Unethical Swedish researchers shocked that deadly research led to dead babies

Grunge Textured UNETHICAL Stamp Seal with Ribbon

According to The Guardian:

Sweden has cancelled a major study of women whose pregnancy continued beyond 40 weeks after six babies died.

The research was halted a year ago after five stillbirths and one early death in the babies of women allowed to continue their pregnancies into week 43.

“Our belief is that it would not have been ethically correct to proceed” with the study, the researchers concluded.

Not only would it have been unethical to proceed, it was unethical to undertake the study in the first place. The death of babies was not merely preventable; it was inevitable.

Swedish researchers withheld the known preventive treatment for postdates pregnancy deaths to see what would happen.

Why is the study itself fundamentally unethical?

Swedish researchers withheld the established preventive intervention for postdates pregnancy deaths to see what would happen and — not surprisingly — babies died postdates pregnancy deaths. That type of study is never ethical and no informed consent procedures can ever make exposing patients to preventable deadly risks ethical.

Their excuse?

There is no international consensus on how to manage healthy pregnancies lasting more than 40 weeks, although it is generally accepted that there is an increased risk of adverse effects for mother and baby beyond 41 weeks.

But there is complete international consensus on how to manage pregnancies beyond 42 weeks; induction is the established treatment and has been for decades.

These two charts demonstrates why.

This is a chart of stillbirth rates by gestational age.

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You can see that stillbirth rates begins to rise from about 36 weeks of pregnancy onward and rise steeply after 41 weeks.

Why don’t we deliver every baby at 36 weeks? Because it makes no sense to deliver a baby early to prevent stillbirth if that increases the chance that the baby will die in the days and weeks after birth.

This chart shows neonatal and infant mortality by gestational age:

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Mortality reaches the lowest rates at 39 weeks. If we want to minimize both the risk of stillbirth and the risk of neonatal death, the optimal time for delivery is 39 weeks.

There is as yet no consensus on whether routine induction should be offered at 39 weeks, 40 weeks or 41 weeks. But there is complete consensus that all women should be induced by 42 weeks. The stillbirth rate jumps precipitously from 0.5/1000 at 41 weeks to 0.75/1000 at 43 weeks. The stillbirth rate at 39 weeks, in contrast, is 0.3/1000.

…[T]he Swedish post-term induction study (Swepis) set out to survey 10,000 women at 14 hospitals.

Women in their 40th week of pregnancy were invited to join the study and divided randomly into two groups, with labour induced at the beginning of either week 42 or week 43, unless it occurred spontaneously.

Given what we know, what should researchers have expected to happen?

If 10,000 women reached 42 weeks, we would expect 5 stillbirths and if they reached 43 weeks we would expect 7-8 stillbirths.

That was an unacceptable, unethical risk. But the Swedish researchers managed to exceed the worst expectations:

When abruptly halted in October 2018, the study had involved only a quarter of the target number of expectant mothers. But the six deaths were already judged to indicate a significantly increased risk for women induced at the start of week 43. No infants died in the group whose pregnancies were ended a week earlier.

The researchers represent their findings as a new discovery:

The immediate consequences of the study “may be a change of the clinical guidelines to recommend induction of labour no later than at 41+0 gestational weeks”, its author concludes.

Sahlgrenska hospital announced on Thursday that it would change its pregnancy management policies based on the results of Swepis trial.

“We have awaited the scientific analysis showing that it is really true that there is a greater risk of waiting two weeks beyond term,” the head of childbirth operations at the hospital told Swedish television.

But there was NEVER any question that it was true. So why did the researchers, most of whom appear to be midwives, embark on this fundamentally unethical study? Because they can’t handle the truth that interventions often produce better outcomes than “unhindered” natural childbirth.

Contemporary midwifery is at a crossroads.

The foundation of contemporary midwifery is:

1. The belief that childbirth interventions inevitably lead to more interventions, often culminating in a C-section and therefore a bad ‘experience.’

2. The quest for a better childbirth experience is justified by the fact that “scientific evidence shows” that it is also a safer experience.

Hence the crossroads. One direction would confirm the claim that midwifery is about adherence to scientific evidence; the other would represent a rejection of scientific evidence in favor of doctrine. Sadly, it looks like midwives are searching desperately for any fig leaf that would cover a naked rejection of high quality science in favor of doctrine.

