars of capacity include the ability to comprehend and retain information, use and weigh up the information and communicate one’s final decision.[18] Mental capacity is also recognised to be fluid, meaning it can fluctuate over time and in different situations.[19]

Difficulties in intrapartum consent arise during unplanned labour and birth-related procedures and interventions, and special care must be undertaken when labouring persons are sleep deprived, in pain or under the influence of narcotic analgesia.[20] Concerns regarding obtaining consent in an emergency in the labour ward are addressed in research by Nicholls et al, whereby healthcare workers expressed concerns of ‘negligible engagement from the pregnant woman concerned who might be suffering from pain or fatigue’.[21] This concept was investigated by Singh et al through a retrospective assessment of capacity within 24 hours of a labour ward emergency; the authors identified extreme pain to be a risk factor for impaired capacity during labour.[22] The natural solution to these intrapartum challenges is for consent to be obtained antenatally before emergencies arise, however, this brings its own set of challenges.

The issue of capacity also has an impact on obstetricians’ ability to continue to investigate the value of interventions in labour.[23] Most medical interventions will be assessed through a clinical trial comparing the innovative treatment to usual ‘standard’ care. The ethical process of conducting a clinical trial requires consent – but a trial in labour may not be relevant to the majority of women (making it inappropriate to ask for their consent antenatally) but may be difficult to describe to the woman in active labour (due to limited capacity). A consequence of these difficulties is that there have been very few trials conducted while women are in labour.

WHEN TO OBTAIN CONSENT

Ideally, discussions regarding the various pregnancy and birth-related tests, procedures and interventions should occur early and repeatedly throughout antenatal care. This allows the pregnant person time to comprehend the information provided, ask questions, express their preferences and, where required, provide informed consent.[24]

In a small randomised prospective study, Ayling et al recruited pregnant persons at 36 weeks to take questionnaires to assess their ability to understand and retain information. This study identified that patients receiving information in late pregnancy and in labour may understand and retain information better than those who only receive it while in labour.[25] Given the small size of this study, further research is required to support its findings and it must be recognised that, when in labour, pregnant persons may not be able to recall information previously discussed in the antenatal period.[26]

Another important aspect of antenatal discussions surrounding possible intrapartum interventions is the over-medicalisation of what is a ‘normal physiological event’.[27] The NSW Health Policy Directive Maternity – Towards Normal Birth in NSW warns against ‘unnecessary interference in the natural process [which] may disturb the expected course and may lead to a cascade of intervention’.[28] Alternatively, the NSW Health Consent to Medical and Healthcare Treatment Manual advises that written consent be obtained (where practicable) for unplanned birth-related procedures and interventions.[29] There is concern that obtaining consent from all pregnant persons for all potential intrapartum risks and interventions, when 60 per cent will progress to have a normal vaginal delivery without medical assistance, will induce unnecessary anxiety and potentially excessive intervention. Alternatively, delaying obtaining consent to the intrapartum period raises concerns regarding capacity and lack of time to truly comprehend the decisions that are being made.[30] The provision of group antenatal classes and other education is not new and such classes can be useful, however, the information provided may be of variable quality and does not meet the criteria required for informed consent.

Consent for specific treatment or procedures

The Consent to Medical and Healthcare Treatment Manual divides its procedures requiring consent into planned and unplanned interventions. Obtaining consent for specific planned procedures has the benefit of allowing the pregnant person to consider their options and express their wishes and preferences. It also allows the healthcare worker to identify what that particular patient is likely to attach significance to, and therefore determine the material risks that need to be discussed in order to obtain valid consent.[31] Examples of planned interventions include elective caesarean sections, induction of labour and vaginal birth after caesarean section.

