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Neil Marlow, Professor of Neonatal Medicine at University College London and Principle Investigator on the ‘EPICure’ follow-up studies of premature babiesÌý

Susan Bewley, Professor of Complex Obstetrics at Kings College

Deborah Bowman, our programme stalwart, who is Honorary Professor of Ethics and Law at St George’s University of London

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I recently listened to your episode on growth restriction in pregnancy. As someone who has experienced a growth restricted pregnancy, (very similar to the first case study in the episode), I thought it conveyed the difficult ethical decisions that parents and clinicians have to make. It also made me appreciate the size of some of the decisions that we were having to make, which you don't necessarily appreciate when you are living through it.

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While I am delighted that both the case studies resulted in the babies leaving hospital, I think the discussions would have benefited from a case study which didn't have such an outcome. While the episode touched on the decisions around removing care, which I believe is the biggest decision parents and clinicians will make in this situation, I really think it would have helped the discussions if there had been the viewpoint of people who had made that decision, and whose baby subsequently died. I do appreciate you have explored some similar issues in your episode on organ donation and new-born babies (which I also thought was excellent) but that had a different dimension.

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More broadly, there is a real issue with people presuming that once a baby has been delivered alive, that they will survive, which we sadly know isn't always the case. In fact, it is so common that our Consultant Neonatologist said that a big part of her job is ensuring that a child's death is a 'good one'.Ìý However, this misconception can result in a real sense of isolation for those who lose a baby in a neo-natal setting.

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Just to give you some context to my feedback, we started to have problems at approximately 15 weeks, with severe IUGR diagnosed following the 20 week scan. Just like the first case study, we had to make a decision about whether to continue the pregnancy, and it became a case of waiting for as long as possible, before we had to deliver him. We actually got further than both the case studies, with our son, Aneurin Fred Owens born at 30 weeks on 24 April 2012. He weighed 550g (1lb 2oz). Our Fetal Medicine and Neonatal Teams did everything that they could, but sadly Aneurin was just too small and died four days later on 27 April 2012. He had as good as a death as we could have hoped, in our arms, hearing only words of love as he died. I think the importance of a good death is really very important, and I think that the ethical dimension of this when making the decision to remove care was lost by not hearing that sort of experience.

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I would like to be clear, that this isn't in any way a complaint, but I wanted to share my perspective on the episode. I would like to say a big thank you for exploring these issues with such delicacy and care. Growth restriction in pregnancy seems to be something that no-one talks about, so it is fantastic to hear your programme talking about it.

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I do want to emphasise that I think it was an excellent episode and I have urged family and friends to listen to it, to help give them some insight into some of the difficult decisions we had to make.

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Once again, with many thanks for exploring growth restriction in pregnancy with sensitivity and empathy.

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(Naomi Stocks)

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I would like to hear about the subsequent lives of people who have been kept alive against all the odds at birth and about the difficulties they face. (I have to apologize if a programme about this has been broadcast and I missed it.) I suggest there is a moral or ethical dilemma about using resources to prolong the life of someone who is likely to be physically or mentally crippled rather than, for example, trying to get the criminal justice system to work in cases of, say, child sexual abuse. Perhaps the overall dilemma is whether to strive at all costs to bring even more people into an already overpopulated country or to do our best to look after the ones who are already here.

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(Robert Hinton)

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Hi, Just to say this programme is inspiring, radio at its very best. Well done to all involved in making this, it makes one realise that in this day and age, we still have questions that sometimes have no answers, especially when it comes to human life.ÌýÌý

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It would be good to take this further and present a whole series on ethical dilemmas in general and how they differ across the globe. The political, cultural and moral issues could help us understand international differences and our common ground towards ethical answers.

Thanks for all the programmes

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(Maggie Lambert)

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Hello, I listened earlier to your programme featuring the two very premature babies.

I thought it was a good analysis of the difficult decisions that had to be made.

However, two thoughts:

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Both the babies survived and did not seem to suffer with major disabilities.

This does not remotely fit with the stats given by the medics.

Your programme would leave the listener with a massively biased view of the likely outcome.

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Secondly, what about the ethics of taking away resources for this?

Are health care resources limited?Ìý Of course, yes.

So within that overall limit, should there be a limit on resources going to very premature babies?

Consider that while those babies were in long term intensive care - another child or adult may have needed that resource, which was as a result unavailable.

That child or adult has hopes and dreams, and long established relationships with others.

The babies did not.

There’s the big ethical question , surely?

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(Richard Clark, Windsor)

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THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT.Ìý BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE ´óÏó´«Ã½ CANNOT VOUCH FOR ITS COMPLETE ACCURACY.

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INSIDE THE ETHICS COMMITTEE

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Programme 2 – Growth Restriction in Pregnancy

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TX:Ìý 11.08.16

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PRESENTER:Ìý JOAN BAKEWELL

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PRODUCER:Ìý BETH EASTWOOD

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Bakewell

Today pregnancy brings not only family happiness but a whole battery of tests and scans to check on the baby’s development: it’s very reassuring.ÌýÌý But what happens when tests discover that the foetus isn’t growing and there’s no available treatment: at that point parents face difficult dilemmas.

