Smoking in Pregnancy Challenge Group Webinar – Nicotine in pregnancy

welcome to today's and nicotine in pregnancy I'm hazel Cheeseman I'm director of policy and ash and I'm just going to run through some housekeeping before I introduce our two excellent speakers and if you have any technical problems during the webinar can you use the chat function on the panel on the right-hand side of the screen and let John and Vicki know that you've got some problems and they will try and help you and if you have any questions during the webinar then you we really want to hear from you there's a question tab on that right-hand bar so you can type the questions in and only only officer organizers can see them and we will put those to the speakers at be at the end of the session we're also recording the webinar and it will go online so you'll be able to share it with colleagues and others who were interested so I'm just going to say a few words to introduce the challenge group and the issue of making and pregnancy before handing over and first to professor Linda bald he's going to talk about nicotine in pregnancy and then to Professor Peter Hayek is going to give us some more details specifically around cigarettes and then we're going to be joined in the panel session by Joe Locker from public health England and Louise hand who's a public health and midwife from South T's and to have a wider discussion about nicotine e-cigarettes and their role in pregnancy so we're really keen to hear from you and so that we can have a really good discussion session at the end so definitely get those questions in and to remind me and to remind you where those questions and where that questions have is on the right-hand side of your screen so just a quick introduction to this making a pregnancy challenge group we're a wide coalition of NGOs and professional groups and academics who have come together to to find ways to reduce rates of smoking in pregnancy and we were established in 2012 following a challenge from the DEM public health minister and we've produced a sort of array of policy reports on the other side of this slide here and making recommendations to government locally and nationally about what needs to be improved and change that we can more quickly reduce rates of smoking in pregnancy and but we've also done a lot of work to and support frontline delivery as well and and local networks and attribute information to be supportive of that objective and I'm not going to talk a lot about that now but if you want more information about the resources that we have you can visit the smokes making in pregnancy challenge group web page and we'll circulate these details after the after the webinar and we'd also encourage you if you haven't already to join the smoke free pregnancy information network which will be getting monthly updates on smoking in pregnancy issues so without further ado ah yes it's just a remind remind me to tell you that we have two webinars coming up which you can register for we have one on incentive schemes at the end of this month on the 28th of March and then one at the end of April on looking at health visiting and relapse prevention and which should also be very interesting so I will now hand over to Professor Linda bald who is the Bruce and John Asha professor of Public Health for Edinburgh University Linda's also the co-chair of this making and pregnancy challenge group alongside kleehammer whose chief executive of Sam and then just going to talk to us about the evidence relating to the use of nicotine in pregnancy so I will hand over to Linda at this stage Linda I think you might want to make your and slides a little large on your screen yeah they're not great thanks Linda okay great and delighted to be here and to be able to speak about this important topic so I'm probably only going to take about 15 minutes and I will try and set the scene for what Peter is going to cover later and so what I'm going to talk about is very briefly the importance of reducing smoking and pregnancy which has already begun to speak about then talk about replacement therapy in pregnancy just set the scene for what is nicotine and why it's important to understand this issue in the context of harm reduction all they then say something about Cochrane reviews which talk about pharmacotherapies both in terms of efficacy and safety and then introduced you to the snap trial which gives us valuable evidence from the UK context on both those issues and then talk about some ongoing work we're doing in a new NIH are funded program looking at evidence from non randomized trials no randomized studies pardon me and on nicotine in pregnancy and then finally I'll just say something about ongoing research and I look forward to your questions so as many of you will know we have made tremendous progress in reducing rates of smoking in the population including in pregnant women we were delighted that our most recent national tobacco control plan in England as pregnancy specific target of reaching prevalence of 6% at the time of delivery by 2022 but unfortunately we are not making progress at the rate that we need to and that's why the challenge groups work is still so essential in in collaboration with yourselves and we have just had the latest at our data released which is not on this slide so and the data for quarter 3 for 2018-19 have just been released this week by NHS digital and smoking at the time of delivery was 10.5% and those latest data that's the same as the quarter before quarter 2 and there's no significant change from this time last year where it was about ten point eight percent but that's not a significant drop of course the variations remain very significant ranging from 1.5 percent of smoking at the time of delivery in richland up to and just over 27 percent in Blackpool I'm in relation to the gradient that we're all familiar with you know that women who live in the 10% most deprived communities in England have far higher rates one in five of them continue to smoke at the time of delivery right down to around 2% for the least deprived SR so the about the inequality challenge we've not managed to narrow the gap in recent years and those women living in those communities are real priority for addressing smoking and pregnancy the same for age and we know that many of our partners in the challenge group Tommy's and another baby charities who work with teenage pregnant women and the rates are far higher in those groups and also younger women and the rates of smoking pregnancy decline with maternal age so again this is a priority for support and for action and I think everyone listening to the webinar will be well aware of the risks of smoking and pregnancy we did a new analysis I should say we my colleagues with hazel and others did a new analysis last year looking at updating some of the evidence and trying to communicate in a simple way what some of the risks were on average across studies in relation to low birth weight the very important potential risk of stillbirth with smoking still being the leading preventable causes of stillbirth miscarriage preterm birth and then also health impacts on on the baby in relation to heart defects and also sudden infant death postpartum so we're very well aware of these they apply across the globe we see new evidence from countries in Latin America for example just last year shown very clearly these wrists are consistently found and of course is not just