Current consent guidelines do not require consent for spontaneous vaginal birth,[32] likely because vaginal birth with no intervention is considered a normal process.[33] There are, however, known risks associated with labour and a vaginal delivery, including the aforementioned 15 per cent risk of an emergency caesarean section and 10 per cent risk of instrumental delivery.[34]

One significant complication of vaginal delivery that has become of significant concern to women in recent years is obstetric anal sphincter injury (OASI). Approximately 6 per cent of women will sustain a third or fourth degree tear – injury to the anal sphincter – during the course of delivery.[35] In 80 per cent of cases the sphincter will be repaired with no deleterious long-term effects for the mother, but in 20 per cent of cases women may have long-term faecal incontinence. The absolute risk of faecal incontinence being a complication of vaginal birth is estimated to be 0.5–1.0 per cent.[36]

Risks for individual women will vary. Risks are higher for women in their first pregnancy who deliver a larger (>4kg) baby, and are higher for Asian than Caucasian women. Some features of labour are also associated with increased risk, such as a prolonged second stage and instrumental delivery.[37]

This gives rise to a number of questions about informed consent for vaginal birth. Should women be informed of the risk of OASI? If so, which risk is significant – the 6 per cent risk of a third or fourth degree tear, or the 0.5 per cent risk of long-term faecal incontinence? Is it reasonable to request an elective caesarean section on the basis of these risks, and how do they compare to the risks of this operative procedure? Should risks be individualised despite the fact that risk calculators have poor efficacy, and should risks be redefined as labour progresses to take account of other intrapartum factors? None of these questions have been adequately answered through research.

Elective caesarean section is also associated with recognised short-term complications and has significant implications for future pregnancies.[38] While elective caesarean sections are not routinely offered as an alternative to vaginal delivery in circumstances where there are no obstetric or medical indications for abdominal delivery, the number of women requesting an elective caesarean section is increasing.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) provides a guideline for Caesarean Section on Maternal Request, which advises an elective caesarean section can be offered to patients who demonstrate an understanding of the relative risks and benefits of the procedure.[39] In light of the availability of this alternative form of delivery, obtaining consent for a vaginal birth is not completely out of the realm of autonomous patient-centred care and has been advocated in some jurisdictions.

Perhaps the most difficult time to obtain informed consent is in circumstances where an unplanned intervention is needed, in either the delivery room or operating theatre, in response to an event suggestive of acute fetal compromise. The nature of the birth process is such that the risks of birth can change suddenly and may require immediate and unexpected intervention. The Consent to Medical and Healthcare Treatment Manual advises that written consent is not required in an emergency to save a life, however, a woman’s implied or oral consent should be recorded.[40]

Issues surrounding capacity while labouring have already been addressed and are still applicable to emergencies in the labour ward. Additionally, the dynamic nature of the labour ward is such that often the obstetrician who is advising a potentially lifesaving procedure, such as an instrumental delivery or emergency caesarean section, is meeting the pregnant person for the first time. As such, in a short amount of time the healthcare worker is expected to explain the nature of the situation, describe the proposed treatment and discuss the material risks and benefits,[41] all while cognisant of the fact that as time progresses, risk increases. Trying to ascertain an individual’s preferences and concerns and therefore tailoring a consent process accordingly is incredibly difficult in a short amount of time. The uncertainty of determining materiality demonstrates that the significance of risk cannot be determined purely through a numerical likelihood, and in fact value-based healthcare plays a fundamental role in the consent process.[42]

Vaginal birth after caesarean section presents another conundrum for the obstetrician. Many women who did not deliver vaginally in their first pregnancy express disappointment about this, and a desire to achieve vaginal delivery in their second pregnancy. Caesarean section leaves a fibrous scar on the uterus that is less elastic and less able to absorb contractions than unscarred uterine tissue. As a consequence, labour following caesarean section is associated with a small but not insignificant risk of uterine rupture (approximately 1 in 200 spontaneous labours).[43] The significance of such an event is that the fetus may spill into the maternal abdomen and become hypoxic – and there is a 1 in 1,000 risk of intrapartum hypoxic ischaemic encephalopathy with permanent disability.[44]

For many women, the risk of 1 in 1,000 of a catastrophic outcome is low compared to the emotional value of being able to attempt and potentially succeed with vaginal birth. Risks may be increased in some circumstances, such as with induction of labour, and pregnancies are monitored more intensively during labour which may be intrusive for the mother. For many women, the obstetrician’s emphasis on risk is disproportionate. From an obstetrician’s perspective, in a unit of 5,000 deliveries per year and an anticipated 750 vaginal births after caesarean section, three women will rupture their uterus and one will have a baby who is damaged through this process – a potentially avoidable complication of childbirth.