To cater to their own prejudices, they embarked upon a study that — predictably — killed babies. They should be held to account for letting babies die because of their irresponsible, unethical denial of established obstetrical care.

  • MelJor

    Hey all—this is a bit OT, but I seem to remember one of the frequent commenters here is a mod on a twin pregnancy (maybe specifically mono/mono, di/mono group)? A woman I know online is experiencing what is likely the imminent loss of one twin, and her twins share a placenta. Apparently her doctors just keep telling her that “they don’t know” why or what is happening and she is looking for some support.

    • mabelcruet

      Is she UK based? We have TAMBA in the UK (twins and multiple births), they provide a lot of information and support for parents, it might be worth trying them?

      • MelJor

        I think she is in Canada. If the group is only though she may still find some support from other families who have had to experience much more complex pregnancies.

        • rational thinker

          Has she seen a high risk ob? She can always get a second opinion too.
          The thing that worries me about this is she may ask for help on NCB blogs, and someone will assure her is it just a variation of normal when the babies life could be at stake.

          • MelJor

            She has asked for a referral to a high risk OB. Apparently one baby was “puffy” looking on ultrasound and had a heart rate of only 81bpm. The other baby measured the correct size for gestational age and had a normal heart beat. She is only 12w, so I worry there is nothing that can be done for the failing baby, but the idea she may lose both due to poor care worries me.

          • rational thinker

            Here in the US I am pretty sure if it is a twin pregnancy you have to go to the high risk OB. Even if its a single baby and you are over 35 years old you go to high risk OB I think that is how it works over here.
            I dont know what the rules are in Canada. The fact that she had to ask for the referral is terrifying. It sounds like she needed a more qualified doctor a month ago.

            If they were not sharing a placenta I would think one had a good chance of survival but since they share a placenta the baby who is not doing well will take the other baby with it if things go south.
            Sounds like she needs better care right away. If she got the referral for the high risk Ob then hopefully she will get the care she needs soon before its too late.

          • MelJor

            I think the ultrasound this week was her first, so that was when she found out it was twins. I had a viability and dating ultrasound when I was pregnant just before week 11, which it sounds like this was for her. Such an awful thing to find out and then not have any good answers. I also am hoping she sees a specialist this week and they can make a game plan

  • nata

    to steer the pot a little, I have frequently encountered on facebook claims that stillbirth actually drops after 42 weeks: https://www.aims.org.uk/journal/item/induction-at-term It would be interesting to see what smart lot here has to say on this article

    • MaineJen

      “However, these reviews do acknowledge that the risk of stillbirth appears to be very low in longer pregnancies and the latest one suggests it would be necessary to induce 426 women around 41 to 42 weeks to avoid one stillbirth.”

      What, and this wouldn’t be “worth it?” “Only” one baby out of 426 will die, so why bother about it, really?

      Also…and I’m just spitballing here, but the “better” stillbirth stats post 42 weeks could be due to the fact that a) Not many women have their pregnancies go that long, and b) If they do, and they are getting any form of competent care, they are going to be monitored closely and that baby is going to be delivered at the smallest sign of trouble.

  • guest

    I think the push to let women go past due dates in a lot of health systems is a direct response to a change in policy on c-sections. My local hospital system recently instituted a “no elective c-sections” policy, and also reduced the number of conditions they would allow a c-section for. They are allowed for emergencies, only. If you want a section done, or induction on a certain date, you have to travel and find a private clinic.

    Otherwise, you have to wait to be induced at the last possible minute, and when the induction goes poorly, the hospital can say that a necessary c-section was unplanned/urgent rather than scheduled. Sad, really, to force women they know will likely labor unsuccessfully to suffer just to prove that vaginal birth was attempted.