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Welcome to Inside the Ethics Committee.

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It’s the beginning of 2015. Clare and her partner Steve have been together for several years.Ìý They’re about to set up home and have been thinking about having a baby for some time.

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Clare

We were sort of umming and ahhing whether to or not because my daughter’s nearly 18 and I didn’t know whether I wanted to go through the whole thing again.Ìý So we sort of said let’s see, if it happens it happens.Ìý Anyway it did and we were very happy and so was my daughter, she was over the moon as well to know that she was going to have a little brother or sister.

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Bakewell

All goes to plan at the start.Ìý Clare has no morning sickness and the 12 week scan shows the pregnancy is going well.Ìý But by week 20, there’s a problem. Scans show that the baby is smaller than expected.Ìý Clare is sent to a specialist hospital where an obstetrician scans again and confirms this is so.Ìý He also looks at the blood flow between Clare, the baby and the placenta to see if it might be the cause.

Obstetrician

The placenta is an absolutely critical organ in terms of foetal wellbeing.Ìý It receives blood from the mother, which carries nutrients and oxygen to the baby’s blood.Ìý So problems either with the blood flow from the mother to the placenta, with the placental structure itself or with the baby’s blood flow to the placenta could all lead to an insufficient supply and therefore the baby wouldn’t grow.Ìý In Clare’s case it was a good bet that the problem with foetal growth related to a problem with the placenta or its blood supply.

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Bakewell

Foetal growth restriction can be caused by an infection or a chromosome abnormality in the foetus, but tests rule this out.Ìý And even if the problem is caused by a poor blood supply, there’s little the doctors can do to help.

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Obstetrician

There are no proven treatments for this condition to improve growth.Ìý So really the only options, when a baby is – you couldn’t deliver it because it’s so small – are to continue with the pregnancy and monitor the baby’s growth or parents might choose to have a termination of pregnancy.

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Bakewell

But Clare doesn’t want to terminate, and she’s relieved that continuing with the pregnancy, in the hope that the baby will grow, is an option.

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Clare

The fact that he was willing to see us each week and watch how he grew, although everything wasn’t great it was quite comforting.

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Bakewell

For the next five weeks, the scans show that the foetus is growing.Ìý It’s at a slower rate than the obstetrician would like, but it’s progress.Ìý A week later, however, when Clare is 26 weeks pregnant, he’s more concerned.

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Clare

I knew that something wasn’t great about this appointment because usually he would come straight in and give us his way but on this day he was doing more measurements and I just felt that something was a bit different.

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Bakewell

The scan now reveals that the growth of Clare’s foetus has stopped entirely.Ìý The blood flow to the placenta has deteriorated and the baby is struggling.

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Obstetrician

If a baby isn’t getting enough oxygen and glucose blood gets preferentially streamed so that the heart keeps functioning and also to the brain, so that the brain keeps growing and then less blood goes to other bits like the muscles, which is why the baby doesn’t grow.Ìý So you can look at the blood flow to the brain and you can say has that increased and we could see that in Clare’s foetus.

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Clare

It’s very hard to think that gone through the whole 26 weeks feeling absolutely fine, so I felt guilty that it was my fault that he was so small.

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Bakewell

The team is worried that leaving Clare’s baby in the womb could threaten its survival. On the other hand, delivering such a tiny baby at just over 26 weeks, is also fraught with risk. The obstetrician estimates its weight to be 493 grams.Ìý

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Obstetrician

Less than 500 grams is really, really small and it’s right on the verge of the size of baby that we can actually keep alive.Ìý And 26½ weeks gestation is also incredibly early.Ìý So on the one hand you’ve got an option of delivery but on the other you’ve got the option of not delivering the baby in the understanding that the natural history, if you like, would be for the baby to die in the womb.

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Steve

I found the decision really hard but I personally felt at the time, as hard as it was, it would have been better to let nature take its course.

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Bakewell

Clare’s partner, Steve, who works in the country farming sheep.

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Steve

I’m very sort of involved in the natural world and whereas I don’t want it to sound cold-hearted if something’s not meant to survive in this world then I find it hard to see why it should be put through that because we knew it was going to be a very slim chance that it would even survive the delivery and I was scared for any long lasting effects that they told us the baby could suffer.

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Clare

It was so difficult because you sort of think if you’ve got a heavily disabled child are you going to be able to cope.Ìý Also he might just die inside of me.Ìý It was quite difficult to imagine doing and it was basically our decision which way we were going to take it.

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Steve

And couldn’t help thinking about years to come, whatever decision we went with, either the grief and the possible regret or living with a very unwell or possibly quite challenged child.

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Bakewell

And if they decide to deliver the baby, the best moment to do that is difficult to determine.

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Obstetrician

There is some uncertainty about that.Ìý It must be very concerning to think that you’re looked after by doctors who perhaps don’t know what they’re doing.Ìý That’s not the case, it’s just our best judgement and I think people have to realise the limitations sometimes of that.