Consequently, in some units, women are asked to sign a consent form documenting their understanding of the risks of attempting vaginal birth after caesarean section.

Coercion

A fundamental requirement of valid consent is that it must have been given freely, absent of any pressure or coercion from healthcare workers or others.[45] This requirement reflects the move away from a paternalistic approach to healthcare provision, recognising patients as rational beings able to comprehend appropriately communicated risk information.[46]

One rationale for intervention is a perception of ‘danger to life’. From an obstetrician’s perspective, timely intervention is designed to remove this risk, resulting in the safe live birth of the fetus. From the patient’s perspective, the delivery of an infant who is well, with no evidence of the anticipated deleterious effect, is balanced against the impact of the intervention, and may lead to the conclusion that they were falsely led down a path of intervention. This can be demonstrated by two scenarios.

Scenario 1

A woman attends the antenatal clinic ten days beyond her due date and has not yet gone into spontaneous labour. The pregnancy has been uncomplicated and assessment at this visit is unremarkable. She would like to wait for spontaneous labour. The obstetrician advises that the risk of stillbirth is increasing and becomes more pronounced after 42 weeks, with a prevalence of 1 in 300 pregnancies.[47] The cause of stillbirth is poorly understood, and it is therefore difficult to guard against. The obstetrician advises that the woman is induced, introducing a series of interventions and an increased level of monitoring during labour. The most likely outcome is normal vaginal delivery of an infant who is well with no obvious deleterious effect of being ‘postdates’.

Most obstetricians would advocate induction by 42 weeks’ gestation and would consider that the level of intervention is worthwhile to prevent a catastrophic outcome. Some women may be relatively risk averse and, when informed that induction of postdates pregnancies does not necessarily increase the rate of caesarean section,[48] may be prepared to agree to this intervention. Others may be more sanguine about the level of risk of a catastrophic outcome and more concerned about the impact of these interventions on their planned birthing pathway. Risk calculators for risk of stillbirth have been proposed, but have poor screening efficacy;[49] until we have better tools for assessment, we need to continue to have an informed discussion about relative risks and the pros and cons of intervention.

Scenario 2

Another circumstance in which women have reported being coerced into operative (instrumental or caesarean) delivery involves identification of fetal distress during labour.[50] Cardiotocography (CTG) is often used to monitor fetal wellbeing in labour, and although this form of screening has high sensitivity it has poor specificity for identifying the acidotic fetus.[51] An abnormal CTG identifies a fetus at high risk of being acidotic, but the risk is not absolute – and the intent is to deliver the fetus before a birth injury is sustained. In some circumstances, the obstetrician will identify the abnormal CTG as an indicator for emergency caesarean section; if the procedure goes well the fetus will be healthy (and not acidotic) at birth. From an obstetrician’s perspective this is a good outcome but from the patient’s perspective it may appear that they were coerced into unnecessary abdominal delivery.[52]

While the discussion about the relative merits of induction of labour can occur over a number of clinic visits, the imminent risks associated with fetal distress in labour often lead to abridged communication between stressed medical staff and vulnerable patients. Anthropology shows that women are most likely to labour well when they feel secure and safe;[53] prolonged antenatal discussion about the potential need for emergency intervention may be of value for the one in ten women who have this outcome but may be unnecessary and even detrimental for the majority.

The challenge in consent discussions during time-pressured situations in the labour ward is finding the balance between providing advice – guided by experience and qualifications – which is not coercing patients towards a certain decision. This challenge needs to be faced while recognising that in these high-risk situations, one does not have the luxury of a significant amount of time to allow for thoughtful consideration of the options.

CONCLUSIONS

Up to 45 per cent of women have reported that their birth experience was traumatic.[54] This can lead to ongoing anxiety and depression and impact on a woman’s ability to interact with her child, partner and other family members. One in 20 women have been reported to have symptoms of post-traumatic stress disorder (PTSD) after childbirth. A complicated labour and the need for an emergency caesarean section are recognised risk factors for PTSD.[55]

It is important to ensure that women are well-informed about the process of labour and their progress while in labour. Women need to be supported in making decisions about interventions, which may be enhanced through pre-emptive discussion as labour unfolds. Further research is needed to identify and promote the value of continuity of care and of a formal post-delivery debrief in reducing the psychological morbidity associated with childbirth.