    • CanDoc

      I’m not entirely sure it’s about some nefarious policy, but more about an attempt to limit the use of desperately strained resources, doling them out carefully. Inductions take a *lot* more resources (monitoring, nursing hours) than spontaneous labour. Cesarean sections take more post-partum resources. Resources that many hospitals don’t have and can’t get approval for. For example, in spite of the fact that our induction rate has gone from 21% to 42% in 10 years (all medically indicated as far as my academic OB group is concerned), and our cesarean rate has crept from 19% to 26% (also indicated – including maternal request), our nursing staffing levels remain the same now as they were 20 years ago.
      The more important issue is pressing for women’s health to be adequately funded. Which is a huge challenge when you’re mostly lobbying male middle aged bureaucrats for money they’d rather spend on middle aged men’s health issues (heart attacks, cancer and prostate care).

      • mabelcruet

        How does continued monitoring post dates compare with induction in terms of staffing and resources? Where I am, every woman who gets to term+7 is seen in clinic every other day and scanned. If they get to term+10, they are seen every day. Does this use fewer or more resources than admitting them for routine induction? I thought the data was that induction at 39 weeks was not associated with an increased risk of section?

        • CanDoc

          Induction at 39 weeks lowers the risk of CS by 3-4% (ARRIVE trial).
          It’s that while you’re doing all this post dates monitoring, a lot of women will actually go into labour, with its lower overall resource requirement.

  • AnnaPDE

    Here is the PhD thesis in which results were published: https://gupea.ub.gu.se/handle/2077/60289
    The rationale behind why the study was needed is scary: I read it as “we weren’t sure when exactly things start going south between 41 and 42 weeks, and we also want to find out how women feel about being pregnant for very long”. In a typical midwifery-talk manner, with mantra-like repetition of how midwife care is empowering, no less.
    Turns out women weren’t happy with waiting around, worried about how birth would go, and felt under-informed by their midwife. It’s also a bit telling how the author tries to dismiss mothers being concerned as “not trusting their bodies” and blame them for it, but has to admit that it’s relevant in light of the outcomes.
    I didn’t have the impression there was proper monitoring with ultrasound for the expectant management group: The thesis mentions that one possible thing to do might be to offer one extra ultrasound at 41w for everyone – currently it’s only done in Stockholm, and all the deaths occurred outside Stockholm.

    • CanDoc

      Ooh, thanks for the link. Wow, fascinating. Thanks for pulling out the bit about surveillance… in the post-41 week group, surveillance consisted of : “In the expectant management group, local guidelines for check-ups were used, and induction of labour was done at 42 gestational weeks plus 0-1 days if labour not had started spontaneously.” WTH are “local guidelines”, that’s sloppy research.
      And as you pointed out, get this: IN Stockholm, women had their ultrasound *BEFORE* being randomized, so anyone with an abnormal ultrasound was excluded from the study and delivered promptly (appropriate care). And then, guess what? NONE OF THEM HAD A STILLBIRTH. Including the women who went to 42+1. So is it safe to let women to to 42 weeks with surveillance? Well, maybe. And this is exactly what the prior research said.
      BUT outside of Stockholm, NO routine ultrasounds, and *5* (maybe 6, debatably), stillbirths.
      So here’s the worst kicker of all of this: After all this effort, this study has in fact contributed LITTLE to the literature. Because nobody should be letting women go past 41 weeks WITHOUT close ultrasound surveillance.

    • Anna

      I really think midwives are out of touch with what women actually want. They ASSUME all women want a vaginal birth with minimal intervention as top priority and are willing to take significant risk to get it.

      • mabelcruet

        Absolutely. I get the impression that the midwives think they know what the women want, and that what the women want is exactly what the midwives want, which isn’t the case at all. I think most mums are sensible and risk averse, and will accept intervention far more readily than midwives do.

    • Amazed

      The first keyword is EXPERIENCES.

      WTF?

      The first keyword is EXPERIENCES and the second one is HERMENEUTIC.

      Now, I’m not a native speaker but I thought hermeneutic had the same meaning in English and my own language. It’s first meaning is understanding, interpretating of a text. What the hell did they explore? How women and midwives INTERPRETED a too long pregnancy? How does one INTERPRETE a dead baby, THEIR dead baby?

      And then, you have LIFEWORD and MIDWIFERY before you see the words PERINATAL MORTALITY.

      It might be a coincidence but anyway, I find it telling.

      Than you for providing the link!