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Bakewell

Joining me today to discuss the ethical issues raised are:Ìý Neil Marlow, Professor of Neonatal Medicine at University College London and Principal Investigator on the ‘EPICure’ follow-up studies of premature babies and Susan Bewley, Professor of Complex Obstetrics at Kings College London.Ìý

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Now we know that Clare’s just over 26 weeks pregnant and her baby weighs just 493 grams. ÌýWhat do we know about the probability of a baby like that surviving in this situation?

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Marlow

At 26 weeks around 85 to 90% of babies will survive.Ìý But this baby has failed to grow and that would reduce the rate of survival to around 30 to 50%.

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Bakewell

And of those survivors what chances are there of such a baby having some form of developmental disability?

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Marlow

If one looks at the group that are growth restricted then at 26 weeks about 10% are likely to have cerebral palsy.Ìý The bigger group are those who have rather slow learning as they grow up and that is much more difficult to estimate because there are very few good studies of babies who have been severely growth restricted.

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Bakewell

Susan Bewley, let me ask you this, the baby is said to be 493 grams, how is that measured?

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Bewley

When we scan babies in the womb we’d measure their head circumference, like their hat size; their leg length, the top bone of the leg and their waist.Ìý What’s happening in growth restriction is that the baby has got a smaller waist and a bigger head, because the blood is being diverted to the brain but the scanning is actually an estimate.Ìý So we are at least 10% on either side – this baby may be as little as 450, it may be as much as 550.

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Bakewell

What is the standard weight of a baby at 26 weeks?

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Bewley

Seven hundred and fifty, maybe as much as a kilogram.

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Bakewell

So falling very far short.

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Bewley

It’s very far short.

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Bakewell

Now Neil, one option that is open to Clare and Steve is to have their baby delivered in the hope that it will survive but how do you predict the best time for that delivery?

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Marlow

You look at the growth rate; we look at the heart rate which becomes much less variable as the baby becomes sicker; we look at the blood flow and the great thing about the last study we did was that the trade-off was very, very clear, if you left them as long as you could you had a small excess of babies that died in the womb and we had a relatively minimal number of babies who had severe disabilities at two years of age.

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Bakewell

How do you counsel parents about making the decision they have to make when the outcome is so uncertain?Ìý Susan.

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Bewley

It’s very difficult, we have to, as doctors, use our expertise and knowledge to say if we do nothing we think this will happen.Ìý If we go on as long as possible until the baby is very close to death we will get further and we have a little bit better of survival.Ìý But the trade-off is that you’re risking death in the womb and you’re risking damage before even the birth happens.

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Bakewell

Neil, these are quite sophisticated nuances of decision making, how can you put that across to parents and advise them?

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Marlow

I think it’s very difficult because most of the data that we see is based around populations.Ìý Now the obstetric view is often much more pessimistic than the neonatal view and I don’t know who’s right but I think one has to find out how the parents are interpreting the sort of data you give them, to understand how we can help them to make the right decision for themselves.

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Bakewell

Now the other option is to continue with the pregnancy in the knowledge that the baby will surely die in the womb.Ìý Do couples opt for that Susan?

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Bewley

Some people will say let’s leave it to nature, let’s leave it to God.Ìý If we get to 28 weeks I’ll give it a go.Ìý So we have negotiations that change even as we’re observing.

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Bakewell

Slightly different question this:Ìý does the foetus have any rights to life?

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Marlow

That’s really difficult and it’s something that we spent a lot of time talking about when we reviewed this area with the Nuffield Council on Bioethics about 10 years ago now.Ìý Legally the foetus has really no rights until it’s born.Ìý But from a sort of moral and ethical perspective there’s a gradual emergence of a foetus into something that’s going to become a baby and it becomes very difficult for a woman to take a hard edged view of the legality of it.

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Bakewell

Susan?

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Bewley

Most pregnant women operate very much with their baby’s best interest at heart and pregnant women, on the whole, are very altruistic.Ìý And I think the legal situation works to get excellent conversations between obstetricians and paediatricians and parents all working in the same direction.

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Bakewell

Right well let’s go back to this real-life case.Ìý Clare and Steve’s baby has stopped growing and they have to decide whether to agree to the delivery of their tiny baby, or continue with the pregnancy in the knowledge that the baby will die in the womb.Ìý They recall making that decision:

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Clare

We sat in a room on our own making a decision but I’d already made my mind up because there was no way I was running the risk of losing him inside of me, I’d rather us being able to be with him rather than not at all.

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Steve

There was sort of like a nervous excitement when it finally came round.Ìý We were so wound up and tense.

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Clare

Was he going to be okay and was this still the right decision that we’ve made.

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Bakewell

The following day, Clare is admitted to hospital. Two days later, when a full medical team has been mobilised, the caesarean goes ahead.

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Clare is given an epidural so she can be awake throughout the operation, her partner at her side.Ìý As the baby is so small, she’s having what’s called a classical caesarean.Ìý This involves making a big vertical incision which gives the obstetrician greater access so the baby can be lifted out of the womb as gently as possible.Ìý The obstetrician overseeing the delivery.

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Obstetrician

We delivered Samuel in the membranes, this protects the baby from unnecessary bruising or any unnecessary trauma at delivery.Ìý And then broke the membranes and put him in a little plastic bag, which keeps him warm, and passed him straight to the paediatrician.

