Tag Archives: RCT

Moxibustion: A Smoke Screen?

Screen Shot 2014-06-13 at 01.38.38Professionals: Concerned about women waving giant sticks of burning wacky weed around their wee toes in a desperate attempt to turn their breech babies?! Take action NOW! Ensure that these women can access support for a vaginal breech birth with an experienced, trusted professional, and you will no longer have to busy yourself trying to root out such madness!

Screen Shot 2014-06-13 at 06.51.12Last week the results of a trial (Coulon et al 2014) were released which appeared to show moxibustion with acupuncture ineffective in causing more babies to turn head-down. The trial had its good points. A reasonable number of women randomised (328) at the appropriate point in pregnancy (33+4 – 35+4) to use moxibustion for maximum effectiveness. This in itself was impressive, as most centres do not bother about breech presentation until 36 weeks, making recruitment for studies during this time period difficult. The team looked at the percentage of babies who remained breech at 37+2, the point when ECV (a procedure to manually try to turn the baby in the uterus to a head-down position) would be offered, and found that 72% who had the treatment were still breech, compared with 63.4% who had the placebo. They reported this was not statistically different, but superficially it looks like the treatment had the opposite of the desired effect.

Screen Shot 2014-06-13 at 01.38.58On the other hand, they appear to have used actual needles, heated with moxibustion, rather than the method most commonly used in UK-based moxibustion practices, which involves using the heated sticks only. Also, the intervention and placebo were applied for only six sessions. Generally, women using moxibustion in the UK are usually taught to home-administer (usually with the help of her partner) and then instructed to follow a ten-day course, applying moxibustion twice a day, and continuing whether the baby turns or not. The ten-day, moxibustion-only practice follows a less treat-to-cure, and more treat-to-nourish philosophy, the idea being that the moxibustion nourishes the energy of the womb and promotes optimal positioning. (No swearing until I’ve finished the article, please!)

Screen Shot 2014-06-13 at 01.39.14I’m a fan of observing responses to research on Twitter. (See this previous discussion on hypnosis for childbirth.) And Twitter did not disappoint. The Green Journal announced the Coulon study, and obstetricians celebrated their vindication for having dismissed the practice years ago. There’s nothing like the joy of scientific confirmation of one’s deeply held beliefs. It was as if somebody walked into a room full of midwives and said, “Hey, guess what? Continuity of carer improves outcomes for everybody!” (By the way, it does.)

Screen Shot 2014-06-13 at 02.12.23But then a woman who had actually experienced a breech pregnancy pointed out the obvious: What are the alternatives? Generally, women are highly motivated to give birth vaginally (Raynes-Greenow et al 2004Guittier et al 2011). They instinctively feel what the research tells us – that  a normal birth, wherever possible, is beneficial for both babies and women. There are many hospitals throughout the Western world, including some in the UK, where women cannot even access an ECV, let alone a vaginal breech birth. I’ve had phone conversations where I’ve asked to speak with the person who performs ECVs and been told, “We don’t do that here for liability reasons.” Folks, it’s 2014.

Screen Shot 2014-06-13 at 01.38.22With evidence-based counselling based on the outcomes of the Term Breech Trial, Kok et al 2008 found at least 35% of women preferred to plan a vaginal breech birth. Evidence-based counselling includes the lack of evidence of any difference between two-year outcomes whether an elective caesarean section or a vaginal breech birth is planned (Whyte et al 2004). We can reasonably conclude that if approximately 1/3 of women are not planning a vaginal breech birth in a given setting, then they are probably being directively counselled towards a caesarean section. This would include feeling forced to choose a caesarean section because no plan will be put in place to ensure attendance at a vaginal breech birth by an experienced and supportive professional.

