Episode 209 - The 5 BIG Induction Studies
Mel:
[0:00] Welcome to the Great Birth Rebellion podcast. I'm your host, Dr. Melanie Jackson. I'm a clinical and research midwife with my PhD. And each episode, I cast a critical eye over current maternity care practice by grappling with research and historical knowledge to help you get the best out of your pregnancy, birth, and postpartum journey.
Mel:
[0:26] Welcome to today's episode of the Great Birth Rebellion podcast. Today, I'm joined by Professor Hannah Dahlen, who is a professor in midwifery at Western Sydney University. She was also my PhD supervisor. We have worked on many research projects together, written research articles together. She remains my long-term friend and midwifery mentor, and she is a force in the midwifery world. Hannah has done research on induction throughout her career and is across all the research. She is the best person I can think of to have this conversation with today. So if you haven't heard Hannah talk on the topic of induction yet, you are in for a treat. She's a pleasure to listen to and makes a whole lot of sense.
Mel:
[1:11] Today we're talking about the big five induction trials that are being used as evidence to support the use of induction of labor for big babies, for older women and for women who are having longer pregnancies. And often you'll be offered an induction if your care provider believes that your baby's over four kilos, if you are over 35 yourself, or if you're pregnant beyond 41 weeks. That's some of the reasons you'll be offered an induction. Today we're going to pick apart the five big research papers and the big research studies that many care providers will use to support the use of induction for these reasons. These five big studies are the ones that your clinician will quote to you, if they are encouraging you towards induction or maybe even if they've read them thoroughly they're just keen to let you know the information that's out there to help inform your decision if you're deciding between induction or to do something else.
Mel:
[2:11] The five big studies that we're going to talk about today are the 35/39 trial, the INDEX study, the ARRIVE trial, the SWEPIS study, and the Big Baby trial. This is going to be such a juicy episode. This episode is sponsored by my dear friend and birth prep extraordinaire, Poppy Child from Pop That Mama. She's a doula and hypnobirthing practitioner, and her online hypnobirthing course called The Birth Box has already helped thousands of women get ready for labor. Listen to this recent review of The Birth Box. The woman says, I'm a first-time mom and I gave birth to my beautiful baby boy yesterday. I've been listening to The Birth Box on repeat for the past few months, including the day in which I went into labor, and I had the most empowering birth experience, and I can honestly say that listening to The Birth Box was a huge part of this success. Reframing the pain that you experience during labor can be a purposeful pain instead of a harmful pain and that really helped me to know that, and just being able to surrender to the wild ride that birth is and let my body take over was the most incredible thing.
Mel:
[3:26] And this is coming from a pelvic floor physiotherapist based here in Australia. She says, I will recommend it to all my patients. And you know me, I'm so picky about what I will endorse, but I do get behind the work that Poppy is doing. And in the birth box, you'll learn tools to help you manage pain and how to stay steady when labor gets intense. It's all about giving you knowledge, confidence, and a mindset that actually works when the big day comes and for the big days that will follow. BirthBox is rated five stars across the board. And with my code, Melanie, you'll get 25% off. So if you're preparing for birth, go to the checkout. You'll be so glad you did. The link is in the show notes. Use the code Melanie to get your 25% off. These are all the nicknames for these studies. And of course, I will give you their full titles and all the actual research papers in full text so you can follow along for yourself. They're all in the resource folder for you to read, so don't just take our word for it.
Mel:
[4:32] All you have to do is get on the podcast mailing list at melanethemidwife.com and you'll get immediate access to the resource folder, which is full of a back catalogue of resources for every single Great Birth Rebellion episode. And for the midwives and doctors who are here listening, helping women make fully informed decisions around their birth options, this is a great episode to refer them to because they can look at the studies themselves and be involved in the conversation so that they can make a choice that makes the most sense for their personal circumstances. I get it that so many maternity care providers out there are short on time and feel like they can't give women all the information they want to give them to help them make fully informed decisions. So if a client of yours or you're sitting with a woman who's considering their options about induction or non-induction, this is a great resource that they can go away, have a listen to, and you can come back and have a conversation with her knowing that she's received, some information that she can use to make an informed decision. Welcome to the Great Birth Rebellion podcast, Hannah.
Hannah:
[5:42] Thanks, Mel. My pleasure to be here again.
Mel:
[5:44] Many people who are listening would already know who you are, but there are a collection of early listeners or first-time listeners who are joining us for this episode. So for their benefit, can you tell us who you are, what you do for work, and why you're the person that should be talking about these particular studies?
Hannah:
[6:04] I'm a professor of midwifery at Western Sydney University in the School of Nursing and Midwifery. I'm also the Associate Dean of Research and High Degree Research. I've been a midwife for 35 years. I've worked in private practice for about eight of those years and a lot of that time with you, Mel. And I've done a few studies on induction more of late. The way I kind of describe it is that I feel like I'm playing whack-a-mole. For the first part of my career, it was all about caesareans and how do we prevent them and how do we show the morbidity. And meanwhile, induction of labour has kind of snuck up on the inside passage. So I've now gone, right, I'm after you. And I've become very interested in the discourse around that and what's actually going on.
Mel:
[6:47] Yeah. And that was one of the reasons I really wanted to talk to you about induction, because I know that you've done some research projects about induction. And in order to do that, you need to be across all the induction literature. And you've got a real knack for understanding it, but also explaining it in a way that we could all understand. So we're going to look at the big five today, and I realize that is a lot of information to condense into one single podcast episode. So we're going to do our best to be succinct with it all. You've got five big studies, the 35/39 trial, the INDEX trial, SWEPIS study, the ARRIVE trial, and the Big Baby study. And for everybody who's listening, we will make sure all those papers are in
Mel:
[7:32] the resource folder. You can read them for yourself and just cross-check our analysis of all this. So let's start with the kind of the thing that kicked it all off, that 35-39 trial.
Hannah:
[7:46] Should we start even before that though, Mel, with what is the rate of induction in Australia? Because I think a lot of people don't realize that it is as high as it is. So overall, it's now 33%. That's of the latest data we have in 2022. But if your first-time mother having a baby, your chance of being induced is now 43%.
Hannah:
[8:08] And just to give you a little context, that's increased from 26% in 2004 to 43% in 2022. That's a massive, massive increase in what is a major medical intervention. And now, if this was saving lots of babies' lives, I think women and clinicians, as one would say, well, it's probably worth it. Women need to make that final decision. But, you know, if we are saving lots and lots of babies, brilliant. And the reality is, though, that the perinatal mortality rate has barely changed over the last decade, even longer than a decade. So we're doing more and more and more to women. We're not getting any huge differences in outcomes for babies, which is the primary reason why we induce, let's face it. It's usually about the baby. And yes, women are more complex in their health picture. But if you look at every single category of every age and risk or no risk, every single aspect, we're just going upwards. So the argument that this is all because of the increased risk of women is a very lazy argument and I think it needs to have a good hard look at it and we need to challenge it.
Mel:
[9:25] And although the induction rate is increasing and we're not really changing, mortality stats for babies, the rate of babies who are needing special care unit and NICU is increasing.