combustible smoking we also see significant risks for pregnant women who use smokeless tobacco products which of course is relevant for our South Asian communities particularly in the UK and in fact we're doing some research on that at the moment so moving on to the the main topic for today nicotine in pregnancy so in the UK we are unusual globally and that we routinely provide nicotine replacement therapy to pregnant women that is not the case around the world and that really hasn't risen since around 2005 when the MHRA changed the licensing rules on nicotine replacement therapy to allow prescription for pregnant women also a whole variety of other priority groups have just listed a couple of them here patients with heart disease and children over the age of 12 we did a survey of stop smoking service a few years old now when we have more services more comprehensively across the country but we found that basically all services who were supporting pregnant women in any numbers were providing an hour to routinely and when we develop the nice guidance on smoking cessation in pregnancy back in 2010 it included a recommendation guidance that NRT could be provided but emphasize that professionals who use their clinical judgment and also discussed the risks and benefits with women you know those guidelines have not been updated since 2010 but there is currently a guy in this group that nice has convened to update a suite of guidance and pregnancy is included in that so I think we'll be seeing that coming out in about 18 months time unfortunately as I'll explain in more detail as a moment there isn't any evidence of effectiveness for NRT for smoking cessation in pregnancy and there's a range of mechanisms than I explained that lack of effectiveness the key one is probably the increased metabolism of nicotine when a woman is pregnant there's a whole variety of biological changes that occur but of course to decrease metabolism is one of them the other big issues that wouldn't don't like using NRT so there's limited adherence to the amount and frequency and that should be used ideally to prevent or to support smoking cessation or prevent relapse which is smoking so just relation to some basics about nicotine no it's really important to emphasize this is something that doesn't just exist within tobacco it's it's common in a whole variety plants which is why when you look at cotinine levels in the population you'll find some of us have most of us have some codename in our systems because we get it from vegetables basically and but also obviously it's included in the tobacco plant nicotine can be produced synthetically but it's very expensive and and widely regarded is not commercially viable and that means that it's important to remember that the nicotine in cigarettes and other nicotine containing products including NRT comes from the tobacco leaf so it has a common source a nicotine is both a sedative and a stimulant stimulant and the body response and a whole variety of ways to nicotine including increasing the heart rate blood pressure there's also potentially beneficial effects of nicotine we see that Parkinson's disease is less common and people who smoke and there is evidence that that mixing we can improve memory and cognition and indeed there have been some trials in different populations to look at the potential benefit beneficial effects of things like NRT nicotine can be addictive but it depends very much on the mode of delivery and NRT of prescribe meds and his way he regarded as not dependents forming so we have guidance on nicotine use in the UK we have our tobacco harm reduction guidance which is also being updated in that suite of nice guidance I mentioned published in 2013 when we met as a group we didn't include pregnancy in this guidance that's important to emphasize but the reason is valuable is because of the systematic reviews underpin it they're also available in the nice website and they reviewed all the evidence on nicotine and the physiological effects outcomes from using NRT and the evidence makes it clear that there are no circumstances under which it's safer to smoke and to use nicotine replacement therapy and the guidance emphasize the importance of nicotine containing products for temporary absence for cutting down smoking ideally as a route to stop for smoking cessation and for longer-term use potentially over many years if that helps people avoid it relapse to smoking so that's all fine and but we haven't really made much progress in relation to what the public think about nicotine I don't have time to show you the evidence that we've included in our recent public health England ports on e-cigarettes which basically show that people are still very confused about this they think that nicotine causes cancer they think the nicotine is harmful and and those perceptions have really not improved in recent years and when you look at studies with pregnant women it's very clear that when women are concerned about nicotine they may know about the resist working generally they do although they may not understand all the risks and but they also think that nicotine is harmful a low separate from tobacco so they're concerned about safety they're also concerned about addictiveness so this this concept of using another nicotine product continuing to crave make a team and therefore that using things like NRT might actually increase increase their risk of relapse to smoking after they have the baby or indeed during the pregnancy and I've just included here I could have provided other references as well we did a large series of systematic reviews for NIH our and published a report a couple of years ago but this is just one article from my current colleagues a few quotes here just illustrating what pregnant women said about nicotine replacement therapy and nicotine and then of course the other finding is although we are better about this in the UK than most other countries including the US and we still be a very variable advice and support to pregnant women regarding nicotine replacement therapy and NRT the advice might be good from stop smoking services that when women talk to their midwives or and obstetricians or other health professionals about this they may well get conflicting messages and knowledge amongst health professionals generally around nicotine remains poor so in relation to nicotine use in pregnancy we have a Cochrane review which I've given you the reference for at the bottom of this slide updated in 2015 looking at pharmacological interventions for smoking cessation in pregnancy in the most recent reviews so the search was done I think in the summer of 2015 they identified nine trials of NRT and one of the program done in the US and in relation to safety there were no differences between the women who stopped smoking and used NRT in relation to miscarriage stillbirth premature birth low birth weights and I heard outcomes for infants that would result in it being admitted to neonatal intensive care and congenital abnormalities neonatal death and other outcomes and there were some non serious side effects observed with the woman who used NRT and these are the things you see in the general population nausea skin irritation from patches really not liking the gum but these data were not sufficient to be cool to look at whether those outcomes were consistent or found across a range of studies so basically just to emphasize the Cochrane review found no difference