Screen Shot 2014-06-13 at 01.41.57Women resort to practices such as moxibustion and handstands in the swimming pool because they are constantly given the message that breech presentation is ‘wrong’ and should be corrected, with very few alternatives. Whereas the evidence indicates that turning babies, even with ECV, does not improve outcomes for those babies, though it certainly improves the chances of a vaginal birth in settings with minimal support for vaginal breech birth (Hofmeyr and Kulier, 2012 – Cochrane Review). I am increasingly uncomfortable with the current situation, where women do things they do not actually want to do because they cannot access a vaginal breech birth at all, or will not be supported to choose that option until they have done everything else (especially ECV).

Screen Shot 2014-06-13 at 01.40.36Personally, I have no strong opinion on the use of moxibustion itself, as I generally prefer to leave the use of complementary therapies up to what works for individual women, as long as they do not pose a threat to her or her baby. I have taken training to be able to offer women advice, and I have supported women through the use of moxibustion. (We usually spend the ‘treatment’ time talking through the issues around breech birth.) When I speak publicly about breech management, someone usually asks me why I have not included moxibustion. And I tend to dodge the question, not so much because I am convinced of its efficacy or not, but because I believe it is professionals’ attitudes towards breech presentation and not the breech itself that needs to be ‘corrected.’

Screen Shot 2014-06-13 at 06.19.23Let me propose this radical solution: Why don’t we channel some of that indignation over moxibustion practices into ensuring that breech services improve to a point where women will not need to look elsewhere? Let’s ensure every woman has access to a well-supported vaginal breech birth, an ECV attempted by a highly experienced practitioner, and/or a woman-centred caesarean section as late in her pregnancy as she wishes to plan it, including in early labour. Let’s ensure that women have sympathetic, experienced counselling and continuity from a midwife while they navigate these choices, and the attendance of a highly experienced consultant, ready to step up and be that expert in complications of childbirth, backing up the team at birth.

No Re-tweet, sadly ;-)

No Re-tweet, sadly 😉

While we must always make room for those who choose a different path, I suspect that if we got a bit more comfortable with breech in general, the debate over whether moxibustion has a place in the mainstream or not would fade into the distance. Stop blaming pregnant women for their misled attempts to avoid a caesarean section, and the sympathetic midwives who are desperate to help them, and sort out primary breech services.

Shawn

 

 

 

 

 

Choice 1 Choice 2 Choice 3

 

 

 

[Note: I can only access the abstract to Coulon et al at the moment, as it has been posted ahead-of-print. I’ll update the post when it’s published, if there’s anything more to say.]

 

Why midwives are sceptical

This blog is Part 2 in a discussion about on-going RCTs looking at induction of labour (IOL) at various gestations: Why midwives are sceptical about research on medical interventions

In theory, research like this is done in order to support clinical decision-making and to enable informed consent for proposed interventions. If midwives seem dubious about the merits of research concerning medicalised birth, it is because our experience indicates that truly informed consent is a rare beast. Once an RCT has decided that a certain course of action results in less risk for baby, any woman who wants to take a different course will most likely have a fight on her hands, with most health professionals, family, friends, even her partner.

Because it is socially unacceptable to say – It is okay for a woman to choose an option which appears more risky for her baby. Women are not just baby carriers. They live complex physical and emotional lives in which other factors are important too. – midwives end up in the awkward position of trying to argue with The Truth of big science.

Soon, someone will get funding to do an RCT looking at whether the outcomes for babies are better for low-risk primips who undergo elective CS at 39 weeks, or normal labour. And my guess is CS will come out on top for the Big Ones – reduced morbidity and mortality. And then what? Will all primips be offered a CS at 39 weeks? And those who refuse?