Hannah:
[9:39] It's high. What is going on that we've got these incredible, what we call clinical variations going on?
Mel:
[9:46] Yeah, I think we definitely need to look deeper into less focus. I mean, yes, focus on improving. How many babies die, of course. But we're not looking at all of the other outcomes. It's very narrow focused. So 43% of first-time mums, 33% of women being induced in Australia. And I'm sure that is being mimicked over the world. Is this an unusual pattern?
Hannah:
[10:13] No, in all of the high-income countries, we're seeing that pattern happen. And we're also seeing obviously the rise in cesarean section, that continues to be an aspect. And if you look at the United Kingdom now, they have very similar, if not higher rates of induction. And in fact, their cesarean section rate has now gone past 40%. Now, never would we ever have thought that. They were always the one leading the way on what we wanted to be like, not what we now don't want to be like.
Mel:
[10:42] Why do you think it is? Why are the induction rates increasing like this and cesarean section rates.
Hannah:
[10:48] That is such a complex answer and i think you'd need 10 podcasts to answer it but if i were to capture one kind of heart i would say it's about fear and it's about our obsession with risk but not a balanced obsession it's about protecting ourselves it's about also never wanting to be involved in a situation where a mom loses a baby and that is a pretty awful place for the mom where it's a terrible place for the mom but a pretty awful place for the provider it's about litigation it's also about who holds power in our maternity care services who is the one that or the or the discipline that calls the shots and then that's about the lens through which they view women and do you view them as until our baby's out and that baby's got app guards of nine and nine and it's fine i am going to always think something can go wrong or do you view it that But until I see evidence of something going wrong, I'm going to have trust, faith and close trust. You know, watchful attendance as we've written about, and I'm going to respond when that needs to happen. And of course, that's the midwifery perspective. So often in obstetrics, because they're trained to deal with problems. There is the very risk-focused perspective.
Mel:
[12:09] So, I mean, generally then sounds like it's a symptom of the medicalisation of childbirth. We're approaching it like a medical pathological event and this is the snowballing of that philosophy is showing up in increasing induction rates.
Hannah:
[12:27] Yeah, and also then build into that a patriarchal framework, which is around the, you know, not having that faith and understanding and respect of women's bodies and their power and their role as mothers, then throw on top of that industrialization of our health systems where we pump people in and we pump people out. It's not surprising that we're where we are. Not surprising at all.
Mel:
[12:52] Yeah, I agree. And into that then, that kind of desire and intentionality and the philosophy to be medical and approach birth in a medicalized way, So in come these studies, that seem to endorse that way of managing birth.
Hannah:
[13:08] Yes, and so we've had back into the 60s we've been doing studies on induction of labour, generally looking at inducing women between 41 and 42 weeks or, you know, at 42 weeks not letting them go over or at 41 weeks. So we've had these studies going on for a while and they formed the Cochrane database. base. But what's happened in the last decade really is that we've had this very strong focus on big randomized control trials on specific questions. And those questions are around older women. Those questions are around post dates or 41 weeks and on. Those questions are about, can we reduce the stillbirth or the perinatal morbidity if we induce women at 39 weeks when And hopefully the baby's respiratory system is developed enough, but we kind of curtail the risk of stillbirth. And then we've also got that question, which has just come out in the last couple of weeks, which is... What if we induced everybody, all the women who have a baby that is predicted by ultrasound to be greater than 95th centile, if we induce them, can we reduce shoulder dystocia? So each of them asks slightly different questions, but they've all got very similar kind of methods in how they go about it.
Mel:
[14:26] Yeah, and this is the thing. It's the randomized control trial, and I'm sure we're going to talk about, you know, historically randomized control trials were considered the most superior way. Of researching something because the methodology is quite rigorous, but we're dealing with women and people here who aren't sick. It's not like we're comparing one product to another product or one product to a placebo or something that's, you know, so many controllable factors when you're doing something like that. And applying a randomized control trial to a specific birth choice has got so many confounding factors and, possibilities for things to be.
Hannah:
[15:05] Yeah, and it is the gold standard. There's no doubt that when it comes to testing an intervention on what you define as your primary outcome, a randomized control trial is the best way to do it. It's the best way to do it for medication. It's the best way to do it for medical interventions, but it will answer the question you give it. It's not like some sort of genius that goes, well, thank you very much, Hannah, for your question, but I'm also going to give you all these other contexts. It doesn't do that. And so, you know, we need to ask the questions such as how many people were approached to get the sample you've got.
Hannah:
[15:38] Now, you know, when we talk about the induction of labor trials, you're going to see that up to 86% of women approach to say, no, thank you very much. And most of them don't want to be induced. So then we talk about things like generalizability. How applicable is that to the population as a whole when such a huge number of people don't think that that's an acceptable line for them to go down. So, randomized controlled trials are the gold standard, but we should still ask a lot of questions. And the other big thing is we should never inflate them beyond the primary outcome they were set up and powered to tell us about. And people consistently do that because we're human and people have political agendas. People get millions of dollars to do massive trials and they are hoping to goodness that their trial shows them what they set out to show because if it does, they'll get cited more, they will have more impact, they'll get promoted more, their article will be read more, it will hit the media more. And so there's an element of being human as a researcher that means that all of us out there have to keep our researchers accountable to what their brief is and their need to be very... Humble and they need to be very cautious, which should be the core tenets of being a good research.
Mel:
[17:00] I think we should get into it. So, let's kick off with the first one. Which one makes sense to go through first?
Hannah:
[17:08] Shall we start with 35? I mean, essentially, if we look at the order, that came out in 2016. So, it's one of the earlier of these sort of five trials. 35, 39 trial. So basically, it's as the name says, that they were looking at women who were greater than 35 years of age, getting induced at 39 plus zero to 39 plus six or weighting. So it was to see whether or not older women, older women will lose fewer babies essentially and have less perinatal morbidity for their babies if we induce them at 39, between 39 and 40 weeks pretty much.
Mel:
[17:52] Over 35, not over 40.
Hannah:
[17:54] Over 35. So women over 35. They ended up with 619 women in that. But let me just again point out that 4,000, 4,500 were eligible and only 14% agreed. And out of that lot, a large number didn't want to agree because they wanted to wait. It was only primips, which kind of controls that variability you've got with primips and multis. We know that the rates of morbidity are higher having your first baby. There was a mean gestational age difference of one week. So even though women were randomized to the induction arm, actually women who were randomized to the waiting arm, nobody really waited longer than a week, more than in the other arm.
Hannah:
[18:41] The caesarean section rate was identical between the two groups. It was non-significantly, it was totally the same, which was 32 in the induction group and 33 in the waiting group. The instrumental birth rate was a little bit higher in the induction rate compared to the expectant, but again, that was quite small. It was 38 compared to 33. And this is the key thing. There was absolutely no significant difference in any of the other outcomes. So, when they're looking at all of the baby morbidity outcomes, there was no difference. And so, the conclusion should be that inducing women routinely over the ages of 35, 39 weeks does not show benefit for the baby and there doesn't seem to be any benefit for the mother. That's the conclusion. You ask midwives out there on the ground and they'll tell you literally every woman is now being recommended to have their baby. 39 weeks, which is probably because people are conflating the ARRIVE trial now with So they're giving instructions around older age and they're in the back of their mind. They don't realize they're mixing up different types of outcome results.