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Steve

I didn’t even try and look, don’t think I started crying, but I was shaken a bit and feeling very nervous.

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Clare

We still didn’t know whether it was a boy or a girl or was he breathing, so yeah it was quite daunting.

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Bakewell

The baby, a boy, has a faint heartbeat at birth and is resuscitated and put on a ventilator.ÌýÌý

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Clare

They wheeled me down on the bed to see him later on that afternoon.Ìý He was in the incubator.

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Steve

He had cables coming out of everywhere and a little wee hat on his head.Ìý He was smaller than my hand, just minute.

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Clare

His ears hadn’t formed properly, his skin was transparent and I just couldn’t believe that he was here.

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Bakewell

Just hours since the birth, the team is extremely worried about him.Ìý A neonatologist – a specialist in the newly born - talks to Clare and her partner.

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Neonatologist

I explained how every organ in his body had been affected by this poor blood flow prior to birth including his brain.Ìý I said he might not survive the first few days and I asked them if they wanted to have him Christened.

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Clare

Which was obviously very scary.Ìý I don’t think I was quite prepared for the way that he was looking to be honest.Ìý He was so tiny, it’s unbelievable that something so small could be surviving.

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Bakewell

The main problem is his immature lungs.Ìý Over the first few weeks there’s a struggle to get enough oxygen into them. Another member of the team.

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Neonatologist 2

As a result of this we were having to ventilate him harder and harder and where we found ourselves with Samuel is that you can become into a vicious cycle where the ventilator damages the lungs which in turn means you need to ventilate them harder.Ìý And the eventual potential of that is you can get to a stage where it is not actually possible to ventilate a child and at that stage they would die.

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Clare

It’s very worrying because you think well is that one time that’s going to make him go, you know, and him not recover and come back.

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Bakewell

And these invasive procedures the babies have to endure to keep them alive also have to be weighed in the balance.

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Neonatologist 2

That is only a reasonable thing to consider putting a child through if there is a significant chance of not only getting home alive but also going on to have a – as normal as possible childhood.

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Steve

Some of the things they had to do caused him quite a lot of discomfort but if he didn’t have them done he’s not going to progress.Ìý So it was really hard.

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Neonatologist 2

And where that really is not a reasonable expectation there comes a point where questions have to be asked as to whether this is a reasonable thing to put a child through.

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Bakewell

Let’s pause Clare and Steve’s story for a moment, and hear from Rita and her husband Sanjay.Ìý Their baby is also too small but they’re faced with a very different dilemma.

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Rita is 43 and they’ve been trying for a baby for two years.Ìý They’ve had one unsuccessful attempt at IVF so, in early 2014, when the second attempt results in a pregnancy, they are delighted.Ìý

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For the first five months all goes well but, when Rita is almost 24 weeks pregnant, she gets a blinding headache.

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Rita

It was a real sharp pain in the back of my head.Ìý To be fair I didn’t pay too much attention because I suffer from migraine so maybe it was just a form of a migraine.

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Bakewell

But it just gets worse and by midnight the same day they head to the hospital.Ìý Rita’s blood pressure is sky high.Ìý She’s diagnosed with preeclampsia and given medication to try to bring down her blood pressure. A scan of the baby reveals it’s small.Ìý Rita’s husband Sanjay.

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Sanjay

Within about 15-20 minutes there must have been 12 people in the room.Ìý You could see the look on people’s faces – there’s something really, really wrong here.

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Rita

I was just shaking, I could not stop shaking.

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Bakewell

The following day Rita is transferred to a specialist hospital where the obstetrician does a more detailed scan of the foetus.

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Obstetrician

She was just over 24 weeks and at that stage we’d expect a baby to be weighing 6-700 grams and what we were getting was about 450-460 grams.Ìý We were convinced that the placenta wasn’t working well and this was why the baby was so small.

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Sanjay

So you think of something like a bag sugar and that was less than a bag of sugar.

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Obstetrician

I was already thinking of this as a baby that it’s born now is probably not going to survive and here is a mother who quite possibly is going to get a lot more unwell over the coming days.Ìý But also thinking how am I going to explain all of this to these parents, who have no idea that this is coming.

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Bakewell

The obstetrician asks everyone else to leave the room so she can talk with Rita and Sanjay privately. Rita’s condition - preeclampsia - is caused by being pregnant.Ìý If it gets worse it could endanger her life.Ìý This means that, for Rita’s sake, the baby will have to be delivered. If this becomes necessary, there are two options.

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Obstetrician

One option would be to try and deliver the baby but at a stage where we know the likelihood of the baby surviving is quite limited and of those that do survive they are more likely to have significant health problems.Ìý So it’s a really dangerous situation for a baby to be born in.

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Sanjay

We were both gobsmacked.

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Rita

Yeah and you think well you can’t deliver her, she’s just tiny, well that’s what we said – look can’t you just keep in and do whatever you can.

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Bakewell

The second option - should the baby have to be delivered for Rita’s health - is to conclude that the baby is too small to survive outside the womb and to take the decision to terminate the pregnancy.Ìý

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Obstetrician

At this stage of pregnancy this is a really difficult procedure to go through because you have to do an injection through the womb to stop the baby’s heartbeat and then give the mother hormone drugs to induce a labour.Ìý So a really difficult dilemma as to which way things should go.