and that basically means that they couldn't identify and identify any serious risks from women using NRT in pregnancy so that's fine that provides data for a range of countries primarily the US I have to say in relation to the trials is also trial in France but probably for us here in the UK the most relevant and one is a snap trial under by NIH rhj led by Professor Tim Coleman at the University of Nottingham and this was a large trial over a thousand women and had to be smoking at least five cigarettes a day when they were enrolled and ten pregnant pregnancy validated by carbon monoxide they were given behavioral support for up to eight weeks and 16 hour nicotine patches you know women are advised not to wear the patch overnight when they're pregnant and and they're in the control arm were given the same behavioral support with a placebo patch and then they were followed up in relation to the main outcomes at one month and then at delivery and then the babies were followed up until they were two years old which I'll talk about in a moment so the snap findings are similar to the trial in France and trials in the u.s. basically showed that at four weeks it looked like the NRT group we're doing better so that's the first bar on the left-hand side you can see that there was a significant difference in cessation rates for women at one month in the NRT arm compared to the control arm but when you got to the point of delivery that difference was not significant anymore so delivery was the primary outcome for the trial and that suggested that that single product the patch was not effective for smoking cessation and for me this this is a table that is a meta-analysis of pooling the results of the various trials and you can see that there's one by Tim Coleman and colleagues at the top here and that's included and essentially just showing that when you pull the data from the trials together at that time when this meta-analysis was done and it really doesn't show that she has a significant effect on smoking cessation so that's effectiveness and I'm going to talk in a moment about the work that we're doing now to see and if we can look more closely about a different regime for NRC and why that might help women and more than a single product and this was the two-year follow-up from the snapshot and effectively they were following up the babies for two years it was primarily by questionnaire I mean Oakland they were looking for here a survival without impairment so no disability amongst the infants or problems with development and I've just listed here the tools that they use they also looked at respiratory symptoms and whether the women had stopped smoking over the longer term this just shows you the response rate they weren't able to follow up all the women but they had a good response and over the two arms just move on to the results consciousness time this is a really important slide these are the infant outcomes in two years from the snap trial and just remind you they're this survival with no impairment is the primary outcome and you can see that there were significantly more babies in the nicotine replacement therapy RMI either women who used NRT in pregnancy to stop smoking than in the women in the placebo arm there were slightly higher respiratory problems but not significant and they did the analysis and a couple of different ways and found the same results so the implications this was the first trial that looks at infant outcomes up to two years it's really the first one that found a beneficial effect of nicotine replacement therapy on pregnant smokers children and and one of the potential hypotheses is that even though the NRT wasn't it's very successful for smoking cessation they were undoubtedly a lot of women even used it to cut down their smoking if even if they didn't completely quit and that probably had an impact on the outcomes for children so the work that we my colleagues are doing now again at most think it was looking at safety from non randomized trials and there are a whole bunch of these studies and essentially they give us really good information because we can look at different outcomes across a broader range of studies in women in different countries and these are the main outcomes that are looked at in the non randomized studies preterm birth birth weight small-for-gestational-age stillbirth congenital abnormalities and other outcomes so the bottom line here is these findings from non randomized trials are consistent with those from trials and they provide additional detail they primarily look at women who smoke or use NRT or both in pregnancy and overall for the outcomes mentioned in the last slide there are fewer pregnant negative pregnancy related outcomes when energy is used compared to smoking so energy used by smokers is not associated with poor outcomes but smoking alone is so NRT probably has a protective effect even if they women don't completely quit we're looking at better outcomes here for the infant there's one outcome that looks worse a man or two users and that's if you call it I'm no expert on that condition I know it's difficult to assess that causes are different difficult to identify clearly in relation to some of the other outcomes and that we observed for smoking pregnancy however it's not nearly as severe and so it's if it is a risk it's probably one that can be managed so that review of non randomized studies is part of a large program of work we're doing now again funded by NIH are led by Professor Tim Coleman it's program it contains a series at work streams variety of systematic reviews one is on safety but crucially within the program we are now designing a trial of higher dose and artis that's combination therapy basically we know in routine practice and stop smoking services that's what pregnant women are commonly provided there's some observational evidence to suggest the outcomes are better basically when this means women are getting more nicotine and that will probably deal with some of these issues around metabolism that I mentioned and that women can be supported and encouraged to using nothing for long enough it may well really help them stop smoking but we won't know that for sure until the trial produces its results so there should be some value or the evidence there so just to finish you know the issues smoking pregnancy a priority to address in the UK NRT is widely prescribed in pregnancy and we have a high quality UK trial that adds to other evidence to suggest that single product NRC doesn't look very effective for smoking cessation but it is safe and non randomized studies also suggest that using nicotine replacement therapy as far as safer than smoke smoking and so the bottom line is that although we have ongoing research underway and Peecher is also going to talk about another important study the priority is to help women to stop smoking and pregnancy even if they continue to use nicotine in a less harmful form than in tobacco thank you very much Thank You Mindy and chairs dream you finished a minute early and I'm just going to ask you while we hand over the control to Peter for his presentation and just one of the questions that's come through somebody was asking about smoking prevalence among women who are accessing mental health services I'm not aware that there is any data on this but I don't know if you wanted to comment a tool on and these sort of additional risk factors around women with mental health