Today a rather nice study of 15 million pregnancies provides some insight as to why the 39 week rule might be doing the harm that it is doing. This systematic review and meta—analysis showed clear increase in stillbirth risk from 38 weeks. Such that you have to think that if there is a line in the concrete at 39 weeks that this would inevitably mean increased risk of stillbirth.
I have recently returned from the USA where one of the topics of concern is the 39 week rule. While there is rhetoric from ACOG that this rule has done no harm in fact there is much evidence that the opposite is true. Today a rather nice study of 15 million pregnancies provides some insight as to why the 39 week rule might be doing the harm that it is doing. This systematic review and meta—analysis showed clear increase in stillbirth risk from 38 weeks. Such that you have to think that if there is a line in the concrete at 39 weeks that this would inevitably mean increased risk of stillbirth. While the numbers of babies potentially saved by “early term” delivery are admittedly small. This study does not support the rhetoric that 39 weeks is the new term and birth before this gestation will cause more harm than good.
I was recently very privileged to attend , and present at the Star Legacy Foundation stillbirth summit.
There I presented on Randomised controlled trials and their suitability for use to investigate stillbirth. Several people who weren't there have asked me to share my presentation with them. I've created a youtube video of my presentation It is very common for people to have a fatalistic view towards Stillbirth, as seen by these two examples of tweets in response to Senator Keneally's tweet about her party's commitment to reducing stillbirth should they win Government at the next election While it is true that a certain proportion of all stillbirths are "more about mother nature" and try as we may we can never hope to prevent stillbirth altogether...at least not until we have figured out how to correct fatal fetal abnormalities before a stillbirth occurs BUT...there is no doubt we can lower the rate of stillbirth in this country.
How can I be so confident? It has to do with knowing that when a Government sets its mind to reducing stillbirth that that is exactly what happens. How do I know this? Because it has worked in other high income countries like Scotland where there was a 20% reduction in stillbirth in Scotland when the Scottish Government funded a program to reduce stillbirth. How does funding help reduce stillbirth? Through education and awareness. Imagine for a minute if no-one knew the signs of an impending heart attack, and everyone just thought that deaths from heart attack were more to do with mother nature and there was nothing anyone could do to stop them...deaths from heart attack would go up ...right? Imagine also if we thought that SIDS deaths were inevitable...as we did in the 80s,.. and no-one knew to put their young baby to sleep on their backs, SIDS would go up again too...right? In much the same way some stillbirths can be prevented. Quite often a pregnant mum gets a warning that her baby is in trouble. In the 25 years since my baby Emma was stillborn I can't tell you how many times I've heard stories from parents of a stillborn baby that have made me incredibly cross because the mother noticed changes in her baby's activity or in her body , reported these changes to her care provider and was either falsely reassured or worse given incorrect advice. We can...and indeed we must....stop these deaths from happening. The Government spending money on public education and community awareness , alongside maternity care provider education will be effective in stopping these kinds of deaths. It is wonderful that we now have bipartisan commitment to do just that This may seem like semantics but I’m concerned about this messaging to pregnant women:
“settle to sleep on your side to improve blood flow to the placenta and the baby” I’m concerned because we actually don’t know why settling to sleep on your side reduces risk of stillbirth BUT we have no evidence whatsoever that side sleep improves blood flow to the baby. The evidence we do have is that settling to sleep on your side reduces your risk of stillbirth, and that when SOME women lie on their back SOME babies response seems to indicate that blood flow might be reduced in SOME cases. Further, talking about “improvement” suggests that side sleep inherently makes blood flow better. Making one ask the inevitable question “better than what?” The answer I guess is “better than being on your back” but actually that’s a bit of a logic leap because while we know that settling to sleep on your back probably reduces blood flow, settling to sleep on your side doesn’t actually improve flow… it just doesn’t reduce flow. Let me draw an analogy with the infant safe sleep campaign to make my point. We don’t know why settling a baby to sleep on their back reduces the risk of SIDS we only know that it does. When this was first discovered LOTS of theories abounded as to why it might be the case but ALL the public awareness campaigns simply said “Put your baby on their back to sleep to reduce the risk of SIDS” imagine if instead of giving the real reason some organisation was scared of using SIDS in their messaging and so instead said something like “put your baby on their back to sleep to improve air flow to the baby’s nostrils.” That messaging would be less effective for two good reasons: 1. People would have to know that reducing air flow to your baby's nostrils MIGHT lead them to being at risk of SIDS AND 2. more importantly in order to provoke behavioral change it's best to always give the real reason , not the sugar coated possible reason, So can we stop beating about the bush and just call a spade a spade and all just go with the same, simple, factual and correct message “Settle to sleep on your side from 28 weeks to reduce your risk of stillbirth” Last night the Select committee on Stillbirth research and education tabled its report in the Australian senate. It’s 187 pages and includes 16 recommendations that, if they are all implemented, WILL undoubtedly save Australian babies lives.
