Systemic issues with informed consent in obstetrics

Forceps, vacuum or caesarean section - and where's the information?

Tahlia had a healthy first pregnancy - all the tests and scans were normal, and she went into spontaneous labour at 40 weeks and four days. She chose an epidural analgesia for labour. Tahlia’s first stage lasted 12 hours, and she had been pushing for 1 hour 45 minutes when the midwife recommended calling in the obstetrician as progress had stalled. The obstetric registrar attended and found the baby to be midway down the birth canal. The medical records reflect that a conversation took place, the use of forceps was discussed, and Tahlia’s son was born 15 minutes later in good condition. An episiotomy was discussed, carried out and repaired. There was no anal sphincter injury.

Tahlia’s initial recovery was straightforward, but by six weeks, she felt a lump in her vagina. Her GP diagnosed an anterior vaginal wall prolapse and referred her to a pelvic floor physiotherapist who, after an initial assessment and two further visits, recommended a vaginal pessary to hold the prolapse back. It’s two years down the line, and Tahlia still has a prolapse. But she doesn’t recall being warned about this - either during pregnancy or her labour.

Our understanding of the links between childbirth, instrumental birth and maternal pelvic floor injuries is mature. You can download a review article published this month by a world expert, which includes images and a high-level overview.

Informed consent for medical interventions

Legal folk don’t need me to outline the requirements for consent, which are well-known to you. And, if you ask most doctors about the consent process, they will give you a solid explanation of what’s involved. We are exposed in various ways through medical and postgraduate training and thereafter.

Examples of this include:

Medical Board Code of Conduct -sections 4.3.1, 4.3.3, 4.3.4, 4.5.1 and 4.5.2 include wording such as

“asking for and respecting their views about their health, and responding to their concerns and preferences… Informing patients of the nature of, and need for, all aspects of their clinical management… adequate opportunity to question or refuse intervention and treatment… Discussing with patients their condition and the available management options, including their potential benefit and harm and material risks… a person’s voluntary decision about medical care that is made with knowledge and understanding of the benefits and risks involved.”

Medical indemnity providers offer advice to us about how to avoid the lawyers (my emphasis):

“Your obligation includes disclosing the general risks of the treatment options. These risks will include, for example, the known complications of a procedure, common side effects and revision rates. While it is important to know and disclose these risks, it only goes part way to fulfilling your legal obligation.

This may be particular to obstetrics because the case is related to our speciality, but obstetricians are likely to have come across discourse in the medical literature about Montgomery, even though it’s a UK case. A few years ago, it was central to the conversations about the proposal for consent for vaginal birth discussed with the Australian College of Midwives at a RANZCOG meeting in Sydney.

Understandably, consent in childbirth has been reviewed thoroughly in medical ethics literature, and here it has been noted (again, my emphasis):

Thus, giving birth in a hospital (with the attendant intimate examinations), having an assisted delivery and having an emergency caesarean section are all eventualities that are reasonably likely to occur, along with their associated morbidities. Given that labour is likely to be a time of high stress, where the mother may be in significant pain, discussing risks and benefits of different birthing interventions for the first time at this point is undesirable.

RANZCOG don’t disagree, and their guidelines on consent support seeking understanding about which material risks are important for individuals:

A risk will be considered material if, in the circumstances of the particular case, a reasonable person in the position of the patient, if warned of the risk, would be likely to attach significance to it, OR if the medical doctor is aware, or should reasonably be aware, that the particular patient, if warned of the risk, would be likely to attach significance to it. Thus, when considering the need to inform a patient of a particular risk, there will be two separate matters that require consideration:

Why is consent in labour so difficult?

So, why is it difficult to ensure women receive full information about pros/cons, risks/benefits of interventions that might be anticipated to occur in labour? Preferably before labour but at least in adequate detail when intervention is required. Surely there are standards of antenatal education?

The Queensland guideline on content to be included in antenatal education programs even quotes a coroner advocating for improved antenatal education:

“In 2011, following an investigation, the Queensland Coroner set out the following recommendation ‘All women should have access to balanced antenatal information and classes clearly outlining normal and abnormal labour, when intervention may be required and why it may be necessary’ (Queensland Office of the State Coroner 2011). In addition to this, the Coroner stated that risk of interventions and the risk of not accepting the interventions be discussed in classes. Furthermore, that the circumstances of the attendance of each medical professional during labour and birth be discussed and that classes be facilitated by both midwives and obstetricians (Queensland Office of the State Coroner 2011).”

However, it is then relegated to individual antenatal appointment visits because:

“There is some evidence that criticises a risk-based approach to the provision of information for women in the antenatal period which may provoke unnecessary fear for large proportions of women (Hanson et al. 2009). In addition, the potential ‘nocebo’ effect of antenatal education programs has been raised (Hotelling 2013). The nocebo effect refers to the negative impact that the provision of negative information or risk based discussion can have on women’s experiences.”