      • AnnaPDE

        IKR. Babies may die if they’re left inside for too long but we want to know how the women feeeeeeeeel, not boring clinical binaries such as dead/alive.
        It is particularly ironic how with all the chanting about midwifery being empowering, individualised and whatnot, the majority feeling in the week going too long turned out to be one of not being properly taken care of, receiving insufficient information from the midwife, and growing more and more doubtful. Oops.

        • Amazed

          I suspect that all they’re going to take from this study is that they should learn how to reassure women better. Not, you know, make them and their babies safer.

      • Lurker

        Admittedly, the keywords are listed in alphabetical order, so I’m not sure that their order represents anything other than that.

        • Amazed

          I hadn’t noticed this. Thank you.

          However, the very fact that they use “midwifery”, “hermeneutic”, “phenomenology” and “lifeworld” and spectacularly fail to mention safety is indicative to what they value. Why mention midwifery at all? Why bring attention to one particular type of provider to the extent of making a keyword about them?

  • CanDoc

    So, I need to walk back on my prior comments. I misunderstood that women were going o 43 weeks’ gestation in the non-intervention group. This wasn’t the case. Women were induced either at 41-41+1, or at 42-42+1. With twice-weekly surveillance, the largest study on this (POST TERM PREGNANCY TRIAL, NEJM, 1992), showed NO increase in stillbirth or perinatal morbidity, but an increase in cesarean section after 41+3. This informs the current Canadian guideline that says options are induction at 41+0, OR twice-weekly surveillance (fetal tracing and ultrasound) followed by induction at 42 weeks. Women should be informed about the options and be able to decide (in my practice I have someone decline induction at 41 weeks maybe once per year). It is unclear to me from the Swedish study protocol whether the women who weren’t induced at 41 weeks in fact had surveillance to ensure the safety of continuing pregnancy for their babies. If they didn’t, the study is ethically highly suspect. If they DID undergo surveillance, then in fact all women were receiving the standard of care used both in Canada and the UK, and these results are a tragic but helpful addition to the literature. (https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0836-9)

  • CanDoc

    This study is horrifying. I can’t believe an ethics board ever approved it given the huge body of literature on this topic. There WAS a trial that already looked at this… THE POST TERM PREGNANCY TRIAL. A LARGE RANDOMIZED CONTROLLED TRIAL that was published in.. wait for it.. *1992*. In the New England Journal of Medicine. I am sure we are not the only ones who will have this reaction and these researchers will, I’m sure, face professional and academic criticism.

  • E.C.

    I am eternally grateful for my elective c-section at 39 weeks.

    • MelJor

      Same!

  • Cat

    One of my biggest issues with hypnobirthing is that, anecdotally, everyone I know who attended hypnobirthing classes was encouraged to “do their own research” on inductions (which, of course, didn’t mean “go off and check what the studies actually say”, but rather, “the doctor is trying to ruin your birth experience, it’s empowering to push back on inducing for dates”). One of my best friends got into hypnobirthing with her second pregnancy and was dead set on refusing an induction if she went 2 weeks overdue as she did with her first child. I was very sympathetic because she had a traumatic labour with her first child that left her very anxious, and here were people telling her “what you did wrong was accept the induction, here’s an easy fix this time if you just wait for the baby to decide to turn up”. But I was so relieved when second baby turned up promptly thus dodging the induction issue.

  • Amazed

    What the hell did I just read? Someone please tell me that I’ve had one cup of coffee too much and I’m now seeing things. I can’t believe they even thought of such a study. I can’t believe they were vetted to do it.

    What comes next, conducting a study to find out if old village midwives knew what they were saying when they claimed that the sun should never set over a labouring woman twice?

  • Anna

    But but but! Lets see how NCB spins this one. Dr Reed has just released her book on induction so we can expect to see similar outcomes in her fangirls. Actually I already know. Some Aussie midwives did a study on ultra low risk hand picked candidates in their continuity of care programs and found less stillbirths – so they are now saying midwifery care reduces stillbirth. That’ll be the answer 500%.

    • ozlsn

      If that’s the one being reported in today’s papers I’m laughing a bit. One paper included the sentence:

      “The study did not determine how many home-birthing women needed to be transferred to hospital, but a 2014 NSW study – co-authored by Professor Homer – found just under one-fifth (18.6 per cent) of home-birthing women were transferred to a labour ward or operating theatre.”