Anyone who knows me well will know I am an emotional at the best of times so as I was watching these senators deliver their accompanying speeches about this very important report …well it would be fair to say that there wasn’t a dry eye in my house :) The report addresses the senate terms of reference but also makes new recommendations addressing concerns raised by witnesses at the inquiry. To quote Senator Keneally from her speech: Broadly speaking, this report makes recommendations in three key areas. First, prevention: there are several recommendations that go to how we can help families and clinicians reduce the risk of stillbirth and know when we should intervene to save babies' lives. This includes national education, community campaigns, continuity-of-care models, and education and training for clinicians. Second, investigation: this includes investigating and understanding why stillbirth occurs, in order to better advise families in subsequent pregnancies and to recommend changes to clinical practice. These recommendations include investigating stillbirth properly, which we do not do, and that includes pathology and with autopsies. As a nation, we need to record information about stillbirths consistently and fully in the national dataset and make sure that data is made available to individual families, as well as in aggregate form to healthcare providers and researchers, as quickly as we can. Our recommendations also speak to the need for longer term funding certainty for research. Third, supporting families and clinicians after a stillbirth occurs: this includes care after a stillbirth to support families emotionally and, importantly, to ensure parents have access to paid parental leave and to help co-workers to support these parents when they return to work. Importantly, this report calls for a national stillbirth action plan that starts us on this effort by aiming to reduce the rate of stillbirth over the next three years by 20 per cent. This would be a remarkable achievement after 20 years of stagnation and inertia that has meant that so many lives have been lost and many more irreversibly changed. [my emphasis] There is much to be excited about in this report Firstly “the committee recommends the Australian government”….is wording that starts most of the recommendations, this is wonderful because it takes the onus off those organisations that are currently struggling with running on a shoe string budget and most importantly means that the resulting action, implementations, advice, consultation, will be truly collaborative and supported by ALL stakeholders keenly interested in reducing the tragedy of stillbirth. It is also exciting that the recommendations call for a “roundtable” of relevant stakeholders. Again this means that the committee realised that any one existing body would be better as a stakeholder presence at the round table rather than trying to led it. This also frees any one organisation from the responsibility of trying to pull this kind of thing together AND it also means all voices at the table will be likely to be heard The government responded swiftly to the tabling of this report by putting out a media release (see below) announcing…amongst other things… a national roundtable to address the rate of stillbirth in Australia and a commitment of an “initial” amount of 7.2 million. This is amazing because when government support initiatives in other countries they have seen reduction in stillbirth and one can only assume this is likely to also be the case in this country . Would you rather have a dead baby at 39 weeks or living baby at 38 weeks? Would you rather have a dead baby in your arms straight after birth or wait a couple of hours for a living baby (who had to go to the nursery) who you can then hold in your arms for the rest of their life ? Stupid questions… Right? I’m concerned because there is a growing narrative in Australia that we should “redefine” term along the lines of our USA colleagues and not induce birth until 39 weeks yet there are more and more reports suggesting that the 39 week rule is doing is own special kind of harm in the US, here is the latest from a study published in Hospital Pediatrics Title: NICU Admissions After a Policy to Eliminate Elective Early Term Deliveries Before 39 Weeks’ Gestation It was quite a large retrospective cohort study , here is a screen shot of the results I’ve highlighted a key sentence and ask “since when is an increase in stillbirths at term from .75 per thousand to 1.0 per thousand considered non-significant?” Yes I get that this was not STATISTICALLY significant. But this is a huge number of babies and so it’s a number that is MASSIVELY clinically significant especially considering that while making a claim for non-significance the authors should have admitted that the main reason why it wasn’t ‘significant’ is that their study was not powered for stillbirth. This is especially concerning because the authors then conclude Of course I am all for minimizing mother-infant separation but certainly NOT at the expense of baby’s lives! The 39 week rule in the US has been associated time and time and time again with an increase in stillbirths and yet the narrative still seems to be that it’s a good idea because of reduced short stay nursery admissions.