Mel:
[19:56] And so you said the conclusion should be that it makes no difference if you're over 35 to be induced or not in terms of stillbirth rates and outcomes for babies. What did the study say?
Hannah:
[20:07] They were pretty cautious. I've got to say it was a UK study. So they were pretty cautious in that study. You don't have the concerns that you have in some of the other ones that I am going to start to tell you about. Do you want to talk about ARRIVE? We really arrive at where bias is set down in reporting research.
Mel:
[20:29] Well, we'll definitely have a look at the ARRIVE trial. So for that trial, basically then, has there been any other research that clinicians have been using then to recommend induction for over 35-year-olds? Is this?
Hannah:
[20:43] Yes, because if you actually look, and this is a really important thing, if you actually wanted to eliminate as many stillbirths as possible without really impacting on baby outcomes, the lowest stillbirth rate sits at about 37 weeks, right? So it's about 1 in 10,000. And then literally for every week after that, it doubles. But we're still talking from 1 in 10,000. 2 in 10,000, from 2 in 10,000 to 4 in 10,000, from 4 in 10,000 to about 8 in 10,000, and on and on it goes until we end up at 42 weeks with around 32 in 10,000 or say 3.2 in 1,000 as a risk. So there's no doubt linearly that every week you're pregnant, the rate of stillbirth goes up, but proportionally it's still tiny increases. So, there's that. Then we do know from our big cohort studies that women who are older have higher rates of stillbirth. If you look at all of that data and that's everybody put in there to get you a risk of stillbirth, if you then just look at low-risk women, you can literally take their statistics back a week. So, a low-risk woman compared to a woman with risk factors is going to be a week behind in her stillbirth risk compared to somebody who's got risk factors.
Hannah:
[22:05] So a woman who is 35 and over, yes, the rate of stillbirth is higher. Not astronomically, but it does rise with maternal age. And so if you conflate that stillbirth goes up every week and you then take older women where stillbirth is higher, you can see you can put those two together and say, well, let's induce them earlier to have an impact on this.
Mel:
[22:26] Well, and the way of explaining it, so you could explain to somebody that every week you're pregnant, the stillbirth rate doubles. That's very frightening information. But if you, as you explained it, said, one in 10,000 at 37 weeks and then two in 10,000 and then four in 10,000 and then eight in 10,000 and then, yes, we acknowledge it at 42 weeks, the risk compared to 37 weeks is significantly more. But still, if you say to a woman at 42 weeks, your risk is 32 in 10,000. That's information that the woman can use to make a decision about her risk level. And if 32 babies in 10,000 doesn't feel like a high risk situation to that woman, she can make a decision rather than only having the information about the doubling every week.
Hannah:
[23:26] And she might want to think about it, start to think about it in the terms of like three and a thousand, because that then becomes easier for us to comprehend. And then she might think about that and then we might have that conversation with her about other risks that might take that risk back so is she a fit healthy young woman with no issues her mother went to 42 I went to 42 weeks with all my babies it's my norm so was that the picture is there anything else we should be worried about the where the place that you see the biggest jump is between 41 or 42 weeks. So, when we talk about doubling, we're talking about doubling from, say, 17 per 10,000 to 32 between one week of 41 and 42. So, I think increasingly as midwives and as obstetricians, we really do need to have that serious conversation about, well, these are the risks. Now, what can we do and how confident are we that that baby is going well? And the mother can tell us a lot about that. But also, this is where we might recommend an ultrasound. So that we know that the lichol volume is good, the fluid around the baby's good, the flows are good, the baby's moving well, the mother feels confident and there'd be no changes in movement. And then based on that, she makes a decision about what's best for her, not what's best for us, what's best for her.
Mel:
[24:45] And I think there's such a big leap of, ooh, there's an increased risk of something, let's get the baby out. But there's no, and I think also what you highlighted is the importance of an individual clinician speaking to an individual woman and together working out what her potential individual chance of a complication might be. Rather than just blanket giving all the women the same stats and all the same information.
Hannah:
[25:13] You're absolutely right. And the best way to do that is to have a relationship with that woman and have continuity of care because you have an evolving discourse with that woman. You know what's important to her, what matters to her, what her fears are, what her family history is. You know, at what point is this not feeling safe for her? And you go on the journey with her as opposed to a stranger sees you here with one agenda, another stranger sees you here with another agenda, and no wonder women just go, for goodness sake, get this baby out of my body because clearly I'm such a hazard to my baby and I just can't handle it anymore.
Mel:
[25:49] Yeah, and we will read, you know, when we go through the SWEPIS study that they concluded that induction should be offered to women over 41 weeks, but what they didn't conclude, which they also could have concluded from this study, is that women between 41 and 42 weeks, would benefit from increasing their maternity care and surveillance of their pregnancy. That could have been another completely legitimate outcome or conclusion from the SWEPIS study, but they chose to recommend induction instead of recommend more intense maternity care.
Hannah:
[26:20] So we're doing all of this with absolutely no knowledge about what are the long-term implications. Yeah. And that's the thing that I find most horrifying. And we are doing all of this and we have got no idea what we're pushing out the other end into the future.
Mel:
[26:37] Yeah. Well, let's get into the trials. So we did 35, 39. Do you feel like, yeah, that's a good... Did you arrive?
Hannah:
[26:43] I think arrive is... Really? Because everything kind of, from my perspective, it's a bit like there was the pre-term breach trial and there was the post-term breach trial world. It was like a moment in time. And I remember when we were one of the sites at the time for the term breach trial, and I remember the head of obstetrics coming down before the publication came out and said, that's the end of breach. It hadn't even come out, but we were one of the sites and they'd been early insight into what the results were. And then, of course, since then, we've had loads and loads and loads of re-looking at this and saying, well, there were a whole bunch of things with that that were really problematic.
Hannah:
[27:19] And I feel like there was the pre-arrive and there was the post-arrive. So I think the arrive is really key because the arrive asked a question which kind of may seem extraordinary to us, but America would allow this sort of research to happen, which was if you took very low risk first-time mothers, and I'm talking they were super low risk, and you randomize them to having an induction at 39 weeks or waiting until 40 plus five days, right?
Hannah:
[27:51] Would you lower the perinatal morbidity, which was a composite of several different morbidities, like meconium aspiration, a really low APGA, the baby having indications of some sort of brain injury, special care for a long, neonatal care for a long time. So it was a composite. They put it all together. And the first question I always ask everybody is, why do you have to put all these things together?
Hannah:
[28:15] And the reason is because they're so rare. You can't just look at one. You won't have the numbers. It would take such a massive trial. So, first thing is they're really, really rare. So, they looked at a composite outcome that included death and all of these complications. And they randomized a good number of women, 3,000 women to induction and 3,000 women to waiting. And they had depowered the study on those numbers for the primary outcome, which was that composite outcome.