Dr Sara Salehi is Clinical Research Fellow and Specialist Registrar in Obstetrics and Gynaecology.

Professor Jon Hyett is Professor of Obstetrics and Gynaecology at Western Sydney University. He is an Obstetrician and Specialist in Maternal and Fetal Medicine.

They are both members of the Obstetric Research Group at The Ingham Institute for Applied Medical Research, South Western Sydney Local Health District. PHONE 0437 925 032 EMAIL jon.hyett@health.nsw.gov.au.


[1] I Loudan, ‘The transformation of maternal mortality’, British Medical Journal, Vol. 305, 1992, 1557–60.

[2] C Diguisto, M Suacedo, A Kallianidis, K Bloemenkamp, B Bodker, M Buoncristiano, S Donati, M Gissler, M Johansen, M Knight, M Korbel, A Kristufkova, L Nyflot and C Deneux-Tharaux, ‘Maternal mortality in eight European countries with enhanced surveillance systems: descriptive population based study’, British Medical Journal, Vol. 379, 2002.

[3] Australian Institute of Health and Welfare (AIHW), Australia’s mothers and babies: Onset of labour (2022) <https://www.aihw.gov.au/reports/mothers-babies/australias-mothers-babies/contents/labour-and-birth/onset-of-labour>.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Australian Medical Council Limited, Good Medical Practice: A Code of Conduct for Doctors in Australia, 1st ed (2009) 10–11.

[8] Corporate Governance and Risk Management, Consent to Medical and Healthcare Treatment Manual, 1st ed (NSW Health, 2020) 11.

[9] Ibid; Australian Commission on Safety and Quality in Health Care, Informed Consent in Healthcare (2020) <https://www.safetyandquality.gov.au/sites/default/files/2020-09/sq20-030_-_fact_sheet_-_informed_consent_-_nsqhs-8.9a.pdf>.

[10] S Chan, E Tulloch, E Cooper, A Smith and W Wojcick, ‘Montgomery and informed consent: Where are we now?’, British Medical Journal, Vol. 357, 2017.

[11] [1992] HCA 58.

[12] [2015] UKSC 11, [87].

[13] [2018] ACTSC 84.

[14] Consent to Medical and Healthcare Treatment Manual, above note 8.

[15] Ibid, 16.

[16] Ibid.

[17] NSW Government, Capacity Toolkit Factsheet (2022) <https://www.justice.nsw.gov.au/diversityservices/Documents/factsheet_english.pdf>.

[18] N Singh, P Lepping, R Whitaker, B Masood, S Joshi and P Banfield, ‘Incapacity in childbirth – Rare or common?’, European Journal of Obstetrics & Gynaecology and Reproductive Biology X, Vol. 10, 2021, 1–6.

[19] The Law Society of NSW, When a Client’s Mental Capacity is in Doubt: A Practical Guide for Solicitors (2016) 6 <https://www.lawsociety.com.au/sites/default/files/2018-03/Clients%20mental%20capacity.pdf>.

[20] Royal College of Obstetricians and Gynaecologists, Obtaining Valid Consent: Clinical Governance Advice (2015) <https://www.rcog.org.uk/media/pndfv5qf/cga6.pdf>.

[21] J Nicholls, A David, J Iskaros and A Lanceley, ‘Patient-centred consent in women’s health: Does it really work in antenatal and intra-partum care?’, BMC Pregnancy and Childbirth, Vol. 22, 2022, 4.

[22] Singh et al, above note 18.

[23] H Phipps, B De Vries, S Kuah and J Hyett, ‘When should women be recruited to intrapartum research projects? A retrospective review’, Acta Obstetricia et Gynecologica Scandinavica, Vol. 92, 2013, 1264–70.

[24] Consent to Medical and Healthcare Treatment Manual, above note 8, 18.

[25] L Ayling, A Henry, S Tracy, C Donkin, N Kasparian and A Welsh, ‘How well do women understand and remember information in labour versus in late pregnancy? A pilot randomised study’, Journal of Obstetrics and Gynaecology, Vol. 39, 2019, 913–21.