So once again I ask, do you think the .8% more mothers who were temporarily separated from their babies prior to the 39 week rule were harmed as much as the 33.33% more mothers who had a stillborn baby after it? Hmmm…stupid question.. right? Recently I was in a room full of ‘intelligent’ people. Many clinicians, researchers, bereaved parents, or all of the above, ALL passionate about reducing preventable Stillbirth in Australia. It was curious to me therefore, how very little I heard anything about the woman during the day. Perhaps it’s because I am a midwife and the midwifery philosophy of care is woman-centered but it was concerning to me how much of what was said and agreed to, completely lacked consideration of what the pregnant woman might be able to contribute to protecting her baby from the calamity of stillbirth, and instead how much paternalism was in the room. One particular comment that stood out as a shining example was this one, in relation to the group considering evidence that any change in fetal behaviour was important for the woman to report, rather than simply a decrease: I think we need to be careful about not worrying too many women and getting the whole cascade of intervention… “decrease versus change”, sounds simple but its going to alter the number of women who come in, we need to stick to safe evidence and make sure we evaluate a potential increase in adversity for the potential benefits we might get. We need to carefully balance benefit with potential risk, solid evidence rather than stuff that’s “possibly true.” I was tempted to respond BUT this comment was almost immediately followed by someone saying that perhaps they should change their flight and I thought, “if I get started on what was a load of !@## .well… we would all have needed to change our flights!” So let me jump on my soap box here and say what I should have said …if we had all had many more hours there. Firstly to ‘safe’ evidence. The evidence that we have that ANY change in fetal behaviour is a potential cause of concern is from case-control studies, one of our highest forms of strong evidence. In fact, the VERY SAME case-control studies that provide us with evidence that settling to sleep on your back increases the risk of stillbirth. So IF we are going to say we need to stick to “safe” evidence, then we need to also steer clear of giving the side-to-sleep message until we get ‘safe’ evidence that isn’t reliant on ‘recall bias’. We really can’t be so inconsistent as to accept some of the findings from these studies and “worry” women about sleeping position and be afraid to “worry” women with evidence FROM THOSE SAME STUDIES that shows ANY change in strength, frequency or pattern is something the woman should report. There also seemed to be a misconception in the room that ‘change’ was only to do with a change in frequency (decrease or sudden increase) however the evidence from ALL the aforesaid studies VERY consistently points to change in strength and pattern (especially not moving at bed time) as also being concerning symptoms, that need to be properly assessed. So the “change” evidence we have is to do with strength, frequency and pattern. So saying this again and louder, Decrease in frequency of fetal movement is undoubtably one of the most common SYMPTOMS that something may be amiss with the unborn baby. We now know from case-control studies that a decrease in strength, or a change in pattern, or a sudden burst of activity (described by the mother as “crazy”), are also ALL potential symptoms that the unborn baby MAY not be well. For a 20 minute youtube summary about this evidence go to this youtube video https://youtu.be/vVW8E4psnDk I often use heart attack as an analogy by way of making a point about how we currently treat the symptom of altered fetal activity so very differently from the symptom of chest pain, when perhaps we shouldn't. The prevailing symptom of heart attack is chest pain BUT we all know it is not the only symptom. Imagine for a minute that we regressed to the dark ages where doctors thought giving people life saving information about ALL symptoms to be aware of and report was not a good thing … (wait :) …anyway), image that we thought that we would have too many presentations to emergency room if we gave the general public all the symptoms of heart attack and so to keep things simple for ourselves and catch MOST of the heart attack victims we only said present to emergency if you have chest pain. Would we not miss those people who presented with atypical symptoms such as pain or discomfort in one or both arms, the back, neck, jaw or stomach, or shortness of breath without chest discomfort, or other less typical , but still concerning signs, such as breaking out in a cold sweat, nausea or lightheadedness. YES …WE …WOULD. So WHY do we feel we shouldn’t give ALL women, every bit of strong repetitively validated evidence we have to help them keep themselves and their baby safe? …………………..it comes down to that word “worry”. I put “worry” in quotes because we have ABSOLUTELY NO evidence that giving women information about how to keep herself and her baby safe during pregnancy is worrying. In fact, withholding vital health care information because we think it might be worrying is the stuff of dark ages that we have moved on from in EVERY other field of health care provision, apart from obstetrics. Even so we do routinely give pregnant women all