      If that’s still in the low risk planned homebirth population then that would put me right off – I’d rather stay in one place the entire time.

      • Anna

        The one in the papers today only measures interventions I think. They refer to the Homer study which was UBER low risk women and holes in the data around transfers and possible fetal/neonatal deaths being recorded as hospital when the planned place of birth was home. I’ve already seen a comment in a derpy group of someone saying “and they need to tell women that its safe to have a homebirth even after an emergency c-sec”. Shows what an article in the paper with a headline that doesn’t really reflect the study at all can do. I think the study I mentioned might not even be a study. I went looking for it but couldn’t find it. I think its a hodge podge of evidence made into infographics – although saying that there was media around it earlier this year because I remember well the stillbirth community wasn’t impressed with the suggestion midwives could somehow magically prevent stillbirth and pre-term birth. The research just shows that when you have continuity of carer they’re more like to pick something up and refer you on. Would be same outcome with COC care with an OB – but thats not available in the public system.

        • Ozlsn

          I think the Royal Women’s Hospital in Melbourne is now offering team based care where you see the same team right through. Not sure about the other hospitals here, and unsure of how the team is structured. I did see some of the early information, but I think things have changed and developed since then. I’m still getting over having a midwife tell me that women loved being discharged at 24hr post medically uneventful delivery because “everyone just wants to be at home”. Yeah, not what I’m hearing anecdotally.

          • AnnaPDE

            Yeah, this bit with getting to sit/lie around for a few days and people whose job it is taking care of you around the clock, is a lot more popular than they pretend it is. At home is nice but few people manage to actually rest when there’s clearly stuff to be done, and their partner is exhausted too.

  • alongpursuit

    I was induced with both of my pregnancies (first because my water broke and I didn’t go into labour and second because I was 39 weeks along and had high blood pressure). I have had very insufficient breastmilk both times. Every lactation consultant I’ve met with has said that being induced could be the cause of the insufficiency because if I had “naturally” gone into labour my body would have known how to produce enough breastmilk. Yeah.

    So, in my vulnerable state as a new mom I felt awful about being induced and regretted agreeing to it. What if that was the reason why I could not produce breastmilk? I could have been a real natural mama if only I had waited. Now I see how this thinking is nonsense and that nature doesn’t know better than science. I’m glad I wasn’t in the care of those Swedish midwives — I might have waited too long and ended up with horrible consequences.

    • MovingOn

      It’s complete nonsense, too. I went against all of the “traditional” breastfeeding “wisdom” including being induced and agreeing to a non-emergent but still necessary c-section. Maybe it was because of the c-section, or because I was a first-time mother, or both, but my milk took 5 days to come in, so I had to use formula.

      I felt horrible about that breastfeeding failure because I already felt horrible about the c-section (which ended up being very traumatic) and already felt horrible about the induction. It didn’t help that I had pushy family members and in-laws insisting that my c-section was “unnecessary” and I’d brought all of that suffering onto myself (they didn’t know about the trauma). I also had a shitty doula (now ex) friend who blamed me for everything because I “induced too early” at 40 weeks. But what if I’d gone on past 40 weeks? My induction ended in a “failure to progress” after 47 hours. My son was stuck where he was and not coming out without surgical removal. How long would I have had to wait for labor to start on its own? How long would spontaneous labor have lasted before one of these midwives intervened? How long would I have had to wait for a c-section- until there was a “true emergency” which would have been even more traumatic for me and possibly too late for my son?

      I’m also glad I was in the care of competent American CNMs and the on-call OB. I got the care I needed and I’ve finally made peace with what happened during my induction and c-section– no thanks to the NCB crowd.

      • Montserrat Blanco

        Actually inducing earlier decreases the risk of a C-section, probable because babies are smaller. One risk factor for a C-section is maternal age. I do understand having babies late in life (I had my son at 37), but it is not the ideal age for giving birth to your first baby. Most white Western women will have babies late in life and believe me I get it, but then it is not the “cascade of interventions” and “doctors going to play golf”, sometimes it is just your increased risk of some things happening because of your age. And of course there are lots of 40-somethings having natural deliveries out there and I am really happy for them, but of you look at the numbers, the % is not really high.