conditions they might be pregnant yes combined whether people are pregnant and then obviously the mental health conditions that are assessed there but as you know that survey still sadly only happens every 10 years or so we don't have good obviously we know that as rates of smoking in the mental health service using population in general are far higher than the general population and of course when there are women of childbearing age in those groups who become pregnant so the combination mental health conditions which of course are associated with a whole range of other risks for themselves and the fact that they're tobacco users will make those high-risk pregnancies so I think in mental health services and and stop smoking we need to be partnering and that's why the mental health not mint health challenges it hazel it's the mental health partner and their mental health ins making partnership Porsha ash what's missing and one of the things hazel and I of course haven't had a conversation about is how we combine the those two groups but I think the question just posed perhaps suggests that's the conversation yeah I think of Thornton so we should have a have a have a conversation about that and the other thing I just wanted to quickly ask you and encourage people to add their questions we have got a few more but we'll take them at the end and you mentioned preparation as well as NRT but not varenicline also known as Tampax and the movie that's because it is not recommended for use in pregnancy that's right so it's not licensed for use in pregnancy in the UK I would say there is some research underway my colleague Sri Lankan in the US has been doing a trial but we're not it we're not currently private in Prince great thanks and oh well encourage you to and put more questions in the question sidebar and we'll pick them up at the end and thank you to those of you who've already put some in so we're now going to hand over to Professor Peter Hayek and Peter is the professor of clinical psychology and the director of health and lifestyle of the health and lifestyle Research Unit at the Watson Institute of preventative medicine at Queen Mary University people are quite a mouthful and so Peters going to be talking about the effectiveness of e-cigarettes and cessation aid and talking about a recent RCT that he's been leading and then go on to talk about a trial around pregnant women so Pizza over to you right can you hear me we can't thank you so I'll be talking about two trials one of them the recently published one and one which is ongoing and concerns pregnancy so this is the first one comparing a cigarettes this nickel replacement treatment within UK stop solving services this is something we are supposed to do I have no links with an e-cigarette manufacturers my research into these things that had been funded by all these Auguste bodies the trial was a collective effort of a develop people very involved in this now we already had two rather old try of looking at the efficacy of e-cigarettes one of them was just comparing a cigarette with and without nicotine which does not actually convey that much useful information the other one has the same thing that also included a touch arm of the trial both trials used very early first generation CGI e-cigarette as well nicotine delivery and they had very limited behavioral support the overall conclusion was that e-cigarettes with nicotine do better than those without nicotine and the Patridge and this early e-cigarettes had about the same efficacy by difficulty was pretty long so this was the first trial to look at modern e-cigarettes and we come we used as a comparator combinational replacement treatment then this is why because that's the most commonly used approach within the UK stop smoking services as you can see here over half of people coming without receiving treatment and among those more than half of those 50 focuses 32 of lis this combination treatments so that was our comparator people were randomized to one or the other and they started to use their product on the target quit date so we didn't have a differential dropout just in case people were keen to use one owner although the other but the inclusion criteria included one which asked people whether they mind whether you use one or the other and if people have strong preference or really didn't want one of them then they are not in the trial so the hope was that people don't really mind which one they're using and indeed the attendance and adherence and all that and drop out that all suggested that indeed that was the case we elicited a committee and from then they signed there is a form saying I promise I won't be using the non allocated product for the first four weeks at least and indeed they stuck with it pretty realizing there were few who who use something they were not supposed to but overall this work or right and then they had weekly face-to-face support sessions as per usual practice within these services I somehow drop drop the slide there showing which service it was it was for services which have which are still functioning as you may know a lot of services are no biting the does but these were still providing face-to-face contact with dedicated full-time advisors and after those four weekly sessions people have followed up at six months and twelve months and those who reported abstinence at 12 months or smoking less than 50% of their cigarettes they did at baseline they've invited to come back for carbonyls are reading to validate their claim of abstinence and to see if the reduction in those who reported reduction in visa reached at least fifty percent so in the NRT arm people had a choice of all these different products and they were encouraged to the combination and typically it would be the type of combination with in the routine service that means patch plus one of the shorter acting product the mouth spray was particularly popular there as 88% opted for the combinations a few people use just the patch most two different products another thing they were allowed to switch so if they started say Oh nicotine chewing gum and didn't like it they were able to switch to inhalator or lozenge or something else and this was this was a busy evening many people did switch sorry is there a ye some know it is there Oh oh goodness me hello do you hear me maybe we can hear you it's fine I think we're just having some interference no you need to meet yourself I think that fear she do you carry on Peter sorry alright so let me continue to talk to myself there's a so a surprising number of people switched to another product and the supplies went on for about three months well for three months after that those always they requested longer supplies some services it provides it the cost to a matrix of this on average is about hundred twenty pounds for the three month supply one product supplying two products doesn't make it twice as effective because the second product is usually used not fully that means not fifteen pieces of chewing gum a day but only a few to top-up but still it would add additional cost if there is a dual product for e-cigarettes we used this one shown here which is a very simple refillable product and it was supplied with some spare atomizers and one bottle of a liquid at the time that was before the TPD the European tobacco tobacco products Direction became binding we were able to use larger bottles so that was ultimately in the bottle which would last two