I’d like to think we could use the information from these trials to truly offer women an induction of labour, acknowledging that it will not be right for everyone, but as a midwife I see every day what happens to women who decline the Recommended Treatment. Take for example this recent Tweet:

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Is it really okay for an ‘anaesthesiologist’ and president of MSF-USA (Doctors Without Borders) to publicly discuss this tragic outcome, in a way which implies that a woman who declines a recommended CS is selfish, cold, heartless .. & uninformed (despite having definite, and accurate, reasons for refusing). Putting her own experience ahead of her baby’s life, as if losing a baby is ever a good experience, even for the most ambivalent. Are women who decline medical advice no longer entitled to respect and confidentiality? This so-called professional then used the MSF-USA twitter account to re-tweet this damning judgement to 361,500 followers. Midwives in the UK are struck off for less.

We need more research on how to increase the quality rather than the quantity of birth, and life in general; and the quality of women’s experiences will certainly improve with more compassion and less guilt-tripping. Childbirth is not a trip to Walmart.

I want women to have the choice of an early induction, or a CS, if research indicates it may benefit their baby. If they feel it is the best choice for them, so do I. But I want women who don’t want this to have their choices acknowledged as equally valid and equally supported. And I don’t have a lot of faith that will happen.

Finally, because it’s my blog: For me, going into labour was like falling in love. The agonising wait, wondering when it will happen. The brief period of terror when I realised it had. Followed by succumbing. Followed by a lot of hard work and ultimately, blessedly, joy. For me, it was worth waiting for.

Shawn

How the consent process introduces bias into RCTs

Part 1: Why I remain sceptical of RCTs concerning obstetric interventions in normal labour and birth

Another blog post in response to a Twitter debate .. this time concerning various RCTs currently evaluating IOL vs expectant management. We’ve been discussing three trials:

The questions are valid. We know stillbirth is increased, especially in certain populations, the longer a pregnancy continues. In order to make an informed decision, many women will want to know the most likely outcomes and effects of opting in or out of proposed interventions. RCTs are considered the most unbiased way of settling these issues, unsullied by the biases of women or health professionals.

The problem is, these interventions are eventually applied to a population that is, due to being human, inherently biased. Some women feel a strong preference in one direction, some in another; and some want their doctor to decide for them. Women need to consent to be randomised into RCTs, and women who are most averse to the proposed intervention simply decline consent. Therefore the population recruited becomes slightly biased towards a preference for the intervention being investigated.

Is this important? Does it matter? I don’t know. Recent research by Wu et al suggests that women with a strong preference for vaginal birth were more likely to have a vaginal birth. RCTs cannot tell us the effect of women’s preferences on the outcomes they measure. Yet in theory their results are used to offer women an option they will almost certainly have an opinion about.

If I were contributing to the design of these trials, I would want to collect observational data alongside the main trial data. Things like:

  • Why do women consent or decline to participate in the RCT? Are the women who declined to participate due to a strong preference against induction more or less likely to have a normal birth? Are the outcomes for their babies significantly different than those in either arm of the trial?
  • What are the long-term outcomes? Especially in the over-35 population, an increase stillbirth rate may be due to inherent weaknesses in the baby. Significant long-term differences are often not detectable until 2 years of age.
  • And finally .. would they do the again? Would they recommend it to a friend?

These are questions best answered using quantitative techniques, but women may have different questions or priorities, which we will only discover using qualitative investigations.

See Part 2: Why midwives are sceptical.

Shawn

When the science of midwifery undermines the art

Self-hypnosis for pain relief in labour

Obstetrician and canoeist through the thick waters of controversy Jim Thornton drew my attention to this recent trial, published by the BJOG in February (Werner et al 2013, read it here), through his blog (read his post here, always though-provoking). Jim calls the trial ‘lovely,’ but I can’t agree. Rather, I think it illustrates how research, if not appropriately designed, can potentially cause more harm than good.

This study was well-conducted in randomised controlled trial (RCT) terms, so we can depend on the results: Take a group of women who are up for it and randomly allocate them to a short course on either self-hypnosis, relaxation, or standard antenatal care. They then give birth supported by a midwife who is not allowed to know how they prepared to self-manage pain in labour. You will find that no one education intervention results in more or less pain, more or less need for epidurals, nor any noticeable difference in satisfaction with their childbirth experience. I’m not surprised.