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Bakewell

Rita and her husband Sanjay want everything done to save their baby’s life, so they choose that the baby be delivered.

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However, there are risks to the actual delivery. Not only will Rita have to have a classical caesarean, as Clare had, but the preeclampsia puts her at risk of bleeding during the operation.Ìý She will be put to sleep throughout, so the team can act swiftly if this happens.Ìý

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The chance of the baby surviving has to be carefully balanced against these risks.Ìý

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Rita is admitted so she can be closely monitored. She remains stable over the weekend but, on the Monday afternoon, Rita’s health deteriorates.Ìý Her caesarean is planned for that evening.

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Rita

I think I was too ill to get out of the bed and that’s when the doctor came to see us and explain to us she’s 460, our cut off is 500.

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Neonatologist

I was fairly gloomy in what I said to her.

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Bakewell

The neonatologist on call.

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Neonatologist

We’ve had few survivors below 500 grams and no survivors below 450 grams.Ìý There was a high chance that the baby wouldn’t survive and if her baby did survive the neonatal course is difficult and there is significant chance that she would have long term developmental issues.Ìý And I explained that there was a possibility that it would be technically impossible to resuscitate a baby simply because the baby may be too small for us to get a tube into their airway or do other procedures that would be necessary for us to be able to provide intensive care.

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Rita

Even though it’s not something you wanted to hear they were being honest with us.Ìý My mum was there and she was sitting there praying with me and that, so at that stage I didn’t know what was happening after that stage.

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Sanjay

I think it was coming up to about 9.30 and they were getting you ready weren’t they and that’s when the night consultant came over to find me.

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Neonatologist 2

I met Rita when she was about to have her caesarean section, so she was very unwell and I knew she was going to have a general anaesthetic.

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Bakewell

This neonatologist puts forward a slightly different view.

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Neonatologist 2

Although we feel that 500 grams is a nominal cut-off, in this circumstance I didn’t really want a mother to be put to sleep having no idea whether we were even going to try and offer her baby intensive care.Ìý So I told her, just before she was put to sleep, that we would see if it was possible to resuscitate her.

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Sanjay

And that was just so great to hear.

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Rita

We were just willing for her to be okay.

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Bakewell

Rita and Sanjay are also prepared for the worst.Ìý The obstetrician who’ll be performing her caesarean.

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Obstetrician

We had to talk about risks of an operation, following with the baby might not survive.Ìý Rita would be asleep so when she would wake up her baby might already be dead.Ìý And we discussed with her partner how he would be able to be with the baby immediately after birth.

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Bakewell

Determining whether a baby, once delivered, should be resuscitated is not clear cut. A senior member of the team needs to assess the baby’s maturity and condition.Ìý Then they make the crucial decision as to whether it’s likely to survive, not only in the short, but also in the long term.

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Neonatologist 1

Life is incredibly precious and to not give a child the chance of that is a very weighty decision.Ìý The way we practice is to go and make a subjective judgement, probably on the majority of cases we would agree but sometimes between even individual consultants in this single centre we’ll make slightly different decisions, which means at times probably somebody would attempt to resuscitate a baby who another person wouldn’t because you’re making a subjective judgement about whether you think this baby is going to benefit from intensive care or not.Ìý And that decision we probably don’t always get right but we try as best we can to get it right.

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Bakewell

And, of course, if Rita’s baby is resuscitated it’s impossible to know whether it will thrive in intensive care or not.

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Neonatologist 2

Intensive care for babies is onerous and you can have a multitude of painful procedures, which we would prefer to avoid, so that you do have to weigh up what is bearable for the baby but it doesn’t mean that anyone who’s going to be disabled shouldn’t be offered the chance to survive.

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Sanjay

The life of your partner and your child is actually in their hands.Ìý But the reality was there that nobody knew what was going to happen.

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Bakewell

Joining Susan Bewley and Neil Marlow to discuss these cases is Deborah Bowman, our programme stalwart, who is Honorary Professor of Ethics and Law at St George’s University of London.

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Now Neil before I come to talk ethics with Deborah, let’s deal with the medical side.Ìý When you’re at a delivery of an extremely tiny baby, like Rita’s, who is estimated to weigh only 460 grams, how do you go about deciding whether to resuscitate or not?Ìý

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Marlow

It’s very difficult to make a decision with the baby in front of you because you don’t know how that baby is going to respond to very simple things that you might do, like giving oxygen, like suctioning, like placing a tube into the lungs and inflating the lungs.Ìý And I think most of us, in that situation, would actually default to go ahead with attempting to see if we could stabilise the child after birth.Ìý There are some measures that we might decide not to take with someone who is so small.Ìý For example, if the heart rate does not respond to having the lungs inflated we may not proceed to give drugs and chest compressions, which we do just with two fingers.

Ìý

Bakewell

Deborah, let me bring you in here.Ìý How does this stand in moral terms?