to three weeks and people could ask for another one but very few people they'd only 7% is everybody then got their own illiquid and that was a strong advice we didn't want people to feel that this is what they have to use they were instructed to shop around try different illiquid silicates and cells are not expensive and they may prefer to have a different strength of a liquid different flavor and they may even find this particular device to their liking and they may want to buy a different one and in this very almost everybody switch straight away to other liquids and 75% of them also switched or different flavor resupply the tobacco flavor I think if we did this again or next time we would start this fruit flavor because these are the most popular but it doesn't really matter as long as people are encouraged and allowed to find their own and the cost of this during the studies this particular device was discontinued and the new one was a bit more expensive this is the more expensive one thirty pounds the original one was icing about 22 so the cost is much less than with NRT we go the reason of the follow-up rate you always lose some people in this type of studies weathers intensive face to face support because people who are not doing well eventually get embarrassed facing their adviser and telling them they still smoking and some people drop out and so we had a drop out but about 80% followed up which is similar to previous randomized control trials conducted within stop solving services there were three big studies done previously and you can see their full operates and so it was very similar and we analyzed it on intention-to-treat basis that means we assume that everybody not standing up is smoking and this is somewhat harsh assumption which you make in stop smoking studies but that's the current norm it's called the Russell standard approach with a few other ways on how you can calculate your outcomes but we also did multiple imputations and that showed very consistent results so first of all what did cigarettes do compared to nigga replacement treatment initially when we were still seeing these people once a week and we were able to monitor their withdrawal discomfort people on e-cigarettes had significantly less edges to smoke and the edges they still have are significantly less severe and now this is the active ingredient of all treatments we can and here for smokers who Pro P environment in the nickel replacement treatment they all do the same thing they reuse withdrawn discomfort and he cigarettes seem to do it better than an RT they also had lower increase in irritability restlessness concentration there were even differences in hunger and depression but these didn't reach significance by week four as we know when people stop smoking maintain abstinence or four weeks most of these things are back to normal so there was literally throw discomfort in in everybody who was quit but the rise to the four weeks that journey was much easier for people were using e-cigarettes EC girls also reduced better rating they were seen as more helpful and more satisfying compared to cigarettes than NRT so in summary we had good adherence in both of the answers in tributed slide but almost everybody use their product daily over the first four weeks in both NRT and e cigarette arm but then the big difference emerged as people carried on using e-cigarettes over the initial period while in NRT group they were gradually stopping using NRT in cigarettes received or favorable ratings so how does it translate to abstinence at one-year validated absence rates were over just over 18 percent or me cigarettes and just under 10 percent of NRT people who didn't quit and claimed to cut down by over 50 percent they were all invited in and that many who were confirmed to actually take 4 less toxins or inhaler smokers index by carbon monoxide reading and you can see again they read more in the cigarette and then in DNR TR this however does not provide totally full picture because within a year a lot of people we're clearly failing on NRT or funding quick Austin's difficult we're actually finding their way to e-cigarettes there were a few in the e-cigarette arm who ended up using a latte as you can see on this slide but many more in the NRC are using e-cigarettes so as one year although they were counted as if they quit due to NRT inside they quit due to cigarettes and that's difficult to handle one possible approach to this you just remove these people from the sample you can't reassign them because the original randomization you have to adhere to but if you remove these people from the sample then the difference between the two products becomes much more marked and now the rivet the ratio is over to the different with 8% and 18% now we noticed a thing which was remarkable in the NRT arm if you just look at abstainers 9% we're still using the NRT at one year and that's tallies with what we know from previous studies some people who are quitting with n RT need that crutch for a bit longer and carry on using an RT log 10 but in a cigarette arm we had 80% still very pain not all of them using nicotine cigarettes 24% now nicotine 356 percent using nicotine for many cigarettes those who were still using nicotine reduces the strength from 18 was the mean nicotine strength at the beginning and at 1 it was 12 we don't know whether that means a real reduction in nicotine intake or not they may have learned how to use their apparatus better or they may have bought better better devices which deliver higher nicotine level fever from lower nicotine liquid so we have this issue about 80% still vaping only 90 cents to using NRT is that the problem now it could be bad if this means that they are going to continue vaping for the next 20 30 years and some health risk emerges eventually an outcome back to the possibility of some risks from logged and vaping later on we know that over two years that no health risks have been noted that's the Cochran verdict and from some other studies and follow-ups we currently have it looks like about three years of vaping still no health risks but we don't know about twenty or thirty years so there is that possible negative sound on the other hand if this prevents relapse and we know that loads them in our to use prevents relapse so it's quite likely that long time a cigarette use would have the same function there will be a good thing it may also prevent discomfort although most people get over the craving for cigarettes and missing their cigarettes fairly quickly some people become veritable in there it may be example for a long time it may or we know that it does prevent weight gain and it may maintain some smoking rewards and I expect that most of these people who continue to wake did it primarily because they enjoy it so whatever it does for smokers whatever positive reinforcement it provides now they have an option to carry on obtaining that and so this needs to be balanced this is the potential possible healthiest if they carry on for decades hey I'm just going to give you a two-minute warning or they you might go over a little I guess ah okay so I better speed up adverse reaction nothing really to write home about respiratory symptoms this is very interesting people on e-cigarettes and less cough and swim these are signs of respiratory infection and it looks like there is a possibility that using e-cigarettes actually prevents you protects you from airborne infection