Hannah:
[28:41] And they found there was no statistically significant difference between the primary outcome for the babies, right? So it was 4.3 versus 5.4, which may sound like there's a difference, but it is not statistically significant. So in research, pure research terms, we say there was no difference. But their secondary outcomes included an outcome on cesarean section. And they showed in this that the cesarean section rate in the induction of labour arm was 18.6 versus 22.2 in the waiting arm. So instantly, because it didn't show any benefit for the baby, the headlines were all induction of labour lowers caesarean section. And I find it fascinating that, you know, obstetricians often aren't too worried about caesarean section rates as long as they... Other intervention they really want to do can be sold as reducing those cesarean section rates. So it's quite fascinating how that became the headline and a reason to induce everybody at 39 weeks.
Mel:
[29:49] Yeah, let's reduce the cesarean section rate by doing an induction. It won't change outcomes for babies, but it could lower our cesarean section rate. Yet, if there was a study, and there is, studies that say having your own midwife as a continuity of care provider would reduce your rates of cesarean section, I mean, that's not sexy, is it? It's not sexy like, hey, this intervention prevents this intervention.
Hannah:
[30:16] It's not a machine that goes wing. But it even gets more bizarre, the arrived trial, because only 27% of the women approached agreed to be in it. Which tells you straight away this is not an acceptable thing to the majority of women. Only 6% of those women were cared for by midwives. 94% were cared for by private obstetricians who were not blinded to the intervention.
Mel:
[30:38] Oh.
Hannah:
[30:39] They knew these women were either randomized to an induction group or not. Now, it's very hard to blind an obstetrician to, okay, your woman's going to get induced. You can't, you know, go around knocking them on the head and do it behind their back. So it is a very hard thing to blind to. But they knew the group they were randomized to. And the recommendation that came out said is cesarean could be avoided for every 28 planned inductions. So that was kind of the headlines. But my argument back to that is if you look at the Warren Cochrane Systematic Review of support during pregnancy and birth by a doula or another person in that labor room, we know one cesarean can be avoided for every 14 women who have continuous support and aid, just as you said, Mel. So why was the recommendation not every woman needs to have continuity of care and a doula or somebody else that's in the room with her all the time? Why was it always about doing more, not everything? Being with women more as a relationship. It's fascinating stuff.
Mel:
[31:43] Yeah, I mean, and so they're running with the ARRIVE trial less about, hey, if you're getting induced at 39 weeks, we can keep your baby more safe and more with the line of if you have an induction, you're going to reduce your chances of a cesarean section, really, though, with a private obstetrician.
Hannah:
[32:02] Yeah, and keep in mind, super low-risk women having cesarean section rated between 18% and 22%.
Mel:
[32:11] Yes, I know, right?
Hannah:
[32:12] It's quite shocking. Wait till we get into the SWEPUS and the INDEX trial and you'll see how shocking that actually is.
Mel:
[32:21] Well, I mean, this also highlights a lot of the problems with the maternity care system, full stop. Why is a low-risk woman, even who doesn't have an induction, 22% chance of having a cesarean infection? I mean, it's ludicrous. There's so many things that are ludicrous that it's highlighted. But the ARRIVE trial itself is not an endorsement, I suppose, for the life-saving possibilities of induction.
Hannah:
[32:49] But none of these are. If you look purely on their primary outcome measure, none of these five trials are. So they will all show differences because, of course, we will show differences. But when we set a power for a study in a sample size, we do that based on this much of a difference we would have confidence in saying that that's statistically significant. And if it's not that much of a difference, it's not, and therefore it is not considered an effective intervention.
Mel:
[33:20] Well, a lot of women are being sold induction as a way of avoiding stillbirth, though.
Hannah:
[33:25] Absolutely, because we know about this doubling that happens at every week. And so we're desperate to find a solution. I mean, one of the sort of ways I explain it might not be a good way is that my risk of death goes up every year that I live. But I'd rather be alive, old and have a high risk than I would be to curtail my life just so that I don't end up with that risk of having a more likely to have a death. So, you know, there is a certain, you know, I examined something the other day and the person had said that there were women with high risk and no risk. You do not exist if you don't have risk. We do not have no risk. You have the moment the egg and the sperm meet and implant in that uterus or even before there is risk. How much risk women are willing to accept and how much risk are their individual circumstances potentially going to lead to? Our job is to give them the information. It's their job to decide what risk they want to accept.
Mel:
[34:34] Yes, this is what we're hoping to do today. Give women information so that if their clinician says, well, the arrived trial said, well, the surface study said, well, you know, that you can assess this stuff for yourself. Are you getting ready to have a baby? And if you are, what are you going to do about the pain of contractions? There are lots of things you can do. In fact, I'm going to tell you about them because I've been watching women give birth without pain relief for over 18 years. I'm Dr. Melanie Jackson and I'm a home birth midwife. I had my own babies at home without pain relief and I've been helping other women do the same for my entire career. If you want the top tips and tricks that I recommend to help women give birth without pain medication, it's all here in the link below in my guide to giving birth without pain relief. You can do it. Give it a go. Why not just prepare?
Mel:
[35:28] So that's the 35-39 trial and the ARRIVE trial. Where to now? Index. Index.
Hannah:
[35:35] Let's go to INDEX next, and that's the good old Dutch. Now, this was actually quite a nicely done trial. I mean, and I have to say all of that, this is no comment on the methodology. The methods of each of these trials are done very, very well. These are very trustworthy research trials. So they've done well. They adhere to all of the best scientific principles. So this is not rubbishing in any way the research undertaken. It's not rubbishing anything, but it is asking questions about how they present it. So, the Dutch trial randomized 1,800 women around 1,800 low-risk women in midwifery practices, yes, to induction at 41 weeks or expectant management up to 42 weeks. Now, in the Netherlands, you know, going to 42 weeks was quite normal.
Mel:
[36:23] So, this is a post-dates study.
Hannah:
[36:25] This is essentially a post-dates, whatever that is now. It seems to be, you know, almost if you exist, it's post-dates. Yeah. And it was both multiples and primates. So it differs from the ARRIBE, it differs from the 35-39 trial. 60% of the women... Declined to be in the study. So I want people to keep in mind how many women are saying no to these trials. The gestational age difference between those two groups was two days, 41 plus zero compared to 41 plus two. So tiny differences in how far advanced women were in the two groups on average. They set up a primary composite measure. Again, as I explained before, lots and Lots of things that are not good for baby outcomes were put together and there was no difference in the primary composite outcome and it was really low. It was 1.7% versus 3.1%. Now, that looks like it's a doubling. It's a double. It is a double, but these are tiny, tiny percentages that didn't reach statistical significance. There was no, and I repeat, no difference in the cesarean section rate between the two arms and the caesarean section rate between the two arms was half that of ARRIVE with post-dates women at 10.8%.
Mel:
[37:43] What a difference a location can make.