sorts of other ‘worrying’ information without worrying that we are worrying her :). We tell her to avoid soft cheese, and alcohol yet the risks of her actually losing her baby to Listeriosis or FASD are astronomically low, FAR FAR lower than the number of babies who die following an episode of altered fetal activity. Some smart people in that room were worried that giving more information, might increase unscheduled presentations to antenatal care and therefore the potential for harm such as induction of labour, but here’s the thing, IF more women present to be assessed because we have given them more information then OF COURSE that presentation MAY result in detecting the baby who is showing signs of being unwell, and that baby being induced and the thing about that is that if we induce and the baby is born alive and well then some clinicians seem to think that is an adverse outcome. This kind of thinking is totally illogical and akin to those who seem to staunchly believe in the concept of the “unnecessarean”, people who think that if a baby was born alive and well following an emergency caesarean that the caesarean was unnecessary!! So let’s all get a grip and trust care providers that they are not going to intervene to end a pregnancy unless they see a good reason and also trust women that they are not vulnerable people to be protected, but mothers who can be trusted , have agency and thus need to be given ALL the evidence we have at hand to enable them to advocate for their unborn baby and help protect them from harm. There are a LOT of myths out there about fetal movements. Often it is thought that pregnant women are the only people that can hold to these myths and that maternity care providers know better but this is actually not always the case. What is the definition of a myth? a widely held but false belief or idea Maternity care providers (and sometimes even researchers) often belief the myth that a well fetus will move an average of 10 times in 2 hours. This is dangerous because many care providers will tell a woman who is concerned about her baby’s movements to count to 10 over the next 2 hours and if the baby moves as little as that then all is well. This advice is given because it is THOUGHT to be based on evidence. I hasten to say that believing this myth is not necessarily the care providers fault because this myth has even made its way into many clinical practice guidelines and once there has become part of circular citing. Circular citing is a pretty common occurrence where a paper has been incorrectly cited once (often by a person or body that appear authoritative) and then others also incorrectly cite it too. This results in a Chinese whisper of sorts that is often really hard to unpick Most clinical practice guidelines that bother to give a reference for the “evidence” that a well baby will move 10 times in 2 hours refer to an abstract reported by Moore and Piacquadio 1989. Seen in its entirety below As you can see these authors asked women to record the “elapsed time required to appreciate 10 fetal movements”. The mean time was 20.9 mins, with one Standard deviation being 18.1 minutes. This means that the vast majority of their participants felt their baby move 10 times within a time frame of between 2.8 and 39 minutes. FURTHERMORE, they asked women for whom 2 hours had elapsed WITHOUT 10 movements to report to delivery suite BECAUSE this alarm limit was 5… YES FIVE standard deviations away from the mean (or average) i.e. really really really really really rare !!!!!!!!!!!!!!!!!!!!!!!!
This means that FAR from representing what an average baby does, moving only 10 times in 2 hours is INCREDIBLY rare and therefore VERY likely to represent a baby it HUGE increased risk of stillbirth. This report of a study, that many clinical guidelines have subsequently cited as evidence of what’s “normal,” has been misquoted, mis-cited, and misinterpreted. If anything this study shows that a normal baby moves ON AVERAGE 10 times in 21 minutes and that IF it takes the mother more than 39 minutes to count to 10 movements then this is well and truly outside most babies ‘normal’ range. The authors of this commonly cited paper conclude that a “count-to-ten” movement screening program is simple and effective in reducing the fetal mortality rate. NOTE : WHAT THEY DO NOT SAY WHICH IS REALLY REALLY IMPORTANT TO APPRECIATE IS… Moving 10 times in 2 hours is what the average baby does. WHAT THIS STUDY ACTUALLY SHOWS IS IF THE WOMAN DISCOVERS HER NORMAL by counting how long it takes for HER BABY to move 10 times THEN this is an effective way to reduce stillbirth ESPECIALLY IF she is told to report if her baby is moving WAY WAY WAY WAY WAY below the normal level of only 10 movements in 2 hours. So in sum, if you want to based guidance on this report then please use it correctly and tell women that an average baby moves 10 times in 21 minutes and that even if you have a quiet baby they will probably move at least 10 times in 39 minutes and if your baby is moving as little as 10 times in 2 hours then this is WAY outside the normal range and the mother needs to be immediately assessed NOT reassured. Better still stop using numbers , hours and counting altogether and simply tell the mum to get to know who her baby is so she can know how her baby is so she can immediately report change and LISTEN to her when she reports concerns! OK its time for me to call Bul***it !!