and some hypotheses about it several studies reported earlier and this is an interesting effect needs to be still confirmed by some control trials but if that's the case that would again come to balance some of the potential health risks if it's at the same time protect you from airborne infection so speeding up I just go to possible reasons for e-cigarette superiority better withdrawal relief better subjective effects most likely also better nicotine Taylor when you give people in our t v– insist on them using just up to fifteen piece of chewing gum a day or whatever one patch a day here they can actually select how much nicotine they want exactly the same way as when they smoked it then cells decide how much according they want so better self titration and that's a nicotine a better tailoring of fruit tobacco menthol and so on flavors as well so the conclusion for practice would be the d cigarettes generate much higher quit rate than a naughty achieve it at lower cost and should become one of the treatment options of the way the services explain to people you're going to burn mclean or near aggression treatment appropriate they should also add p cigarette starter pack to the mix how long do i still have and when you at time but i we definitely want to hear the next few slides peter so if you could kind of go through them quickly that would be great okay so this is a trial where we don't have any results yet but it's sort of similar to the one i was just describing it was comparing cigarettes and and our teen pregnancy markers just a few words about safety of e-cigarettes in pregnancy the indica but most of this smoke is already consumed nicotine and in higher doses so NRT is widely used and there are some other chemicals in the e-cigarette but these are not expected to pose any risk to the Peters propylene vehicle is a proof for using pregnancy in asthma inhalers glycerine has no normal adverse effect them again glycerine syrup is fine in pregnancy and the trial includes very close monitoring of adverse events pregnancy outcomes so what do we do here and this is a busy slide so you may want to have a close look at it we have a research midwives in 23 sites identifying potential participants women who smoke and they are then run reminders interest in taking part in the trial are randomized and everything is done over the phone and by mail so they would be posted either a cigarette starter kit very much like something like I was showing you before or nicotine patch e16 our patches the instructions on how to use them they then get weekly phone calls and they get followed up at end of pregnancy and three months after delivery to assist adverse events or mother and baby since delivery we provide 16 hour patches cigarettes are refillable cigarettes tobacco this time they have a choice of tobacco or fruit flavored but again they're encouraged to find their own strengths and flavors if they preferred it and we based our calculations on 8 percent versus 14 percent quit rate and with trials recruiting about 1200 pregnant women so it's a huge big trial the recruitment is on target we recruit about half of participants so far follow completed about 200 follow-ups no adverse effects which should be considered related to the product have been noted so far but we have another year to finish recruitment and the results would be expected at the end of next year or early 2021 so that's all I've got great thanks Peter and so we've got lots of questions and we're now I'm going to be joined for the Q&A session by Linda and also Joe Locker from public health England Joe is the packet Control Manager at public counseling our senior Control Manager sorry Jay and hopefully we've managed to get Louie's hand the public health midwife from South T's to also join Louise can can um say hello we'll make sure we can all have joy our fantastic brilliant okay so we've got um lots of questions and I think I might like to kick off with a question about e-cigarettes for all of our panelists to think about so there's a couple of people who've asked this question so I'll sort of frame it broadly so there's a question around what advice and frontline staff can provide to pregnant women about using e-cigarettes and I'm just going to stick up on the screen as we talk about this the challenge group infographic Linda I wonder if you could come in first and talk a bit about what your advice would be to frontline Zadar around and speaking to women about who is making about you to the Guerette they're certainly so we produced a practical guide with the Royal College of midwives and I authorize you to others which I think most people will have seen that if you haven't it is on the challenge group website and it essentially is about three foldable pages that takes through takes colleagues through what basically what they can and can't say about e-cigarettes so and in a consultation worker I think talking about nicotine use in pregnancy in providing reassurance that it's not the nicotine that's harmful and it's fine to use alternative and that e-cigarettes are widely used and that people do find them helpful and there's good evidence in the general population and that it's far better that a woman beats than she smokes and clearly a health professional also needs to be very clear on a couple of other points they can't be prescribed because they're not available we don't have a product so they can only be bought by the woman unless the service offers a starter pack and which i think is unusual in pregnancy and then also that clearly we still have questions about pregnancy specific effects and outcomes and that there is a large trial underway but in the meantime if the woman is smoking now the priority is to support her not to smoke and vaping from all the evidence we have to date looks like a less harmful alternative so I think there should be a positive conversation thanks Linda Louise I wonder if you could add from your sort of experience and speaking to me because how you would talk to them about e-cigarettes how you would to action that advice yes certainly I think it's about having the right conversation as was said to remove any confusion for the pregnant women around the use of e-cigs that we support the use of e-cigs as a safer alternative to smoking and that we record them as a nonsmoker and just dispelling any myths around the use of e-cigs and any harmful effects as previously has been said lots of women unfortunately think that it's the nicotine that harms the baby and it's about having the discussion around the effects of carbon monoxide rather than nicotine thanks Louise and Peter will Joe do you have anything that you you'd want to add to that discussion about the advice we should be providing around e-cigarettes Peter I think I'll go along with what says yeah anything you'd add from a Phe perspective I think just to reiterate the two key points the said by both the comparator is always smoking so and these are women who were already highly addicted to highly dependent and using high levels risky levels of tobacco so the comparator here is always to smoking and also the latter point that if we do have a woman who switches completely to vaping then it's important that from a data perspective they're recorded as not smoking so if someone has switched completely then recording them as a nonsmoker booking or delivery or wherever you're collecting the data is really important as well thank you Joe and I think we