        I am really glad you have made peace with your sons birth. Thus website helped me a lot. I wanted a natural vaginal delivery and through no fault of my own ended up with a C-section. I had read this website for ages before that happened and it really helped me to process things.

        Best wishes to you and your family.

        • MovingOn

          I was 24 when my son was born, so I also had youth on my side. Turns out, birth is a crapshoot no matter how old you are, but even being a lay person it’s quite clear to me that someone over 40 would be more likely to have problems. As it is, I really wish my midwife would have induced me sooner, but ultimately, having a c-section isn’t the end of the world, I can safely have another child thanks to modern medicine, and my son is now 3 years old, healthy, and developmentally normal.

    • Bea

      I went into labor spontaneously with both of my babies and I never produced more than drops of milk. The lactation consultant told me I wasn’t relaxed enough. So yeah – clearly it’s not whether you were induced or not.

    • Mel

      On the basis of the LC’s logic, every mom with a baby in the NICU for premature labor that couldn’t be stopped should be fine at producing copious amounts of milk.

      Hint: That’s not what happens.

      Making enough breast milk to breastfeed exclusively is a crap-shoot. Some women just don’t have enough milk cells; don’t have milk cells that produce very well; don’t produce nutrient-dense milk; or can’t let the milk out of the breast.

      And bluntly: the LCs are criminally stupid if they don’t recognize that ruptured membranes increase the risk of a uterine infection massively and that high blood pressure brings real risks to mom and baby.

      You might not be a completely natural mama – but you are a mama to two kiddos. That’s worth it.

  • rational thinker

    I was wondering why this study was even allowed. Then I saw the part about most of them being midwives. That explains it.
    We had plenty of data already that bad things happen after 40+ weeks. They needed 6 dead babies to tell them something we already knew. This is just a fucking outrage. Somebody needs to go to jail for this. I am sure mothers were not told about the serious risk of death to their wanted baby. Otherwise who would willingly take part in such a blood bath.

    I wonder if the loss mothers will even be able to sue now, because they probably had to sign something saying they had informed consent which I doubt they did.

    • Ozlsn

      I am curious as to what, if any, additional care they were offered in going post-dates. Because if they were allowed to merrily proceed without any then I would think that would be a reason to sue on.
      Well OK I think the obvious lack of all data being given to the women enrolled would be too, given I doubt the consent was fully informed of all the risks.
      One of my sisters went post-dates but the ob wanted her to come in for daily monitoring and would have induced on a set date if she hadn’t gone into labour by then. My sister still feels that her c-section (baby’s heart rate was dropping with each contraction) was unnecessary. We’ve agreed to disagree on that one.

      • CanDoc

        Agree. If they didn’t have surveillance, then they weren’t receiving the standard of care, which would be completely unacceptable and subject them to liability. If they *did* have surveillance, the increased stillbirth risk *in spite of* surveillance is terrifying and will be very important data that will inform counselling of women about post dates management.

    • CanDoc

      I reviewed the actual study protocol, and these women received what is currently the standard of care in many developed countries: Induce at 41 weeks, or for those who prefer to wait, watch baby closely (heart rate tracing and fluid checks) and wait until 42 weeks at the latest. I can’t tell what they had for fetal surveillance. This is a tragic but useful addition to the literature, given that the largest prior study (Post Term Pregnancy Trial, NEJM, 1992) showed a small increase in cesarean section but no increase in stillibirths after 41+3 with close surveillance when left as late as 42 weeks.

  • Mel

    How on Earth did that study make it past a review board? My area of research is very low stakes because I look at educational methods and their outcomes.

    I had to go back and forth a few times over how best to mitigate the potential harm of “Participant might feel bad at lack of personal growth over the semester” if they didn’t learn as well in a project-based learning class as in a traditional lecture class.

    I grumbled about that quite a bit – but I wish whoever read “Well, we’re just gonna not tell women that their chances of a dead baby increases by 75% if they are in the experimental group” had reacted far more aggressively to the proposal.

