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From the time of Hippocrates until late into the 20th century it was generally accepted practice that the doctor knew best and it was not beneficial for the patient to know all the possible risks they were facing when agreeing to a procedure. It has been argued that we are cruel listing all potential risks when all the patient really wants is to be made better, no matter how that is done to them (within reason).
For this essay I will limit my attention to consent being obtained for procedures being performed on the labour ward (due to time and word pressures). I will address the principles upon which I understand the Montgomery ruling has been based and these can be translated into any conceivable situation.
In order to provide valid fully-informed consent the patient must have the mental capacity to make the decision, be provided with the relevantinformation and be free from coercion.
As any clinician should know, the Montgomery ruling applies to any procedure where there is a reasonable alternative and in these situations the duty of the clinician is to determine what risks the patient would want to know. This can be a very difficult process to get right, as the consent process is often conducted in tense moments when the outcome for the baby (+/- mother) may be in the balance and any delay could result in significant harm to either or both. A review of settled claims since Montgomery has demonstrated a 10% increase in claims where consent was the main or significant issue. The doctor has a few minutes to get the process right whereas the patient has the luxury of months or years to consider whether they would have taken the same path if alternative information had been provided.
Examples on the labour ward that an obstetrician faces on a daily basis include the following:
Category 1 caesarean in the first stage of labour –
There is an immediate threat to the maternal or fetal wellbeing requiring urgent delivery; timescale 10-30 minutes depending on urgency.
It is clear that in this situation if a caesarean section is not performed the baby would be harmed and could die. There is no (reasonable) alternative butto perform a caesarean section and therefore the degree of information could be limited to “I need to deliver your baby by caesarean section immediately otherwise it could suffer permanent harm. Is that ok?”. The patient nods and the procedure is performed without delay. No further information or exchange of words is required (although I have been involved in a case where the mother did say no and the baby died – her choice, or possibly, and more likely in her case, her family’s choice). No formal consent form should be signed as this adds delay which I would argue is unreasonable. Gone should be the days of seeing patients being wheeled down the corridor with a (usually) very junior doctor shoving the consent form in the patient’s face insisting they sign it.
Trial of instrumental delivery in theatre:
This is performed at full dilatation and usually when there has been delay in the second stage. The obstetrician has made an assessment in the room and is not confident that a vaginal delivery will be completed. There is, therefore, an inherent failure in the process following which a potentially very difficult, and damaging for both mother and baby, caesarean section would follow. In this situation there is time to discuss the options, of which there are two: namely, go for the trial and the possible even more complicated caesarean or not even attempt the trial and go straight for delivery by second stage caesarean section. Both options have significant complications and there is little evidence to provide relative risks to the mother other than to say that the caesarean section following a failed instrumental delivery may have increased risk of complications, especially to baby. The problem is that by this stage most women will be extremely tired, stressed, in considerable pain and very concerned for their baby. It is debatable whether a court would deem that she was of sound mind not unduly influenced by other factors (concern for her baby, putting its interest before hers). A suitable option when there is no analgesia would be to discuss the options briefly and suggest that she is moved to theatre for a spinal (which will remove the pain) and then discuss the situation more fully.
Just the other week, after I had a ‘meeting of experts’ in a consent case, I had the opportunity to obtain a woman’s consent for a trial of instrumental delivery. I had barely started with the various risks when she said, “I trust you doctor, do what you have to” and clearly did not want any further information. What is important in these cases is not the piece of paper with her signature but the contemporaneous notes (i.e. those notes written before any knowledge of complications) detailing the extent (or lack) of the conversation in which her consent was obtained for whatever was going to happen.
Many complications can arise following a trial of instrumental delivery including, but not limited to, third- and fourth-degree perineal tears, fractured fetal bones, intracerebral bleeding, hypoxia, ureteric damage, massive haemorrhage etc... If there is a poor outcome and the patient makes a claim, it could be attractive for lawyers to look at the consent process in the cold light of day and to state that it was deficient. Most women will confirm they signed a consent form (difficult to deny) but could state that they have no recollection of any information provided to them in order for them to give informed consent for the procedure that resulted in the harm they now suffer (difficult to prove otherwise). Without good contemporaneousdocumentation detailing as best possible the discussion, there is room for a court to find in favour of the claimant, perhaps erroneously.
Capacity:
I have been involved in two very different cases of capacity, one where it fluctuated due to paranoid schizophrenia and another in a patient with learning difficulties. I have also been instructed to provide an opinion in a case where a woman refused intervention during labour because she lacked capacity at the time (degree of learning difficulty not recognised antenatally) and it took 40 minutes for her to allow instrumental delivery by which time her child suffered irreversible brain damage. Where capacity fluctuates it is necessary to discuss at length with the woman what her preferences are and then seek a Court Order to ensure that should she lose capacity in labour a good outcome can follow. In this case we prepared an 11-page birth plan to cover all eventualities. When capacity is lacking then the doctor has to make the decisions as would be expected with the patient’s best interest in mind. An elective caesarean section (possibly under GA with severe learning difficulty) may well be the best option.
So, has Montgomery changed my practice? Yes and no. I have always and will continue to provide as much information that my patients require,tailored to what I perceive to be the amount of information they wish to have. What has changed perhaps, is the documentation of our discussions. I may also start my discussions with the words “how much do you want to know?”.
However consent is obtained it should be remembered that it is a process, not a single point in time and not only should you describe the risks of any path taken, e.g. 3:1,000 risk of uterine rupture with TOLAC (trial of labour after caesarean), but also the consequences of that complication, i.e. 6-10:10,000 risk of brain damage or death of the baby (same as for a first-time mother).
There is a move towards obtaining consent for any eventuality in the antenatal period. This is already in place in the US where patients are given information about potential interventions; but I feel this could result in information overload and most women would probably not relate the intervention to them as they would be expecting a normal vaginal delivery (which currently remains the default option – a discussion for another article...).
No matter how the consent process is conducted it is clear that women need and deserve all the information pertinent to them in order to make the right choice for them, even if it could be deemed the wrong choice medically. Doctors do not, however, have to remain completely impartial and can guide a patient to what they perceive is the correct choice, e.g. if they believe that the trial of instrumental is highly likely to succeed then the information about the risks can be weighted accordingly, but very carefully. As long as the women are happy to accept the consequences of whatever decision they have taken then consent will have been appropriately obtained.
References
Bolton H. The perils of taking written consent for operative delivery during labour. BJOG, 2015:1251
Devaney S, Purshouse C et al. The far-reaching implications of Montgomery for risk disclosure in practice. Journal of Patient Safety and Risk Management, 2019, Vol 24(1): 25-29
Dunn M, Fulford K, Herring J, Handa A. Between the reasonable and the particular: deflating autonomy in the legal regulation of informed consent to medical treatment. Health Care Analysis (2019) 27:110-127.
Edozien L. Consent to treatment: patient self- determination is more important than professional judgement. BJOG 2014:855
Tobias J, Souhami R. Fully informed consent can be needlessly cruel. BMJ 1993; 307:1199-1201
Wald D, Bestwick J, Kelly P. The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent
to treatment. QJM: an international journal of medicine, 2020, 1-5
Webster v Burton Hospitals NHS Foundation Trust [2017] EWCA Civ 62. One of the first cases I ever prepared a report on, in 2005, which failed on Bolam but later succeeded on Montgomery (I believe one of the first to do so)
Declaration of conflicting interest.
I prepare medico-legal reports for both Claimant and Defendant solicitors on consent and other obstetric and gynaecology issues
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