[26] Royal College of Obstetricians and Gynaecologists, Obtaining Valid Consent: Clinical Governance Advice (2015) <https://www.rcog.org.uk/media/pndfv5qf/cga6.pdf>.

[27] NSW Government, Maternity: Towards Normal Birth (2010) 1 <https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2010_045.pdf>.

[28] Ibid.

[29] Consent to Medical and Healthcare Treatment Manual, above note 8, 57.

[30] Nicholls et al, above note 21, 5.

[31] Consent to Medical and Healthcare Treatment Manual, above note 8.

[32] Ibid, 57.

[33] Maternity: Towards Normal Birth, above note 27.

[34] AIHW, above note 3.

[35] Royal College of Obstetricians and Gynaecologists, The Management of Third and Fourth Degree Perineal Tears (2015) 5 <https://www.rcog.org.uk/media/5jeb5hzu/gtg-29.pdf>.

[36] Ibid, 6.

[37] Ibid, 6–7.

[38] J Sandall, R Tribe, L Avery, G Mola, G Visser, C Homer, D Gibbons, N Kelly, H Kennedy, H Kidanto, P Taylor and M Temmerman, Short and long-term effects of caesarean section on the health of women and children’, The Lancet, Vol. 392, 2018.

[39] The Royal Australian College of Obstetricians and Gynaecologists, Caesarean Delivery on Maternal Request (2017) 3 <https://ranzcog.edu.au/wp-content/uploads/2022/05/Caesarean-Delivery-on-Maternal-Request-CDMR.pdf>.

[40] Consent to Medical and Healthcare Treatment Manual, above note 8, 57.

[41] Ibid, 9.

[42] K Fulford, ‘Values-based practice: A new partner to evidence-based practice and a first for psychiatry?’, Mens Sana Monographs, Vol. 6, 2008, 10–21.

[43] The Royal Australian College of Obstetricians and Gynaecologists, Birth after previous caesarean section (2019) 9 <https://ranzcog.edu.au/wp-content/uploads/2022/05/Birth-after-previous-caesarean-section.pdf>.

[44] Ibid.

[45] Consent to Medical and Healthcare Treatment Manual, above note 8, 12.

[46] Nicholls et al, above note 21, 2.

[47] J Muglu, H Rather, D Arroyo-Manzano, S Bhattacharya, I Balchin, A Khalil, B Thilaganathan, KS Khan, J Zamora and S Thangaratinam, ‘Risks of stillbirth and neonatal death with advancing gestation at term: A systematic review and meta-analysis of cohort studies of 15 million pregnancies’, PLOS Medicine, Vol. 16, 2019, 1–16 at 1.

[48] M Hannah, W Hannah, J Hellmann, S Hewson, R Milner and A Willan, ‘Induction of labor as compared with serial antenatal monitoring in post-term pregnancy. A randomized controlled trial. The Canadian Multicenter Post-term Pregnancy Trial Group’, New England Journal of Medicine, Vol. 326, 1992, 1587–92 at 1.

[49] A Trudell, M Tuuli, G Colditz, G Macones and A Odibo, ‘A stillbirth calculator: Development and internal validation of a clinical prediction model to quantify stillbirth risk’, PLOS One, Vol. 12, 2017, 1–13.

[50] R Reed, R Sharman and C Inglis, ‘Women’s descriptions of childbirth trauma relating to care provider actions and interactions’, BMC Pregnancy and Childbirth, Vol. 17, 2017, 5.

[51] R Beard, G Filshie, C Knight and G Roberts, ‘The significance of the changes in the continuous fetal heart rate in the first stage of labour’, The Journal of Obstetrics and Gynaecology of the British Commonwealth, Vol. 78, 1971, 865–81.

[52] Reed et al, above note 50.

[53] M Walter, H Abele and C Plappert, ‘The role of oxytocin and the effect of stress during childbirth: Neurobiological basics and the implications for the mother and child’, Frontiers in Endocrinology, Vol. 12, 2021.

[54] D Ertan, C Hingray, E Burlacu, A Sterlé and W El-Hage, ‘Post-traumatic stress disorder following childbirth’, BMC Psychiatry, Vol. 155, 2021, 1–9 at 1.

[55] Ibid.


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