have we have a few questions about this point around the role of nicotine in pregnancy a specific question I guess Linda this might be one for you whether neonates are being assessed for nicotine withdrawal symptoms when women are using it NRT in pregnancy and is that something that's been looked at I think we would expect to see no I really don't think in the UK we're assessing neonates what I mean obviously if a woman has been smoking during pregnancy there may be a whole variety things we want to assess with the infant but that's not something that's routinely done and there certainly are studies in the u.s. looking at babies being irritable and you know whether having a mom who smoked during pregnancy is related to some of that but not from the nicotine replacement therapy and as I say in terms of those follow-up studies the snapdragons along this follow up and there certainly that's not something recess it's not something we're concerned about and presumably that's true in there in the e-cigarette trial – Peter it's but it's not the concern that you would have well we we are following this pickup pose delivery and all these things are being very carefully assessed so we will have the answers eventually yeah I think the snap trial is very reassuring in this respect whether there is anything else cigarettes do on top of what patches do I suppose more of these women are likely to be vaping through pregnancy which touches they probably stopped using the patches early on the the adherence approach is very low in the snap trial so I think we will we will have definitive answers I think at the moment thinking back about this discussion about whether that is to recommend these cigarettes in pregnancy I think reassuring people and allowing them to use it is absolutely whether this whether we should start already proactively giving pregnant smokers e-cigarettes I think that's a matter of opinion at the moment I think you know the trial will provide different advances if it's safe as we think it is then it would be absolutely legitimate to do it whether to do it now before the trial results are in I think that's a call yes there is a distinction to be drawn between supporting women who are making that choice and proactively providing the products as part of a service yes sorry it is about emphasizing women these are consumer products that they may choose to purchase I think we are astraying into difficult territory before the prep child is provided to say that we should be handing these products out bringing them and another point that's been raised is a in to your presentation particularly Peter it's a sort of pattern of a different pattern of youth with each cigarettes compared to NRT the fact that people are likely to be using them longer term and the the that increases I guess our likelihood that women might be coming to pregnancy having quit in preparation for becoming pregnant but but becoming pregnant while they're vaping where are we what advice that we provide him to those women do you think who are coming to pregnancy having quit smoking but it's still vaping Peter there will be a sort of precautionary advice that it may be better not to wait if they are able to stop vaping during pregnancy as well would be my advice but if they refer to carry on vaping then of course it's much preferable to going back to smoking I would have a preference for nothing followed by vaping followed by smoking yes Linda would you add anything to that I mean if a woman comes to an antenatal appointment and she's vaping that means that probably well recently she's been smoking and we know that I mean there might be the old woman has been vacant for five years you know this is possible as well but we know because of the chronic relapsing nature of tobacco use in the prenatal and during pregnancy and the postnatal period and as Peter says in an ideal world nobody would be but if she's vaping she's probably a fairly recent egg smoker and the priority is to make sure she doesn't go back to smoking so I think that has to be a clear message the research question for Peter and I and for others is in terms of the fact that so many women relapse after they give birth will vaping during pregnancy a bit like Peters hypothesis about his for ongoing vapors in his text trial will this actually help us with this real big problem postpartum and katelynn not Lia University of East Anglia's just finished a small feasibility study that's looking at that and she's applying for more funding now Louisa it's not something that you have experience of in the services people arriving into pregnancy vaping and looking for advice certainly we do get ladies a book with us the first contact and have disclosed that there be pain and I agree I think it's really important that we have a key conversation with them around you know the the use of e-cigarettes however if they have recently stopped which in my experience it is it who they're using to quit smoking then you know we should praise them for that and be mindful of the fact that we don't want them to go back to smoking and also mindful of the fact that I was smoking stop smoking service can support them as well if they've recently quit smoking thank you I just moved back to the issue of nicotine again so we've a question about people women who might be more heavily dependent on cigarettes than others so if a woman smokes throughout the night would a 24-hour patch be considered Linde you mentioned the fact that the patches are not recommended for use during night during pregnancy something you could speak to yes certainly so I mean there's a difference between what we routinely advise not clinicians and what happens to practice you do tend in studies and the qualitative research that's being done that that's exactly what would then do you they know they're not supposed to use it overnight ideally but they find that it's not being that helpful so they do put it on at night so I think I really welcome the Mises perspective on this as a specialist and as an advisor and I think if women find that helpful we shouldn't be tutoring them from doing that there's this reasons why we advise not to but the risks are going to be very minimal Louise do coming to add on that Denise I haven't I haven't had much feedback from any patients I've looked after for through the night being a problem women are quite receptive to the patches and the second products along with that I certainly haven't had much experiences of so the night concerns but obviously a maternity services 24 hour and if we have a newly delivered patient then you know through the night is a time when they may require a first require a patch and so it's just clearing up any confusion for medical staff and midwives of when to actually apply that patch if the guidance is we can't use them at night well actually is that woman actually gone into periods of sleep at that time would it be beneficial for her to have that at that point and I guess that sort of speaks to the need to have a fairly nuanced conversation that is personalized to the smoker about this making and and the importance of specialists being involved and especially as midwives being involved in supporting pregnant women and I mean it presumably that look Jo I wonder if I could bring you in to talk a little bit about you know the importance of being able to have those more nuanced conversations with women and and the need to make sure that we have those things