Hannah:
[37:45] And a model of care with midwives.
Mel:
[37:48] The ARRIVE trial, just to reiterate for people listening, the ARRIVE trial was predominantly the women were cared for by private obstetricians. It was a small percentage cared for by midwives. But in the INDEX study, they studied women who had continuity of midwifery care, and the rate of cesarean section was more than halved then or about around halved when you're, under midwifery model of care, whether or not you had an induction or not.
Hannah:
[38:15] And they were theoretically two weeks on in their gestation from the American trial. And any other outcomes they looked at, like APGA scores less than seven at five minutes, that was slightly different, but not at four. So it was slightly better in the induction group, but not when you looked at less than four minutes, which is what I think we should look at because we all know less than five at seven minutes isn't very accurate. But the primary outcome was the composite measure and it was not statistically significant. I reiterate, not statistically significant. That is the key here because to say anything else is not to be true to the science of that.
Hannah:
[39:01] Do you want to talk about Swedish study? I love a good study.
Mel:
[39:04] Let's talk about the Swedish study. So, that's the SWEPAS study.
Hannah:
[39:08] SWEPIS study.
Mel:
[39:08] Right. Okay. So SWEPIS study. Let's do that next because this is the one where I was really disappointed with how they wrote the paper really. I think that the research was presented really beautifully and you could see the process that they went through. You could see their findings, but then the conclusions really spoke to what they wanted the study to stay rather than what it said. So, yeah, let's do the SWEPIS study.
Hannah:
[39:40] So, again, the SWEPIS study had hundreds and hundreds of women randomized to being induced at 41 weeks or waiting up to 42 weeks. It involved two regions in Sweden, involved 14 hospitals. It was beautifully done. It was a randomized controlled trial. Again, I just want to reiterate, 77% of the women refused to participate. So again, we come back to this generalizability. It was a mixture again, like the INDEX study of multiples and primates. The gestational age difference was four days in this, so 41 plus three compared to 41 plus seven days. So amazingly in Sweden, that was very standard to go to 42 weeks. It was not a big deal. Primary composite outcome again for the baby. So remember that mixture of all those things we don't want to happen to babies put together was 2.4% compared to 2.2 percent. It was not statistically significant and it was really low. So looking at all of that, you go, wow, well, what's the problem? Well, this is what happened.
Hannah:
[40:51] Because there were six deaths of babies in the expectant group, the group that waited on until past the 41 weeks, and none in the induction of labor group, they closed the trial early. So that meant that they didn't have big numbers. They stopped early. They didn't recruit everybody. They ceased the trial. And they ceased the trial because they said, well, this is an adverse event. We can't, in good conscience, go on recommending something when we know, looking at this, that we should recommend induction at 41 weeks.
Mel:
[41:28] This is not this similar to what happened with the term breach trial, right?
Hannah:
[41:34] Yeah.
Mel:
[41:34] Was it five babies or six babies? I thought it was five.
Hannah:
[41:38] Six. But this is what's so interesting. And when I talk to my Swedish colleagues, they're quite fed up with what happened. What happened was there were none in the Stockholm group of women. So there was sort of divided up into about 500 of them were in the Stockholm group and then the rest were in the other centers. So it was about 557 in the Stockholm group and then there was about 822 or something in the other centers. All the women in the Stockholm centers were offered routine ultrasound at between 41 and 42 weeks. Everybody had it. And so they knew when to really recommend induction and pull them out of the trial or not pull them out of the trial, but to say, well, actually, no, I know you're an inspector now, but you really need an induction. In the other centers, they didn't do routine ultrasounds. So... What my question is, exactly what you said at the beginning of this podcast, why was the recommendation not made that actually we should be recommending ultrasound at 41 weeks to decide who are the women that can proceed most safely beyond that and who are the women that we should really encourage to have the induction? But the conclusion was induction of labor ought to be offered to all women no later than at 41 weeks and could be one of the few interventions that reduces the rate of stillbirths.
Mel:
[43:04] Meanwhile, if all the women who'd had ultrasounds in the arm that was going to go to 42 weeks, there was no stillbirths either. And so that's why I was saying you could just as easily have said, well, we acknowledge that there is an increased risk of stillbirth between 41 and 42 weeks. There are a number of possibilities. There are a number of options that women could choose to reduce that chance. You could choose an induction. That's what you wanted. You could choose to have increased surveillance, acknowledging that risk and seeing if we can counteract it.
Hannah:
[43:41] It's even worse than that, Mel, because it was not powered to show a difference in the stillbirth. So we can't even say that it reduces your risk of stillbirth. We can say that as a generalized statement. We cannot say that as a statistical statement. Because it was not powered to show a stillbirth because so few stillbirths happened, you would need much bigger numbers, but they stopped the trial before. So, for example, you might have had those six stillbirths and then for the next thousand women that got recruited or got brought into the trial, there might have been absolutely zero stillbirths.
Mel:
[44:15] But then there could have been six in the induction group.
Hannah:
[44:17] Could have been six in the induction group, could have been another six in the waiting group, and then we would have had even better evidence that actually that is even a better recommendation than the one they made, which was with the limited information we have, we're going to recommend that. What I did forget to say is that in the INDEX trial with the Dutch study, they also had this, I think, very clever approach where they randomised women who agreed and the women who didn't agree, they put them in a cohort study. It was about 3,000, I think, of those. So they would just say to you, well, what do you really want? No, I don't want to be induced. Yes, I really want to be induced. And they would just follow them through and see what happened under natural circumstances. They were absolutely zero still births in that cohort study.
Mel:
[44:59] Well, they did a similar thing for the Big Baby study.
Hannah:
[45:01] Ah, they sure did.
Mel:
[45:03] Because, yeah.
Hannah:
[45:05] No, no, it was slightly different. Shall we get on to the Big Baby study?
Mel:
[45:09] Let's do the Big Baby study. This is the newer one. And there's not a lot of commentary on it yet. I mean, there's a little bit because it landed really, really recently. Yeah, and I saw that and I was reading that, that the women who declined to be a part of it, they still kept an eye on them.
Hannah:
[45:24] No. So what happened is that it was a randomized control trial looking at induction of labor versus standard care to prevent shoulder dystocia in babies who were estimated to have a fetal weight above the 90th centile by ultrasound. And that ultrasound was anywhere between 35 weeks that was done and 38 weeks. And then based on that ultrasound, they were randomized to either be induced, so 2,800 of them were randomized to be induced between 38 plus zero weeks or 38 plus four weeks, or they were randomized to be in standard care and weight. So the aim of this study was to reduce shoulder dystocia
Hannah:
[46:12] By inducing early, baby's estimated to have a fetal weight of greater than 90 centile based on ultrasound. We know, you know, shoulder dystocia is increased. So what, just for those who don't understand what that is, that's when baby's head's born, everybody's like, this is nearly over and whoops, we can't get the shoulders out. It is more likely with bigger babies. Doesn't always happen with bigger babies. Can be completely unpredictable. And so what they were trying to do is take the group where it's more likely, which is larger babies, and see if there's anything we can do to reduce it. Why a shoulder dystocial problem? Because babies, once they put their little heads out, they're running, starting to run on a different circulatory system, and it is a countdown to them being affected by the lack of oxygen. So it is an emergency. But the ones that I have been a part of, very little of that was predictable. They were really out of the blue when they happened. But their aim is to try and say, okay, we can now try and predict a group that we can reduce it with. So they randomized. What they wanted was 4,000 women because they needed so many women to get a difference in a really rare outcome.