Ìý

Bowman

What one’s thinking about is the best interests of this new person.Ìý That sounds like it’s a one-off judgement but of course it’s not, it’s a moment by moment judgement that’s informed by all the medical information that you’ve got in front of you.Ìý But there’s also something else that I heard that I was very impressed by actually, which was both the moral anticipation of the choices and I wasn’t troubled at all by the difference of opinion between the two doctors who came on, I actually thought their willingness to be honest about the judgement that will be required was both courageous and refreshing.

Ìý

Bakewell

It is more complicated isn’t it.Ìý Do you think women in her situation are able to weigh the risk?Ìý She’s 43, it’s IVF, it might be Rita’s last chance.

Ìý

Bowman

Of course she’s going to be informed by the fact that she wants and loves this baby, but that’s what autonomy’s about.Ìý In purely legal terms, does she have capacity?Ìý Well at the time when she’s making this decision she does.Ìý This is why the idea of the rational autonomous human is so illusory because none of us is like that really.Ìý So actually what we’re trying to do is work with a version of autonomy that shifts, that’s informed by all kinds of things and that’s why clinical ethics is both so interesting but also so hard.

Ìý

Bakewell

What do you make of that Susan?

Ìý

Bewley

I agree there are brain conditions, if she has swelling and fluid on her brainÌý that might make her brain not work in preeclampsia, so we have to be mindful that her capacity could be affected if she’s just about to have a fit, for example.Ìý But that’s why the moral anticipation, the talking about it from the beginning, is very important.

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Bakewell

Right well let’s just revert to the story of Clare and Steve’s baby – Samuel his name is – who has been born and is having to endure lots of invasive procedures to keep him alive.Ìý How can you tell when a baby is suffering?Ìý Neil Marlow.

Ìý

Marlow

When the things that are being done to the baby are causing him some measure of distress.Ìý We offer the baby pain relief at a level where we think that’s likely to be effective.Ìý It’s very difficult because most of the drugs that we use to treat pain in babies don’t work in the same way.Ìý The other side of that question I think is how do we discover whether a baby’s prognosis is altering by what has happened to him.Ìý And that’s a very much more difficult discussion because we have scans which we can do of the brain and we can look for evidence of bleeding into the brain and that’s really the major determinant of something like cerebral palsy.Ìý But the other impairments are much less tangible than that.Ìý Having said that the bulk of children don’t go on to have severe disability and it’s this concept of uncertainty which is really difficult for parents.Ìý And then the baby’s there and the doctors have said – well we can always stop if things are looking bad.Ìý But actually getting the doctor to say are things really bad now, is actually really difficult.

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Bakewell

Well is there a point when you feel that the degree of suffering is intolerable to a point when you should let a baby die?

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Marlow

I think that’s a really difficult question to answer.Ìý And we try to make the judgement not on the acute suffering which we can manage but more on the prognosis, which if you end up with a large bleeding into the brain then we know the outcome is awful.

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Bakewell

Deborah, how do parents engage with these kind of subtleties?

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Bowman

As a parent the wish to understand, there’s never going to be a better motivation to want to get a decision right.Ìý However, there is no doubt that people engage with it very differently.Ìý And of course the priority for the team is to adapt to those different ways of wanting to engage to the ways in which people are understanding but also pace.Ìý And that’s quite difficult when you’ve got to make decisions within a time limited frame. But there is something temporal about this and the pace at which people can and want to make decisions coupled with the pace at which the infant in front of you is needing decisions to be made.

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Bakewell

Well we’re just going to leave Clare and Steve with their baby Samuel for a moment and go back to the second case – Rita, who has preeclampsia.Ìý Now she’s prepared for the delivery of her baby that’s estimated to weigh just 460 grams.Ìý She’s given a general anaesthetic to put her to sleep and the obstetrician performs a classical caesarean.

Ìý

Ostetrician

Babies born at that early gestation they’re really, really tiny, they’re not much bigger than a little kitten.Ìý So you just try to do it as slowly as possible to allow as gentle a delivery as possible.Ìý And then once the baby goes out we rupture the membrane, we put the baby in a small plastic bag so the baby remains warm and after cutting the cord we pass the baby to the neonatologist.

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Neonatologist 2

She was small and she was quiet but her skin didn’t look like jelly, her eyes weren’t fused, so she didn’t have the appearance that some very extremely pre-term babies have who can look really like a foetus rather than a baby.Ìý I decided not to weigh her but to just get on and stabilise her.Ìý So we very quickly got the breathing tube in, gave her her air and she stabilised and got pink and active very quickly.Ìý And then we weighed her afterwards and she really was 460 grams and I thought I’m going to get a bit criticised for this by some of my colleagues because we generally have a bit of a cut-off but she actually looks extremely well.Ìý I then said to her father, I think Rita was still under anaesthetic, that she may not cope and that she may have disabilities and that if she became more unwell we would talk about stopping intensive care.

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Bakewell

The tiny baby is a girl.Ìý Rita and Sanjay remember what it was like seeing her for the first time in intensive care.

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Sanjay

I could just about see through the incubator and she was absolutely tiny, she was as small as the palm of my hand.

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Rita

The joy that you felt that oh god she’s alive and she’s here, along with the shock of seeing her in such a state as well, then real sadness that your baby’s very early on in her life is just having to fight for her life as well.