I was pleased to see the authors shared many of my concerns in retrospect and can only imagine it was over-confidence in a technique they had observed many women use with great satisfaction that led them to proceed with a trial design which featured some predictable flaws. One of my biggest concerns was that staff were blinded about the woman’s allocation. Effect: most of the time the midwives could not guess correctly which group the woman belonged to. This was a piece of midwifery research, but it effectively disabled midwives from practicing their art, sympathetically enhancing the woman’s coping techniques using knowledge gained about that woman through their relationship.

This debate was bugging me until I picked up the latest issue of The Practising Midwife and read midwifery lecturer Charlotte Kenyon’s very sensible piece on ‘Clinical hypnosis for labour and birth: a consideration.’ She discusses the difficulties with conducting research in this area (I refer you to her article for a fuller account; TPM is digitally lacking, so visit your library), but most importantly she points out, “No recent studies could be found which employed individualised hetero-hypnosis” (Kenyon 2013, p12).

Individualised hetero-hypnosis’ is what you get when you give midwives a set of tools (along with women) and enable them to use them to support women on an individualised basis, according to the woman’s needs and values, enhancing the woman’s own coping skills. Delivering individualised care, sympathetically combining experience- and evidence-based knowledge, is the art of midwifery. In contrast – “Where research is undertaken using formulaic scripts, results may be affected by the use of a one size fits all approach to a therapy which by its nature is individualised” (Kenyon 2013, p12). Yep.

Soo Downe is currently conducting an RCT (registered here) on the use of self-hypnosis with a mixed methods design that appropriately includes other strands of contextualising data collection such as interviews, focus groups, logs and questionnaires. Importantly, the midwives supporting women in labour will not be blinded; therefore, the conduct of the trial itself presents an opportunity to expand the practice of midwives providing individualised care. This sounds like a study which will pragmatically improve our understanding of how women use self-hypnosis and how midwives can enhance women’s own efforts, as well as whether or not there is a quantifiable difference in outcomes which would justify increased investment to integrate such services into the NHS. Can’t wait for the results.

So what harm can come from poorly designed research? Well, I wouldn’t have liked a positive outcome for the Werner trial to lead us down a path of advising all women they will have a better time if they use self-hypnosis (without a greater understanding of who it is most likely to help, how and why). But I also don’t like the idea that on the back of this large RCT some individual women’s use of self-hypnosis will inevitably be dismissed by some professionals as ‘not evidence-based,’ rather than respected and appropriately supported. This could undermine a woman’s confidence and feeling of being supported in her chosen coping strategies. For what? Because we know better?

Declaring my personal biases (because it’s my blog): I have never been drawn to using hypnosis (self-administered or otherwise) while giving birth, despite having four home births. If you told me I would never have to listen to a hypnosis CD throughout a night of someone else’s labour again, I wouldn’t complain; they make me feel like I’ve just had a lobotomy. My personal birth mix included Nina Simone, Herbie Hancock, and Madonna’s ‘Like a Virgin,’ just to lighten the mood while I swore like a trucker. But I trust women. Having listened to many women describe how hypnosis-related techniques and programmes helped them feel more confident and in control, and having watched them give birth, I am siding with those who insist their experience be properly accounted for before we close the book on the hypnosis for childbirth debates.

Reference

Kenyon C (2013) Clinical hypnosis for labour and birth: a consideration. The Practising Midwife. 16(5):10-13.

Update 2015 – You can read Downe et al 2015 by following the link.

BJOG. 2015 Aug;122(9):1226-34. doi: 10.1111/1471-0528.13433. Epub 2015 May 11. Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness. Downe S, Finlayson K, Melvin C, Spiby H, Ali S, Diggle P, Gyte G, Hinder S, Miller V, Slade P, Trepel D, Weeks A, Whorwell P, Williamson M.