Hannah:
[47:27] But they stopped it early because, not because the outcomes were terrible for women who waited, but because they had a lower than expected incidence of shelter dystocia in the standard care group. And so they could have gone on for a thousand years almost and probably not shown a huge difference.
Mel:
[47:50] I'm so glad you said that because honestly, when I read this paper, I'm a seasoned researcher. You know read papers I've done a PhD you and I have written papers you know we've researched together, and I thought why is this paper not making sense I'm a little confused okay they stopped the paper, because the standard care group so the women who weren't being induced had such a low rate of shoulder dystocia that they felt there was no need to continue.
Hannah:
[48:23] So it's a little bit more complicated in that they worked out what the rate should be, and then they worked a power sample out of how many women needed to be randomized to get a significant difference. But the rate in this group, both sides, was so low, they didn't have enough numbers, and it would have needed thousands of women to be able to confidently say that this makes a difference or not. So they stopped it. Now, there's nothing wrong with that in that you're not putting people through unnecessary interventions. You are reducing your cost of really expensive research. This costs millions, these sort of studies, right? So there's nothing really wrong with that as long as you conclude the rate of shoulder dystocia is so low that inducing women at 38 weeks is not going to make any difference if their baby weight is estimated to be greater than 90th centaur.
Mel:
[49:17] So basically they were saying, let's not waste our time. Let's not waste our money. Let's not apply this intervention over and over again. There's no way we can enroll enough women to get the answer that we were trying to study. So let's stop the study. However, they still published the paper to say what they wanted the paper to say, what they were hoping to find out from the paper, from the research.
Hannah:
[49:42] Well, what they did is they published the paper with the intention to treat analysis, which is what you do with a randomized control trial, which means if I say to you, you agree, Mel, to be in my study and I randomize you, randomly allocate you to induction, and then I randomly allocate somebody else to waiting. But at some point you end up waiting because you decide to change your mind on that and this other person decides to be induced. Instead of sticking you in the group of induction or waiting, you stay in the group you were assigned to. So this is a really important part of a randomized controlled trial. It's called intention to treat. You analyze by the intended at the outset group you were meant to be in. It's a really important part of a randomized trial. So they analyzed it two ways. Yes. They analyzed it as intention to treat and then they went, okay, Mel, you were meant to have an induction. You chose to wait. I'm now going to take you out of that induction group. I'll put you in the choose-to-weight group. I'm going to analyze you in that. So they did two separate analysis on the same data, which led to two separate conclusions.
Mel:
[50:52] So to people reading the paper, the way they've set it out is they'll tell you the results of the intention to treat analysis and they call the other one the per-protocol analysis.
Hannah:
[51:03] As per protocol. As per protocol.
Mel:
[51:06] And this is what I just felt like there was handstands and cartwheels done in this study which made it so hard to follow. So you're saying the intention to treat analysis is the usual way that a randomized control trial would be analyzed? Yeah. And in the intention to treat analysis, what they found was.
Hannah:
[51:28] Nothing to report the heart of a randomized trial is at the end of the day when we look at all of the demographics of people their ages their education their morbidity they should look exactly the same the only thing different with them is the intervention they had whereas in intention to treat you've got that whereas per protocol if Mel says to me yeah you randomized me to induction but I really wanted expectant management I really wanted to wait so I'm just not going to agree now. You have certain sets of beliefs that are making you want to go a certain way. So now your population is not exactly identical.
Hannah:
[52:04] So the intention to treat analysis was that the rate of shoulder dystocia was 2.3% in the standard care and 3.1% in the induction group. And it was not statistically different. And there was about six days difference in gestational age between the two groups. But here is the interesting thing. This is where I've often said that I feel like for the last 35 years of my midwifery career, I've been watching the naked empress striding past and everyone telling him how beautiful his outfit are. And I've just been crying, bullshit, you're naked. So this is the bullshit, you're naked part of the emperor. The difference in baby weight between the two groups was 163.6 grams to be precise. The average was 3.693 compared to the, that was the average grams compared to 3.8. So tiny little difference in numbers. The induction rate in the group and allocated to induction was 91.7%. So there were some women who birthed quickly and didn't need to be induced, but The induction rate in the waiting group was 70.6%.
Mel:
[53:16] Oh, how did I miss that when I read it? So even the ones who were in the waiting group, 70% of them got induced. So we aren't really truly comparing the rate of shoulder dystocia.
Hannah:
[53:30] You never are. In any randomized controlled trial, there will be some that actually follow the intervention, some that don't. Because, for example, you're waiting, but now everyone's super concerned about how big your baby is and you get induced any. All right? So the intervention was pretty high in that group. The emergency cesarean section rate, because anyone who wanted a cesarean was out, the emergency cesarean section rate was 25.7 versus 28.8. So the cesarean section rate was a little bit lower, but not a huge amount. But this is what's really interesting. Remember, the reduced shoulder dystocia is the primary outcome, didn't show a difference. But why do we want to reduce shoulder dystocia? Because we want to reduce morbidity to the baby. So let's look at morbidity to the baby. There was one neonatal death, which was due to asphyxia, which is due to the lack of oxygen in the group that was randomized to weight. And there was one in the induction of labor group, which was due to sepsis and pneumonia, one in each group. There was no difference in neonatal outcomes like neonatal intensive care admission and readmission after 30 days and then at two and six months there was no difference in the babies there were two incidences of what we would call hie
Hannah:
[54:57] Which is where there's bleeding into the baby's brain that can be associated with cerebral palsy two of those in the induction of labor group none in the other group there were no breaking of the baby's arm or breaking of the baby's clavicle which are some of the things we have to do sometimes in a shoulder dystocia in either group. The other big risk of shoulder dystocia is what we call brachial plexus which is when we end up with permanent sometimes nerve damage which will lead to an arm being less able to be used or unable to be used. There were four incidents of brachial plexus in the induction of labour group
Hannah:
[55:35] Two associated with shoulder dystocia, one serious and requiring surgery, but not associated with shoulder dystocia. Two in the group that were waiting, not in the induction group, one with shoulder dystocia and one not with shoulder dystocia. And in all groups, there was nothing permanent. There was no permanent injury. So the brain injury, the fractures, the nerve damage, absolutely no difference. And I think what's really interesting is some of these things occur whether you have shoulder dystocia or not, like brachial plexus injury can. Prematurity associated problems like needing to have blue lights because your baby was jaundiced or needing to have ventilation was 6.2% in the induction group and 5.3% in the standard care group. Absolutely no difference. The readmission of the baby within 30 days after birth, 13% in the induction group, 11% in the standard care group. Absolutely no difference at all in the damage to the baby.