    • CanDoc

      Contrary to Dr. Tuteur’s assertion, when the study protocol is reviewed, women in both group appeared to be receiving standard of care (so long as the expectant ones had fetal surveillance). They were induced at 41+0 to 41+1, or waited until 42+0-42+1. Most current practice guidelines are derived from the Post Term Trial (NEJM 1992) that showed no increase stillbirth but small increase in CS after 41+3 in the women who were induced at 42 weeks with had twice-weekly surveillance. As a result, many countries (including Canada) have guidelines recommending at 41 weeks or, for those who prefer to wait, twice-weekly surveillance with induction at 42 weeks… exactly what this study set out to test. https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0836-9

      • Mel

        From the original press release regarding the research:

        There is some scientific support that induction of labour at 41+0-42+0 GW as compared with expectant management and induction at ≥42+0 GW will reduce perinatal mortality and morbidity without an increase in caesarean section rates and negative delivery experiences – but these data are based on partly outdated studies executed several decades ago

        Unless there has been a major change in our ability to detect and prevent perinatal mortality and morbidity since the time of those studies or a major design flaw in those studies, the researchers were playing with fire since the studies indicated increased risk of fetal death or disability along with higher risks of C/S and maternal dissatisfaction with delivery at greater than 42+0.

        From: https://www.sfog.se/media/310978/swepis_sfog__ubw_160830__2_.pdf

        • CanDoc

          You’ve quoted a simple introductory summary statement from the research presentation, rather than actual research. There WAS one prior randomized controlled trial addressing this exact question, over 3000 women, published in 1992 (Post Term Pregnancy Trial, Hannah et all, NEJM)… which showed NO increase in perinatal morbidity/mortality (1700 women induced at 41 weeks, 1700 women had twice-weekly ultrasounds and fetal tracings and were induced at 42 weeks). The “scientific support” cited by the SWEPIS people is more observation data (not from trials) of increased PNMorbidity/PNMortality with increasing gestation, including from before there was any post-dates monitoring. So this was an important trial: with surveillance is it safe to wait it out? Because the prior trial said yes, but only had ~3400 women.

          • CanDoc

            Sorry, the expectant group was induced at 42-44 weeks in the Post Term Pregnancy Trial, not all at 42 weeks. Although most laboured on their own before induction date.

  • mabelcruet

    My two biggest groups of stillbirths are babies in the late third trimester (at about 36-37 weeks gestation), and post-dates babies term+12 and over. In the first group, the cause is usually ‘placental insufficiency’ with sub-optimal fetal growth with no clinical recognition of poor growth, slowing down growth or frank IUGR and the failing placenta simply runs out of steam. This is most commonly in pregnancies that were considered low risk and no one picked up on poor growth (I think about 70%+ of stillbirths haven’t reached their full growth potential).

    The other group, the post-dates group, also tend to be quite stereotypical. Its more common in older first time mothers, and they are also more likely to have IUGR or sub-optimal growth.

    We’ve known this for years, its nothing new. Way back 30 years ago when I was a trainee in perinatal pathology, I started in a department with a very elderly professor. He had three daughters, all of whom were in their 30s at the time, and he told me that he’d made damn sure that none of them went post-dates-he said he’d done too many autopsies on stillbirths from first time mothers in their 30s and 40s who had been allowed to go overdue, and he wasn’t prepared for it to happen to any daughter of his. 30 years later, I feel the same way-its frightening and depressing just how often I hear the same history, over and over again.

    As far as I know, every study looking at the risk of stillbirth shows it goes up once you pass 41 weeks-there isn’t a single paper that claims there is no risk, or claiming that going way past dates is perfectly safe. If the same finding is seen over and over again, why on earth attempt such an unethical experiment? How on earth did they spin it to the mothers, given that there quantifiable risks that we already know about? I’d like to know exactly what they told women to get them to consent to this. It’ll be interesting seeing how the Royal College of Midwives try and address this, given their determination to push forward with ‘normal’ (sorry, ‘physiological’) birth.

  • The Bofa on the Sofa

    Not only would it have been unethical to proceed, it was unethical to undertake the study in the first place. The death of babies was not merely preventable; it was inevitable.

    That was my initial response when I read that statement as well.

    As you posted, we know the stillbirth rate per gestational age. You don’t need a study to investigate that.

    Going in, the researchers knew (at least they should have known) that babies were going to die.

