By Dr Victoria Adkins, published 1st August 2024 

What role could and should caution play as artificial placenta technology continues to develop? In this blog, our Visiting Collaborator, Dr Victoria Adkins, outlines the current status of research into artificial placentas and reflects upon some of the issues raised by taking a cautionary approach to the introduction of this technology.

Existing limitations on neonatal intensive care have been the impetus behind the recent surge in interest in the development of artificial placentas. Artificial placenta technology, also referred to as artificial womb technology and more recently artificial amnion and placenta technology, mimics the conditions of the human placenta and is currently being developed in order to improve outcomes for extremely premature infants.

Premature babies are now shown to survive after being born at gestational ages as low as 22 weeks. However, this survival is often combined with a range of co-morbidities that not only result from the fact of prematurity, but are compounded by the intensive nature of current practices in neonatal intensive care.

Premature infants often lack sufficient lung-development to allow them to breathe unaided and therefore require ventilation or other forms of invasive treatment. In a bid not only to secure the survival of infants born at such early gestational ages, but also to reduce the associated co-morbidities, artificial placentas have been developed to allow extremely premature infants to continue to gestate to term. In such an environment the lungs can continue to grow and mature as gas exchange occurs via the umbilical cord and an oxygenator pump.

Artificial placentas have not yet been introduced into clinical practice. However, animal studies with lambs conducted by teams in the U.S. and Australia and Japan have indicated success, and a seminar has already been conducted with the US Food and Drug Administration to discuss the safety and efficiency of the technology, with a view to moving towards human clinical trials.

In my PhD study, which engaged with healthcare professionals who work closely with pregnant individuals and fetuses, caution was a central theme in my analysis. Caution was demonstrated by participants in their display of hesitancy towards the technology and in their need to be clear about its purpose prior to application in clinical practice. In particular, they wanted to avoid poor or detrimental outcomes for the fetus or resulting child.

Caution is, therefore, characterised as an awareness of consequences but also the behaviours, often slow and attentive, in our approach to something new. Taking a cautious approach towards a new technology, particularly one that is yet to have been proven successful in human clinical trials, is not necessarily surprising, and forthcoming publications from my PhD will further outline the impetus behind the cautious approach of my particular participant pool.

However, whilst it was clear from my participants that caution does play a role in the development of artificial placenta technology, the question remains as to whether this should be the case and, if so, to what extent.

What role should caution play?

It is clear that caution should play some role as artificial placenta technology develops as it would be reckless not to give due regard to the potential of poor outcomes for the resulting child, particularly as the very purpose of the technology is to improve survival and morbidity rates. To ignore concerns surrounding child welfare would be to place too much emphasis on innovation and speed without recognition of why the technology itself is being developed. Caution can, therefore, play a role in limiting the application of artificial placenta technology particularly in the first instances of its application to ensure the technology is not being utilised simply because it can.

It is also important to recognise that caution is not necessarily a neutral concept. It can be co-opted as both a tool to argue against the technology, particularly given uncertainty around its outcomes, but also to caution against uncertain futures if we do not advance existing neonatal care. Different stakeholders in the technology will have different ideas as to what risks should be cautioned against, so the concept will not hold a universal or objective meaning for those involved in its implementation.

In addition, caution need not only be apparent when discussing the welfare of the child. A broader application may cause us to question, for example, whether we should be cautious that the development of artificial placenta technology may divert resources away from other types of care and whether the resources required outweigh the benefits.

When should we be cautious?

The time at which we apply caution also requires further thought: what consequences should we be alert to? At which stage of the development? And how should this alter our approach towards the technology? As a clinical trial with human participants has not yet been undertaken with artificial placenta technology, there will be different instances in time when caution needs to be applied, and this may also influence whose needs should be taken into consideration at any given point.

In terms of balancing competing needs, once the developing entity is placed in the artificial placenta device, it is their health needs that become the priority. When deciding the point at which an artificial placenta should be used, however, priority may be better placed with the health of the pregnant individual as they would need to undergo invasive treatment for the fetus to be transfered to an artificial placenta.

The needs of the pregnant individual should also not necessarily be limited to health needs, but should include a consideration of their wider circumstances such as prior difficulties they may have faced in becoming pregnant and any disruption they may feel in the attachment to their fetus. The balancing of competing needs should be dealt with on a case-by-case basis as opposed to a blanket approach for all.

Who decides?

Who should decide how much caution or risk is acceptable when applying artificial placenta technology in any given case, including during clinical trials? Authority over such decisions should arguably not lie with any particular individual or group. Rather, consultation is needed across diverse stakeholder groups including policy makers, potential users of the technology, clinicians and regulators. It may also be the case that an external body or ethics committee with wide representation should deal with cases as they arise.

It is also important to consider the idea of national and/or international agreement, which may be developed as use of the technology increases in local cases. This is likely to lead to shared learning and development of well-informed best practice guidelines. Information provision is also crucial, particularly for non-specialists and lay audiences, in order to enable them to participate effectively in any consultation regarding the introduction and use of the technology.

I have discussed elsewhere how education campaigns may be an effective way of informing the public about the technology before its implementation. However, this needs to be weighed against the resources that would be required to deliver this and whether such wide dissemination is necessary when only a very small proportion of the public may find themselves in need of the technology.

Is the issue of caution unique to artificial placenta technology?

It is important to note that the issue of caution, raised by artificial placenta technology, does not necessarily differ to that raised by other new biotechnologies. Could it then be that the development of artificial placenta technology will simply be a catalyst for us to review how we regulate innovative medical treatment rather than to dissect the technology itself?

An argument that ectogestation should be used as a provocative tool to consider current contexts is already live within the literature. However, arguments have also been advanced to suggest that artificial placentas constitute more than a mere extension of current neonatal care and therefore should be deemed as medical research requiring clinical trials. While those clinical trials may be subject to the same ethical and legal parameters as those that have gone before, the question remains whether this specific technology requires closer scrutiny, and if so, why?

Dr Victoria Adkins is a Lecturer in Law at University of Greenwich, and has recently completed her PhD at Royal Holloway, University of London. She would like to thank members of The Future of Human Reproduction team who contributed to a workshop discussion that led to this blog.