A well conducted RCT has not shown the expected 30% drop in stillbirth and many commentators are suddenly ,and very dangerously ,saying that maternal awareness of fetal movements is not an important preventative factor for stillbirth. This is nothing short of an astounding conclusion. It flies in the face of EVERYTHING we know from multiple well conducted observational and experimental studies done over many years. It doesn’t make sense and most importantly those who are using words like “harm” and “flop” in connection with this study and its findings should be ashamed of themselves as they are directly placing babies lives in danger. As I already said the study actually does show a reduction in stillbirth, 9% …that’s NINE percent. About 77 women are holding their babies in their arms as a result of their hospital participating in this study instead of visiting their graves. So why is this study being called a flop, and a failure? Well its because the investigators powered their study for at least a 25% drop. That means that when they calculated how many participants they needed to show a statistically significant difference in the stillbirth rate they looked at the aforesaid studies and made their calculations based on them, no doubt thinking that a RCT design would be able to show a similar effect size. With the benefit of hindsight I hope they are now thinking it would have been far better to have taken a more modest approach. Why? Because, of course, in the meantime the cat is well and truly out of the bag. What I mean is that the information that they gave the women in the study was already in general use as was the pathway for the care-providers response. In spite of this FACT the intervention STILL worked to reduce stillbirth by 9%! Why? Because mums were made aware of the importance of fetal movements and their care-provider acted appropriately when they reported those concerns. I often compare protecting the vulnerable baby from stillbirth to how we have protected the vulnerable baby from SIDS and this is an appropriate analogy to make again here I’d like the naysayers of this study to imagine that someone has recently completed and reported a very large well conducted RCT published in one of the best medical journals in the world. The study was an intervention in which parents were told to place their baby to sleep on their back to prevent SIDS. The study was powered on an 80% drop in the SIDS rate (as this is the drop that has been reported following the back to sleep campaigns). The study reports that they could not replicate this drop in their RCT and that therefore placing the baby in the supine position to prevent SIDS “remains unproven”. Would there, or would their not be an outcry from the SIDS community? Wouldn’t they say there is no way such an RCT would be able to show that kind of reduction now because the information about putting your baby back to sleep is already well known? YOU BET THEY WOULD and so actually the stillbirth research community AND those whose baby’s lives have been saved as a direct result of being made aware of the importance of fetal movements need to voice their concerns in the “controversy” that CI Norman seems to be expecting and do the same When it comes to investigating the effect of an intervention that is already well known RCTs can't possibly "prove" a concept thats already in no doubt, yet in spite of this the study showed a 9% reduction! If anything this shows that awareness IS important. So now I am prepared to go on record and predict that when the other large randomised step wedge cluster RCT ‘my baby’s movements’ study in Australia is published it will also not show the expected drop in stillbirth and some might also call it a “flop” and a “failure”. Hopefully most of us will be smart enough to shrug and say “of course not” and move on with continuing to save baby’s lives by telling the mum about the importance of fetal movements and acting appropriately when she presents with concerns. Yesterday the long awaited results of the AFFIRM trial were finally published in The Lancet. It is a little unfortunate that the authors didn’t make more of the drop in stillbirth rate that they did show, and its incredibly unfortunate that the accompanying commentary was titled
Encouraging awareness of fetal movements is harmful…...really??? Now that’s what I call calling a spade and spade! However, I’m not sure that the reported 9% reduction in stillbirth could EVER be seen as harmful especially as the ‘harm’ is a reported increase in CS rates of 6.3% and term IOL by 3.5%. The problem with the AFFIRM trial and the ARRIVE trial and others like them is that because the intervention was not objective ...black and white (take this drug or this placebo) it could very easily have been adopted differently by different hospitals and care-providers within the hospitals, AND because women can get their information about fetal movements from many other sources other than the trial’s protocol AND that care-providers can, and do, act in ways that are not in keeping with the trial protocol AND S**T happens it is difficult (and I am actually coming to believe, impossible) to control for all those variables such that a RCT that has ended up demonstrating a 9% reduction in stillbirth has my tick of approval for the effectiveness and value of making women aware of the importance of fetal movements! It is a real shame that the authors powered their study on a 30% reduction which (with the benefit of hindsight) they must now be regretting because a 9% reduction in stillbirth is definitely NOT harmful, a 9% reduction in stillbirth is amazing, a 9% reduction is spectacular number of babies saved. The AFFIRM trial shows that when mothers are made aware of their babies movements and the maternity care provider acts in a standardised fashion that you can reduce your stillbirth rate by 9%.......would someone please tell me how that is anything other than really really good? |
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