Mel:
[56:45] Yeah. We're still, this study still can't give us definitive information about, if induction of labour early is an appropriate intervention to reduce shoulder dystocia for suspected big babies. And that was another interesting thing that the researchers reported on. They reported that a limitation of their study was that their estimated fetal weight ultrasounds have very poor predictive value. So they did check. They checked, okay, which babies are over the 90th centile based on their scan, and those are the ones in the induction group that got induced. But what they found was that only 42% of women in the induction group, had a baby that was actually in the 90th centile. So 58% of those babies were induced for being suspected to be big, but they weren't big. And that was very similar. Sorry.
Hannah:
[57:50] And 40% in the other group. So essentially what, let's reframe this and say 60% of women did not have a big baby following the ultrasound that said they would.
Mel:
[58:00] Right. So the ultrasound that said your babies over the 90th centile, only 40%, were correct in a sense that overall 60% were not. They said, actually, the test that we do to find out the information that decides whether or not we should do this intervention is so wildly inaccurate. And I mean, this is the conclusion of the Cochrane Review as well, when they looked at should we induce women, one of their issues is that, well, we can't really induce women for big babies because the methods that we use to discover big babies are so inaccurate.
Hannah:
[58:40] So poor. And not only was there no difference, not only was the technology to identify the baby's score, not only was there little difference in the birth weights, and clearly many of them were not big babies. But the most shocking part of the Big Baby study is, and I'll never let the truth get in the way of bias, that's for sure, that for clinical practice, the findings provide support for the concept that early delivery reduces the risk of shoulder dystocia for a baby. Suspected to be large for gestational age and clinicians can be reassured that compared with waiting, expected management, a decision for earlier delivery is a viable option and the study also shows that earlier delivery does not need to be before 38 weeks gestation to obtain this benefit of which there was no benefit.
Mel:
[59:36] So how did this stuff get published? I mean when you have the study so most to be honest most people who want to believe the Big Baby study will read the conclusion and run with it and that's what they'll tell their clients and their colleagues and they'll go great yeah right let's reduce the shoulder dystocia rate, because they read the conclusion but they will never and and many people are unable to even interpret these studies and, And as I said, I know how to read a paper, and this one was not easy to read because of the gymnastics that they did back and forth between all the different types of analysis and then this wildly inaccurate conclusion.
Hannah:
[1:00:21] But it gets better, Mel. If it just stopped there, we'd all be going, what the hell? But they did a cost analysis, which is a really good thing to do. The cost of inducing as opposed to waiting. And they had some very clever economists on. and I have no issues with their methodology. The recommendation from that was, the conclusion from that was that early induction of labour increases neonatal care costs, right? It causes more costs because of more babies needing neonatal care. It is not cost-effective when you restrict this to maternal quality-adjusted life year indexes. It's what they use to work this out. But why not just stop there and go it's not cost effective and it shows no difference so let's have another think and let's get more accurate on our ultrasound no no they then said planned cesarean section might be cost saving when compared to early induction
Mel:
[1:01:20] Yeah do you know they also said because i had look at this and i correct me if i'm wrong but the cost of preventing one case of shoulder dystocia, 11,879 pounds when they did the cost analysis.
Hannah:
[1:01:36] Yeah. But they did. I mean, at least obviously it got reviewed or they had enough humility and good research knowledge to say that we didn't assess longer-term effects, such as the increased risk of repeat caesareans. We didn't assess longer-term effects on the mother and the baby, and that should all be done in the future. And this is where we actually come to the big crutch, which is we do not know the ramifications.
Hannah:
[1:02:07] We barely understand how labour starts and what goes on in here. We know more about landing a man on the moon than we do know about the process of starting labour in a woman's body. And I've always said that, you know, if men had babies and women landed on the moon, we'd probably know more about the babies but we we know the disturbance of the microbiome has potential effects on on the child we know that the use of oxytocin has been shown to have some effects on women's mental health post-birth we know epigenetics is a absolute factor there and endogenous and endogenous that's it the synto we have in our body or the oxytocin we have in our body is very different to the synthetic stuff they work in different ways we know that a lot of women with intervention and long labors, which are inductions often, are ending up with antibiotics. And we know the impact of that on the baby. And we know from our research that we've done for the BEST study that women are often, more than any other mode of birth or any other intervention, they are traumatized by induction. And when we looked at the BEST study, we asked women, what would you do differently? And then we looked at the women who said induction.
Hannah:
[1:03:24] They would avoid it. Over 500 comments were around induction and they said the number one thing was they would not agree to it again unless there was a very good reason and they do everything they can to try and await spontaneous labour. So we're not even, you know, we're not even considering all of the sequelae while we're making these confident decisions, confident recommendations based on data that tells us that we're not correct in what we're recommending.
Mel:
[1:03:54] And also the fact that it's an unacceptable intervention for many women, well, not only to the ones that declined it during the randomization process for all these studies, but then when women do encounter and go through an induction, so many will say, I'm not doing that again. So these papers are promoting the use of this unacceptable to many women intervention. And I do believe, though, that women will accept things if there's clear indication, clear reason to do things. But these papers aren't offering that. They're not offering a clear indication. And then it's really hard to take anything seriously when they're making just whatever wild conclusion they want to make. You know, even with the Big Baby study and it doesn't even relate to the findings.
Hannah:
[1:04:50] I mean, both WHO, despite these studies and NICE, and of course, nobody's caught up with the Big Baby study because it's only just come out, have both recommended that induction of labour be discussed and recommended to women from 41 weeks onwards. So, despite the ARRIVE trial, despite all of these studies, the recommendation is still 41 wins. And that that should be discussed with a woman, that the alternatives should be discussed with a woman, that she has time to think about it, that she has time to discuss it, she has time to seek other opinions. And in the end, whatever she decides is respected. Now, if we put that in place, I think those are very good recommendations. But then we should be saying to women, well, You know, this might be a real good time to have an ultrasound as much as they are unreliable for baby weight. They are very good at picking some things up like the volume of the water and whether the blood flow is good and the placenta is working. So let's do that. Then we can have that bit of information to then have more discussions so that when you make that decision, it's truly informed. So we've got to work out ways of giving this information honestly, accurately, early enough and with enough space for women to reflect, to think, to seek other information, to ask questions and then respect that decision, whatever that decision is.
Mel:
[1:06:10] And also manage the alternative appropriately. So let's say the woman declines induction after all of that education and maybe she's been given a recommendation to be induced. She says, no, I don't want one. And they go, well, good luck instead of going okay so you've declined the induction here is something else we can do to mitigate this risk we've just spoken to you about maybe let's have a few more appointments maybe let's have an ultrasound, you know there's so many other options to being induced and I don't think women have to choose, waiting and seeing and just sitting there and waiting and an induction I think, In between there, there's maternity care.