    And for what? What is the friggin benefit of going longer? There was even a comment in the article pointing out that earlier induction reduces the number of c-sections, even! (And that was something we knew before this study)

    So more dead babies, more c-sections…now, what’s the upside?

    Nothing good happens after 40 weeks.

    • mabelcruet

      I had an obstetric colleague (high risk feto-maternal medicine) who looked after a lot of older first time mothers (which in the UK would generally go for shared care between consultant and midwife, or consultant led care because of perceived risk due to age).

      He used the analogy of exercise-imagine you’re a woman over 40, say, and its your first pregnancy. Its the first time your uterine and systemic arteries have been put under the strain of maintaining a hyperdynamic high-flow circulation. You might have kept yourself healthy, but those arteries are 40 years old. The end of pregnancy and going through labour is like running a marathon in the strain it puts on your system, but unlike a marathon you can’t train for it. You can’t do any exercise which is going to improve your uterine vasoconstriction-maternal cardiovascular adaptations can only go so far, and when you’ve got 40 year arteries, that can be a problem. The longer you put the system under strain, the more likely something will fail, so why would you want to keep the pregnancy going for 2-3 weeks longer than it needs? That’s 2-3 weeks where the baby is at increasing risk day by day with a risk that can be completely avoided by early induction. OK, so your pregnancy and labour isn’t going to be ‘physiological’, but surely taking a baby home is the goal here?

    • CanDoc

      Except that the last study of this (Mary Hannah’s Post Term Trial in 1992) didn’t show any increase in stillbirth or other adverse outcomes except a small increase in cesarean section, so long as women had surveillance (twice weekly biophysical profile). So most first-world clinical practice guidelines recommend induction at 41 or twice weekly surveillance and deliver by 42. The observed increase in stillbirth is observational from historic data, not clinical trials. This was a tragic but important addition to the literature. Would be very concerning if the expectant group didn’t have surveillance (unclear from the study protocol), but with surveillance, this increase in stillbirth would be surprising in light of prior research about post dates pregnancy.

      • The Bofa on the Sofa

        this increase in stillbirth would be surprising in light of prior research about post dates pregnancy.

        I turn that around. The result of the “prior research” is surprising considering what we know about gestational age and stillbirth.

        • CanDoc

          Logical assertion but incorrect because of the details: the prior RCT (Post Term Pregnancy Trial) did biophysical profiles twice weekly on the women, inducing promptly if abnormal. Risk of stillbirth within 7 days after a normal biophysical profile is <1/1000 from the literature. The Post Term Pregnancy Trial set a new standard of care to a) offer induction at 41 to 41+3 instead of 42+ weeks, and b) perform fetal surveillance beyond 41 weeks. (The reason for 41+3 is because that's the gestation beyond which risk of cesarean section was seen to increase in the PTPT.)
          The prior observation data about increasing risk of stillbirth with advancing gestation was from the era of NO preventative fetal surveillance. Additionally, at that time there would have been no induction of labour at term for many high-risk conditions with increased risk of stillbirth for which we deliver at 37-39 weeks now. So, the data about perinatal mortality with advancing gestation in fact was taken from a population slightly different from our current population of 41-weekers, who, frankly, to make it to 41 weeks, have to be *really* *really* healthy.
          There are many, many subtleties in this literature that make simple interpretation challenging.

          • CanDoc

            (Incidentally, that last bit makes this new study even more terrifying: Since these Swedish women are presumably also *really* *really* healthy women with such a drastic increased risk of stillbirth beyond 41 weeks with surveillance, does that mean that have an increased risk of stillbirth at 41 weeks compared to 40 weeks? Over a decade ago I predicted that by the end of my career we would be offering all women elective induction of labour at term. With the ARRIVE trial, and undoubtedly future trials to follow, I suspect that the future will be arriving much sooner than even I predicted.)

          • fiftyfifty1

            True. Interpreting degree of risk past 40 or 41 weeks requires nuance. But still: what GOOD happen past 40 or 41 weeks? (besides $$$$ savings of course)

          • CanDoc

            Agree. Age-old Obstetric mantra: “Nothing good happens after 40 weeks.” I remember the old guys saying this when I was new. Now I’m the old guy (gal) saying it to the young whipper-snappers coming out today. 🙂