My experience is that avoiding broad education provision creates a vacuum, and women are ill-equipped to make decisions directly affecting themselves and their babies.

Antenatal education is a space that’s largely midwifery-led, and the Australian group CAPEA (Childbirth and Parenting Educators of Australia) produces standards; however, no obstetric organisations or obstetricians were consulted in preparing the standards.

Surely hospitals have a responsibility?

Yes, all Australian hospitals must be accredited to open their door for business, and the Accreditor is the Australian Council on Healthcare Standards (ACHS). ACHS visits all healthcare facilities as scheduled or ad hoc at short notice. ACHS ensure facilities reach the Australian Commission on Safety and Quality in Health Care standards, and the ‘Third and Fourth Degree Perineal Tears Clinical Care Standard’, published in April 2021, states that organisations should:

By the third trimester, discuss the potential for a third or fourth degree perineal tear

• Discuss the following points together with the woman:
• The fact that perineal tears are common and most heal well without complications
• The fact that third or fourth degree tears are less common (around 3% of all women who give birth vaginally and 5% of first vaginal births)
• Relevant risk factors for the individual woman, including her obstetric history (see Table 1), noting that it is not possible to predict who will have a third or fourth degree perineal tear
• What can be done to reduce risk according to current evidence
• The possible use of induction of labour, epidural analgesia, instruments, episiotomy and an unplanned caesarean section, and their risks and benefits
• The woman’s preference for how she would like to give birth
• Assessment and examination to expect after the birth
• How a third or fourth degree perineal tear will be treated if it does occur, and what can be done to assist recovery and improve outcomes (noting that many woman do not have faecal incontinence).

Clinicians should discuss with the woman the evidence regarding the risk profiles for both forceps and vacuum-assisted birth, as well as the benefits and risks of an unplanned caesarean section.

For health service organisations Ensure that policies, procedures and protocols include the management of instrumental vaginal birth, discussion with the woman about the possible benefits and risks associated with the available options and informed consent.

Ensure that conditions for a safe instrumental vaginal birth, as described in relevant clinical guidelines, are met within the facility, particularly with regard to availability of senior staff, facilities and back-up plans in case an instrumental birth is not successful.

Ensure that clinicians are appropriately trained and experienced to provide safe, high-quality care during an instrumental vaginal birth in accordance with professional standards, and are working within their scope of clinical practice. Ensure junior staff who do not have the requisite skills are supported by an experienced clinician.

So what now?

We know that women need more information about childbirth interventions - the absence of information leads to birth trauma, and information provision has the potential to mediate the effects of traumatic childbirth experiences. I haven’t included references for that statement here because that’s an article of its own.

Obstetricians must provide antenatal information or collaborate with organisations, who should now feel the imperative to improve in this space.

When we meet Tahlia at 2 am, we have a brief time to understand which material risks are priorities for her, discuss the pros/cons and risks/benefits and collaborate with her to reach a solution for her predicament.

What if there has been no antenatal information about vacuum, forceps, and the option of second-stage caesarean section? Can an obstetrician be expected to provide informed consent?

Aside from the scenario of, for example, immediately life-threatening fetal bradycardia, where time is extremely short, and only a broad conversation may be possible, there is an expectation that a fulsome conversation will take place. This can be done in a few minutes. In Medical Board of Australia and Basu, 2018, a tribunal noted:

"The Tribunal prefers Professor Quinlivan's evidence. Dr Basu should have followed the particular approach detailed by Professor Quinlivan. He failed to do so. In particular, Dr Basu failed to explain to the Patient the vacuum extraction method that he proposed to perform; failed to advice the Patient of alternative procedures including a trial of assisted vaginal delivery in theatre and failed to obtain the Patient's informed consent to vacuum extraction before undertaking the procedure.

The Basu case demonstrates the standard of care relating to consent in labour. The Medical Board's expert described how they would obtain consent in the particular scenario at hand.

We train obstetricians for emergencies using simulation, but that training is separate from consent teaching. The two must be done together, and training organisations and supervisors must provide registrars with scripts that cover the available medical evidence accurately, to an appropriate detail, and in a non-directional manner. This can be done!

Summary

• There is a clear imperative for providing accurate, digestible information about interventions that might be expected to occur for women during the antenatal period.
• Caesarean section is a viable alternative to instrumental birth when the baby is mid-pelvis, but some unique risks/benefits need to be shared with the mother (another separate post).
• Provision of information and choice has the opportunity to mediate the psychological harms associated with obstetric interventions and complications (more on that later).
• Informed consent must go into an appropriate depth and include the well-documented aspects outlined above.

Happy to hear your thoughts!

Cheers for now, Danny