Mel:
[1:06:56] Yeah, women are clever enough to make decisions about whether or not an induction is appropriate. And I've had that in my work as a private midwife. I can recall two times, and I do that every woman who's over 41 weeks, I invite them to have an ultrasound if they want. And in two circumstances, the ultrasounds had changed significantly from the 41 week one to the, you know, when they took over 42 weeks and you sort of go, let's have another ultrasound. You're over 42 weeks now massive difference in the chain in in the well-being of the baby, and when you sit there and you say to women i'm more than happy for you to go, over 42 weeks but now we can see your baby your particular baby's not, showing signs of not coping with this scenario and it looks like your baby needs to come out what do you think and of course both of them who are already planning a home birth said i would gladly have an induction for this reason and, And so, I just think it's not the cut and dry of you have to sit and wait or you have to have an induction.
Hannah:
[1:08:01] I totally agree with you, Mel. I think the other thing that we need to be aware of, and this is from the best study that Hazel and I have led, is that when we ask women, you know, if you knew then what you knew now, would you make the same decision about having an induction? You've got 40% of women saying they would not make the same decision. So, that's 40% said they wouldn't. Around a third said yes, they would. And about, you know, 25%, 24%, 25% said probably. Probably. So, there's not a resounding endorsement. And then when we looked at the birth trauma rates, the birth trauma rates was double for women who were induced compared to spontaneous onset. This is not something they like. This is not something they are often feeling that they have choice. We also asked them whose decision it was made. And, you know, whether they made the decision or whether the care provider made the decision or whether it was a joint decision. And you only had about 40% of the women who said it was a shared decision, but another 40% who said it was mainly their care provider's decision. So we're clearly failing women on providing information that enables them to make informed decisions as to what they want to do.
Mel:
[1:09:20] Yeah, and I think that's the big thing here is that then, even if they are given information, it could be one of these five studies and they're not really getting information.
Hannah:
[1:09:31] And you've got obviously healthcare providers, you know, particularly doctors, getting all of the studies mixed up. So they're giving, they're literally taking the five studies, putting them in one big pot, doing a stir and going, well, this says this because that's what I actually want you to do at this point.
Mel:
[1:09:47] Yeah. And that's why I think, you know, that's why we put all these studies in the resource folder as well. I do think if you're out there looking to, you know, if your clinician has said, well, based on the big babies trial or based on the ARRIVE trial or whichever trial it is, I'm recommending that you do this. There's enough information out there for you to spend the afternoon reading and understanding what these studies are saying and seeing if it relates to your circumstance. Amazing Hannah, thanks for breaking that down because five of these big studies, I mean we could have, I think we could have done one at a time, you know there's enough information but you've really picked out the important elements.
Mel:
[1:10:28] What I'm hearing is that there really isn't enough evidence yet to conclusively say that, women are going to have better outcomes if they're induced for big babies, later babies, if they're over 35. It's possible. I mean, we know, yes, the longer you're pregnant, then the increased rate of stillbirth in the statistics that we spoke about, small increment increases but is induction of labour the solution to this problem? The answer is not. Revealed for that yet.
Hannah:
[1:11:06] I think, and I agree with WHO and NICE on this, that recommending induction of labour after 41 weeks is a wise decision because probably the benefits outweigh the harms. But if that's something unacceptable and I would have said no, there's no way I want it to be induced, then I would like to know that I can actually have a ultrasound, which will give me a bit more information so I can make that decision. So when it comes to routinely inducing low-risk women at 39 weeks, no, we don't have the evidence on that. And we have no long-term evidence. When it comes to women over 35 being induced at 39 weeks, no, we don't have the evidence of benefit for that at all. And when it comes to big babies, estimated fetal weight greater than 90 centile being induced at 38 to 38 plus four, between 38 and 39, we don't have the evidence of huge benefit. So I think that's what we can say from this. And in the end, the decision is the woman's.
Hannah:
[1:12:09] And she lives with that decision, whether it's birth trauma because of an induction that she never actually wanted, whether or not it is an adverse outcome for her baby. There is, it's kind of tough for women. They grow this little one in their belly. They're almost burdened with all of the decision making. And I guess I would just say to women, you don't have to shoulder it all. We can share it with you. You know, lots of discussions. We can go through lots of information and we can find out what matters to you so that when you make that decision, you feel heard, you feel informed and you feel respected. And if we can get that right, we will get safe and satisfying birth outcomes.
Mel:
[1:12:51] And then the big problem is, is the majority of women don't know their care provider. They're getting fragmented care, short appointments, and clinicians who aren't providing the care that you described. And in that scenario, women are left to either just accept the care that's been recommended to them because there's not really room for a conversation. The clinician might not be invested in what the woman particularly wants. So it's really challenging for women to make decisions when they potentially don't even have access to the care providers that they're supposed to be asking for information from. I think a lot of the problems that are happening with the increased induction rate and the hardship that women have in making the decision are that women don't have continuity of care.
Mel:
[1:13:43] And I think if you want to not have an induction or be offered the opportunity to have respectful conversations around your choices, I do really feel like continuity of care with even a trusted obstetrician who is on your side and who, is aligned with your philosophies, midwifery care program, a private midwife, somebody who knows you, who you have time to have the conversation with. Because this isn't a five-minute conversation. It's not even a one-hour conversation. You know, in the times that I've recommended induction to women, it's hours of information, emails back and forth, phone calls, extra questions that weren't asked in the first appointment. There's a lot to consider. So...
Hannah:
[1:14:27] Can I just make a comment on that? It's also not one conversation. That's the decision and, you know, forever hold your peace. It's an evolving conversation that will be happening today, differently to tomorrow, differently to next week. And we need to constantly have that conversation. And there's a fine line between battering them into making a decision that we want and making sure that they feel like they're heard, that we have taken into consideration all of the changing clinical picture and that we've given them options. And that's exactly what the Women in the Best Study show. We've just published that paper this year where we asked them what they do differently and just looked at induction. And 93% of the comments were around the theme that they wanted to increase the chance of a spontaneous labour next time by resisting induction.
Mel:
[1:15:16] Yep.
Hannah:
[1:15:16] That's what they wanted to do. They didn't know they'd never have it, but they wanted to resist it and increase the chances of a spontaneous labour.
Mel:
[1:15:24] So it's, yeah, I just think a lot of the problems that we're encountering now could be solved with relationship-based care.
Hannah:
[1:15:31] It's the number one thing, Mel. I mean, if we could just get that right, we could get so much of what we've got wrong right.
Mel:
[1:15:39] And that would be probably my take-home message for women in this podcast. I'm like, man, this is the landscape. This is the research that's informing a landscape. And if you could do nothing else for yourself, I would suggest... Doing your utmost to find a continuity of care provider who's aligned with your philosophies, who you feel you can have these conversations with. Thanks, Hannah.
Hannah:
[1:16:04] My pleasure.
Mel:
[1:16:05] Been a pleasure, as always. To get access to the resources for each podcast episode, join the mailing list at melaniethemidwife.com and to support the work of this podcast, wear the rebellion in the form of clothing and other merch at thegreatbirthrebellion.com. Follow me, Mel, @MelanietheMidwife on socials and the show @TheGreatBirthRebellion. All the details are in the show notes.
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