Ìý

Bakewell

They name her Anya.Ìý Because she’s so tiny, Rita and Sanjay anticipate problems ahead.

Ìý

Neonatologist 1

After about a week Anya had a very significant respiratory deterioration, she became much sicker, her ventilation escalated up to a level at which there really was nothing else we could do.Ìý And this is not uncommon in babies such as her, where you have to turn to her parents and say – we are doing all we can, if she doesn’t respond to this we will not be able to save her.

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Sanjay

One time I actually had to send you out of the room because it just looked really, really bad and you know when a nurse is just standing there and they’re going – breathe baby, please breathe – you think this is it now.Ìý But then she picks up again.

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Rita

The next three or four weeks were just constant ups and downs.

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Bakewell

After about five weeks, Anya develops a problem with her gut that often affects these very premature babies.

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Neonatologist 1

We were extremely concerned about Anya, she developed abdominal distension, her x-rays didn’t look normal.Ìý And I think it’s fair to say that there was a high chance that she wasn’t going to survive.

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Bakewell

Once these tiny babies are out of the womb it’s up to intensive care to give them the best chance of life.Ìý Unfortunately there’s no treatment that can prevent restricted growth in the womb before they are born.Ìý Professor Anna David is an Obstetrician researching diseases of pregnancy at University College London.

Ìý

David

We are very good at following up women and deciding when to deliver them but we certainly don’t have any treatments that we can give women to help the baby grow more.Ìý Our prevention strategies are also very poor.Ìý So I feel very frustrated when I talk to women and their families about the fact we can do very little, apart from plan when to deliver and how to deliver and that’s it.

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Bakewell

Why is that?

Ìý

DavidÌý

Partly because we are worried about developing treatments for women who are pregnant because of the historical issues to do with thalidomide and other treatments that were given to women in the 1950s, ‘60s, ‘70s and so the regulations got much more complicated about doing drug trials in pregnancy and people also take quite a paternalistic attitude to women who are pregnant.Ìý Sometimes the healthcare workers are less willing to allow them to take part as they feel that asking whether they would take part in a trial is additional stress and that would be too much for them.Ìý But we really do need to develop some treatments because pregnancy is the future of mankind and so without some kind of treatments we’re really not helping women have healthy babies and healthy families.

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Bakewell

It has been difficult to get the pharmaceutical industry interested in funding drug trials in pregnant women.

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David

They don’t understand pregnancy diseases as diseases because when you look at registries of diseases there’s categories for cancers, categories for coronary artery disease but nothing for pregnancy itself.Ìý So even if you’re interested in funding this you may find it very difficult to find out what is your market, how much does it cost to delay or prevent preeclampsia, how much to delay or treat severe foetal growth restriction.Ìý It’s going to cost a lot of money if we fail to treat these pregnancies appropriately but the market value to try to help the pharmaceutical industry understand what they’re getting in to, very difficult to find out that information.

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Bakewell

Anna David is involved in two trials.Ìý The first, STRIDER, is recruiting women that have growth-restricted pregnancies to trial a drug called Sildenafil, also known as Viagra, to see if it improves blood flow to the placenta and increases the growth of the baby. The second trial, called EVERREST, starting next year, will investigate whether gene therapy does the same.Ìý

Ìý

But developing these therapies is a huge challenge.Ìý Unlike other diseases, baseline data on pregnant women with growth restricted pregnancies is lacking.

Ìý

David

Given that we’re in 2016 it does seem really crazy that we’re having to go back and do all this basic development that we need to develop drugs in pregnancy.Ìý But the basic data is simply not there because there has been very little investment in developing obstetric therapeutics.

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Bakewell

But trialling untested drugs on pregnant women is ethically challenging.Ìý

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David

It is very challenging because you’re talking about giving women treatment for a baby that may do more harm than good.Ìý So you may actually cause a baby to be born that would otherwise die in the womb but you may have a baby born that survives but survives with a very poor quality of life.Ìý Is that the right thing to have done for that woman and her family?

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Bakewell

We come back to our discussion again, taking up this question of the ethics of clinical trials.Ìý Now Deborah, why do you think pregnant women have been so under-represented in clinical trials, is it the shadow of thalidomide?

Ìý

Bowman

I think thalidomide for understandable reasons has cast a very long shadow.Ìý There are certainly some ethicists and obstetricians, actually, at Johns Hopkins – that’s in Baltimore – who have argued that actually had there been research involving thalidomide for morning sickness, which was of course a condition of pregnancy, one would have realised much sooner that there was a problem and therefore the trial would have been stopped.Ìý So in fact thalidomide is not a crisis of research, it’s a crisis – they argue – of not doing research.Ìý However, today the much more significant thing is that pregnant women are still seen as a vulnerable group who can’t make decisions about the risks and benefits of taking part in research and that’s a real problem.

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Bakewell

Neil, what do you think?

Ìý

Marlow

Not to trial drugs is in my mind unethical because you’re introducing developments and advances without the information to tell you that they’re safe.Ìý And so I think we have to do that.

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Bakewell

Susan, you’re nodding in agreement here.

