None of us would argue that we know everything there is to know about obstetrics. We have not solved all the problems nor optimised the existing solutions already. There is still more to discover and many more ways to improve outcomes for women, pregnant people, babies, and their families. Some recent examples of innovation in obstetrics include advances in wearables for fetal monitoring, the use of artificial intelligence for imaging and cardiotocography interpretation, and novel devices for the management of postpartum haemorrhage.¹ There are other innovations still in the preclinical stage, including artificial placentas or extracorporeal fetal support technology.²

Innovation in medicine and surgery is not new, nor is it new to obstetrics. Pregnancy, labour, and birth have been made safer through the introduction of novel technologies and treatments that we now take for granted. At one time, ultrasound and cardiotocography were new to fetal assessment and monitoring.³ Almost everything we do began as innovations. For example, fetoscopic laser surgery changed the survival for monochorionic-diamniotic twins affected by twin-to-twin transfusion syndrome in the late 1980s.⁴ This procedure is an example of successful obstetric innovation, but there are others that have not proven to be effective or better than established alternatives. Pelvimetry as a tool for predicting obstructed labour has been abandoned because it has been shown to be ineffective.⁵ Sadly, some obstetric innovations have had devastating outcomes. The translation of thalidomide, originally used as a sedative, into obstetric practice to treat morning sickness resulted in limb deformities and a range of other medical comorbidities for those babies.⁶

These examples highlight several ethical issues relevant to medical innovation generally, but also the ethical issues that set obstetric innovation apart from other settings. Responsible innovation should be the aim. It requires stepping through the clinical reasoning about an innovative practice systematically and in ways that align with our legal and professional obligations. While responsible innovation is possible, it is also challenging. The landscape of obstetrics is a particular challenge for innovation. There is a risk that the advances in obstetrics that we need, and that our patients deserve, will be unnecessarily slow to arrive without greater clarity about how to do it well and investment in women’s health research and development.

Responsible Innovation in Clinical Practice

Innovation is a departure from established practice that is novel and done with the intention to improve outcomes for patients. Innovation in healthcare is a varied group of activities that arrive in clinical practice in different ways. Sometimes, it is through research, as for uterine transplant, but not always. While innovation is not the same as research, they often overlap. Sometimes, innovation arrives as the result of clinical problem-solving for an individual case. Sometimes, an unintended outcome is noticed; as was the case for uterine artery embolization. The characteristic feature of innovation is novelty or newness,⁷ and this means that it is inherently risky because less is known. It is the uncertainty about outcomes that drives many of the ethical issues related to innovative practice, from assessing benefit and risk to informed consent.

To begin, doctors have obligations to practice according to an accepted standard. That standard is to exercise reasonable care and skill in the course of providing professional advice and treatment.⁸ The standard is determined by peer professional practice; the evidence for this will come from medical expert opinion and clinical evidence. Evidence of a peer professional practice for an innovative practice may be limited in early phases of innovation, and research takes time to accumulate. This means that innovative practice is a vulnerable space for practitioners, and step-by-step guidance about how to navigate innovation is lacking.

All clinical decisions must be justified and aligned with legal and professional obligations. Any treatment offered must have a reasonable expectation of benefit,⁹ including innovative treatments. That potential benefit is weighed against the known or predictable risks from the available literature – whether to proceed with the innovation, and how it should be tailored to that risk analysis and aligned with legal and professional obligations. Finally, however an innovation begins, research and evaluation must always follow. The ultimate goal for any innovative practice is to eventually become an established one, a feat it will not achieve without supporting evidence.

Innovation in Obstetric Practice

Innovation in obstetric practice attracts the same ethical issues as in other areas of clinical practice. Obstetrics, however, faces some unique ethical challenges because there is a fetus to consider. The presence of the fetus significantly alters the risk and benefit assessment for innovative practice. This directly impacts the feasibility of innovation in obstetrics. There are also challenges to shared decision-making and including the voice of pregnant people when innovating in obstetrics.

1. Is All Obstetric Innovation High-risk?

Innovation is inherently risky, but not all risks are the same. Some risks are acceptable because they are remote or rare, because they have minimal impact or are temporary, or because the benefits sufficiently outweigh them. Risks from innovation may be less well-characterised and estimated because there is less evidence, less experience, and a shorter history to understand the long-term outcomes. Nevertheless, there are some innovations that can be assessed as low risk; repurposing the foley catheter for cervical ripening is an example of this.¹⁰ The presence of the fetus may mean that all obstetric innovations are presumed to be high-risk and that has implications for the feasibility of innovation.

The stakes are high for the fetus if it suffers harm in utero. They are intimately connected to the mother or pregnant person – sharing physical space, nutrients, oxygen – and are wholly dependent on them to survive and thrive. They are vulnerable due to their dependence and their development and rapid growth. An event that causes harm during this time has the potential for significant morbidity or mortality. Finally, the potential impact is for their whole life and the life of their family. Past errors have rightly made us cautious. Thalidomide has taught us that seemingly innocuous treatments in pregnancy, even as little as a single dose, can have lasting and life-changing effects for the child and their family.⁶

Perceived risk to the fetus is one reason that pregnancy and potential pregnancy is an exclusion from research.¹¹ Precaution in the face of uncertain but potentially serious fetal harm has been the position adopted in healthcare and research.¹² While a “better safe than sorry” approach is understandable, it is also harmful. Firstly, it assumes that fetal interests are paramount and outweigh interests of the mother or pregnant person. Secondly, it hinders research and innovation that might directly or indirectly improve fetal outcomes. A more nuanced approach to assessing risk in pregnancy has been suggested so that “pregnant” does not immediately trigger extreme precaution and exclusion.¹² Adopting a similar approach for obstetric innovation is needed so that obstetrics is not left behind.

2. Balancing Competing Interests for Two Patients

Importantly, while the potential for significant harm during this critical time in utero is great, so is the potential for significant benefit. Fetoscopic laser therapy for twin-to-twin transfusion syndrome improves survival of one or both twins and neurologic outcomes.¹³ Fetal myelomeningocoele repair has been able to reduce the frequency and severity of Arnold Chiari II malformations, reduce ventriculoperitoneal shunt placements, and improve motor and urologic outcomes.¹⁴ These interventions, done for the benefit of fetus, can cause harm to the pregnant person. The conflict between interests is another challenge faced in obstetric innovation.

There are two patients to consider in obstetrics, which complicates the process of assessing and weighing risks and benefits. Therapeutic decision-making involves weighing and balancing a range of considerations – clinical evidence, uncertainty about the application of the evidence, patient preferences, broader social and cultural context, resources. These are not necessarily additive or even quantifiable, making the task challenging in circumstances where there is one patient. In obstetrics the challenge is amplified.

Maternal and pregnant persons’ interests may align with fetal interests, but they are not the same. Interests are objective goods that promote an individual’s wellbeing.¹⁵ Basic interests are those needed for basic wellbeing. Ulterior interests reflect a person’s goals and aspirations. In fetal myelomeningocoele repair, the pregnant person bears significant risk for the benefit of the fetus. The fetal interest here is to live a less impaired life. This might align with the pregnant person’s interest to have a healthy child, but they are clearly different.

In other areas of clinical practice, an intervention where there is high risk but minimal or no benefit cannot be recommended. For fetal surgery and fetoscopic laser therapy, considering only the position of the pregnant person, the intervention is not justifiable. Taking fetal benefit into account, however, seems to alter the risk-benefit analysis in favour of providing the intervention. One way of justifying action is to argue that the fetus has interests and status and so should be considered independently of the pregnant person’s interests. Another way is to argue that fetal wellbeing is a maternal or pregnant person interest. That interest could be characterised as an interest in parenthood, or in a healthy child. But not all interests are equal, and some are merely “strong wants”.¹⁵

It is possible that a desire for parenthood or having a healthy child may not be enough to justify the risk of obstetric innovation. While doctors should not provide treatments that are high-risk and do not have a reasonable expectation of benefit, this is a scenario where quality conversations and shared decision-making are essential. Meeting legal and professional obligations when the risk is borne for another’s benefit requires providing balanced and clear information.

3. Expectations Placed on the Pregnant Person

Counselling about innovation in obstetrics requires full information that accounts for a complex risk-benefit analysis and is sensitive to the excessive responsibility sometimes placed on pregnant people and mothers. There are certain assumptions about motherhood and maternal behaviour related to the fetus.¹⁶ This can place excessive responsibility on the mother or pregnant person to make decisions in the interest of the fetus, rather than in their own. This can limit the ability to voice preferences, thoughts, and feelings, and has the potential to dehumanise pregnant people. It can also produce unbalanced counselling by minimising the depth of discussion about options that are not in the fetal interest. Unbalanced counselling puts patient autonomy at risk.

Informed consent about innovative treatments requires more information, not less, to meet legal and professional obligations. The obligations for pre-treatment counselling are not different between established and innovative treatments, nor are they different in obstetrics compared to other settings. However, what is required to meet those obligations will be different because the context and complexity is different. Patients should be told when a proposed treatment is innovative and what the risks and benefits are, including what is not known. Patients should be told about the established alternatives and offered a comparison of risks and benefits with the proposed novel treatment. Patients should be told about conflicts of interest, offered a second opinion, given written information, and allowed a cooling-off period to consider and return with their questions.

For obstetric innovation, patients should be told about the risks and when they will not benefit from the intervention themselves. They should be offered options to act in their own interests alongside other options, without bias or direction.

4. Failing to Hear and Respond to Patients

The integration of the patient voice has been a challenge to innovation across medicine and surgery. Clinicians are well-placed to identify problems and innovative solutions. However, the clinician-identified problem may not align with patient priorities and clinician-identified solutions may not be acceptable to patients. Involving patient experiences in the process from the beginning is one way to deliver patient-centred design and the development of meaningful options for care.

Listening to patients when innovation goes wrong has also been a recurring problem. Both thalidomide and vaginal mesh are examples of delayed response to patients’ concerns and reports of adverse outcomes. The harms reported were compounded by the harm of being dismissed. For all innovation, it is important to provide clear pathways for patients to raise concerns. More than that, it is important that those concerns are validated and acted on.

Conclusion

The best that we can achieve in obstetrics is still to come. Our patients and their babies are relying on us to find new solutions and to keep working towards better. While obstetrics presents some challenges, these can be largely overcome by understanding our obligations, good clinical reasoning, shared decision-making, and partnering with patients at every step of the innovation journey.

RANZCOG members can self-claim CPD hours under the CAPE requirement “Ethical Practice” for reading this article.