Ìý

Bewley

I am nodding in agreement.Ìý I think pregnant women and their children are not well served by pussing footing and actually doing the wrong thing.Ìý For example, we gave babies too much oxygen for many years, causing blindness.Ìý We really need to know.

Ìý

Bakewell

Neil, what do you think?

Ìý

Marlow

I mean it’s very difficult because you are giving the drug for the purposes of a third party who happens to be part of the woman’s body at the time.Ìý And I think the medical profession have a duty to engage the drug development in pregnancy in the same was as we have a duty to do this in neonatology.Ìý We also need to use our own databases, we collect data on all sorts of things but we don’t talk to each other.Ìý And the health service is a fantastic resource.

Ìý

Bakewell

Good cases being made here for collecting data for doing studies but wait a minute – Deborah – is it ethical to expose a foetus to untested drugs?

Ìý

Bowman

In order to do research where there may be a benefit what you have to have is what’s called clinical equipoise, so you’re not sure whether practise as usual, how that compares to this other new potential thing.Ìý So it’s ethically justified because you have uncertainty.Ìý And pregnant women are making judgements every day about the sorts of risks that they do and don’t want to take.Ìý And I don’t perceive this as different.

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Bakewell

Now Neil you’re on the consortium for the EVERREST clinical trials, which have asked pregnant women about taking part in drug trials, now what do they say to you?

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Marlow

The women say to us that they’re very happy to take part in trials and it’s really important that we engage the public in potential patients who are going to take part in it so that we can get the answers that we desperately need.

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Bakewell

But what anxieties do they have?

Ìý

Marlow

Whether it’s going to do harm to the baby.Ìý Whether it’s going to do harm to them because they put themselves at risk when they go into trials.Ìý And they have to weigh those up very carefully.

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Bakewell

It is distressing that the pharmaceutical industry is not taking up this interest.Ìý What do you think about that Susan?

Ìý

Bewley

I’m not sure that we’re ever going to persuade pharmaceutical companies that there’s a big profit here but there’s certainly a big gain in terms of life and health for many years.Ìý So I think the issues of partnering the right people, the right laboratories, the right scientists to answer these questions is there, who’s going to fund it?Ìý It’s always difficult.

Ìý

Bakewell

Deborah.

Ìý

Bowman

I’ve been very struck actually by the engagement of charities with particularly these two trials and that to me seems to be a very positive partnership that is real meaningful engagement and I don’t think medics and scientists can do it alone, you have to bring society with you.

Ìý

Bakewell

Well thank you Neil Marlow, Susan Bewley and Deborah Bowman because we’re going to find out now what happened to Clare and Rita’s babies.Ìý

Ìý

Both spent several months, at times critically ill, in hospital.Ìý However they are now both home and, while each has had setbacks, they are getting stronger by the day.

Ìý

Samuel, Clare and Steve’s son, left hospital in January.Ìý He still lives with the effects of his premature birth - he has a hole in his heart, impaired hearing in one ear and receives oxygen through a tube in his nose to help with his breathing.Ìý At the time this programme was made in June, Samuel was still waiting for his heart operation and his family are hopeful that he will be able to breathe without support very soon.ÌýÌý

Ìý

Steve

Hello little chap.Ìý Since coming home he’s come on leaps and bounds.Ìý He struggles with his breathing but he’s starting to progress now and he’s a very happy baby now.

Ìý

Clare

And dribbling everywhere.

Ìý

Steve

More milk?

Ìý

Clare

He’s putting his hands in his mouth, he’s grabbing things, he’s trying to rollover, he’s chatting away.Ìý So I can’t see there being any problems with him but obviously in years to come there might be and if there is then obviously we’ll deal with that.

Ìý

Steve

Everything we’ve been told about the problems he could have I feel much more confident now, he might be slightly slower developing for school and things like that but I know he’s going to get there because he’s so happy and boisterous and I think he takes after mum and dad.Ìý I feel a lot happier now.

Ìý

Bakewell

Anya, Rita and Sanjay’s daughter, celebrated her second birthday in June and was making good progress since she came home in the winter of 2014 in time for Christmas.

Ìý

Rita

We didn’t think that we’d actually get there.Ìý It was just the best wasn’t it?

Ìý

Sanjay

Obviously, the family was around and…

Ìý

Rita

We did turkey and lots of presents for her obviously and that, yeah.

Ìý

Sanjay

You just look at her and you think – it could have really been…

Ìý

Rita

Been a completely different story.

Ìý

Sanjay

Yeah exactly.

Ìý

Rita

Daddy, kiss – go daddy, go daddy.

Ìý

Anya’s never been a massive baby so we accept the fact but at the moment they have no concerns in terms of her development but obviously we don’t know down the line but at the moment she’s a rowdy two year old.

Ìý

The only thing that’s been highlighted at the moment is her vision, so she might need glasses.

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Sanjay

One of the things that they told us about was the chronic lung disease, by the time maybe she’s four or five that would have improved but it’s all with time, you know.

Ìý

Rita

She’s got a brain of her own and she’s a real fighter and to be fair we wouldn’t have her any other way because had she not been a fighter then I don’t think she’d be here.

Ìý

Sanjay

She wouldn’t be here.

Ìý

ENDS

Ìý