in place locally yeah I think I think you've covered it there I think the the individual support for women based on their smoking their quit journey and their pregnancy is really important and so having that Swift referral from the Midwife in the booking appointment or other antenatal appointments to someone with specialist stop-smoking training is is really important and that might be another another specialist midwife within the Maternity team or it might be out to the stop smoking service but but being able to have that longer conversation about what's right for that woman is is really important and I think the the model that we're we're looking at across that system to try and implement in in maternity services is where the midwives are able to have to raise the issue do the carbon monoxide monitoring and and have a brief conversation brief meaningful conversation with women about their smoking and also encourage them to attend and engage with the specialist support that's available so that they can have those more nuanced conversations and make sure that they get the right information right consistent information and can can choose a quitting method that's that's right for them really so I think that's that's really important about having that whole system approach where where where the whole maternity team and then the specialist stops making advisor or stop smoking service is engaged and accessed quickly so that we can have those those more detailed conversations I'm gonna make a little public service announcement from C Cooper from Washington University just to add a bit to what Linda said so she says just to mention a bit more information about the new program it's by Linda which is being led by Tim Coleman and in this study in addition to providing dual NRT there will be a multi factor tailored to support package to improve women's adherence to NRT and as that's probably one of the reasons why it doesn't work very well which is something you discussed by both Peter and Linda and so I will circulate the information about that program if people are interested in more information so you provide the links I will circulate that and we also have a specific question Peter about your trial so Peter are you looking for more pregnant women to be included in trial and how can local stops making services help to identify women at the moment the recruitment is fine but if we get some kind of recruitment fatigue in some sites and they are not recruiting well including new sites would be a possibility if there are services willing to chip in we would certainly like to hear from them okay so if you're on the line and you're interested in in Peters research there's no promises but let us know and we'll pass your information on to Peter and in case you get some recruitment fatigue and we've got a couple of specific questions which I think Louise maybe you would be better to answer and there's a question here about what we're talking about using 15 milligram milligram patches and what about the 25 milligram patches would we not be looking to use those in pregnancy within our trust we use the 25 milligram patches and the 15 milligram patches it depends on the assessment made by the Midwife at the time so the C you're monitoring and how many the patient smokes what we want is to have the right amount of nicotine in the patch for the patient so that they don't have all the cravings either whilst an inpatient are as an outpatient and then turn back to cigarettes it's all done on an individual basis and this is rolled out across maternity and then we've used maternity as a model for the trust smoke free nicotine decision erred as well so so again it's about tailoring the support to the woman in front of you and not presupposing and it would be a 50 milligram patch they would need or a 25 milligram or or a different product all together absolutely because you need agreement from the woman it needs to be a good discussion with the woman it needs to look at her needs and what actually is want even more successful for her rather than us said this is what I'm going to give you actually you should going to engage if we give her a product that isn't actually that appealing to her are what meet her needs and and I think a question for Peter and Linda perhaps so there's a question being asked about whether we would recommend or encourage a reduction plan which would be a nicotine reduction plan with the use of e-cigarettes it's very quite broadly but I don't know whether we would think about that just in relation to pregnancy you know more broadly would you recommend if smokers are using e-cigarettes that they taken an approach where they seek to reduce 11:18 over time and is that something you would also recommend in pregnancy Peter question to you first I personally would not I would let them to find the level of nicotine they find satisfying and and use that that may not be everybody's opinion when our paper was published in the New England Journal of Medicine this trial their editorial was saying okay then you know use e-cigarettes but make sure that people come of them as quickly as possible and they use only the lowest nicotine level they can possibly have and I think that's a counterproductive advice be that to worried about a slight differences level of nicotine are we worried about relapse and going back to smoke Linda would you ever need to add to that yeah I think there is a there's a bit of an obsession in the literature coming from the US about you know reducing the amount of nicotine in vaping and that's what everybody should be doing I mean we do see that in the population studies that that does tend to happen naturally anyway people want to reduce the nicotine this is not pregnant specific and but I know I would I would agree with with Peter probably particularly for this group actually you are at such high risk of relapse and that I I think the beginning of your question was more a bit more concerning to me hazel which is should we be endorsing a cutting down approach with vaping in pregnancy and you know our formal advice through the nice guidance pre cigarettes is that there really are no benefits to cutting down in pregnancy and that women should aim to stop completely and that that remains the message but clearly in practice you know what women do in practice often is start by cutting them rather than quitting completely and I think advisors are well-placed to deal with that I've been stood in Louise's view just one other comment I understand that you say that sue Cooper is on the line and just to acknowledge that soon LED that longer term follow-up analysis from the snapshot that's very much her work and so it's great that she's listening as well and me also be able to chip in but I yeah be just interesting the reason view on this you know women do cut down even though we're advising them to stop yes amazingly that's a very common occurrence that women are coming and saying oh well I've reduced the number of cigarettes I've smoked that's enough yeah very common lots and lots of ladies when we have the discussions with them we'll say or what I've caught down it's about the midwives being confident in the response to that and then and using say your monitoring is a great tool for that and actually showing them well you know we've launched ten or fifteen last time and you've cooked down and actually we're still seeing the same levels of say you're because you smoking the cigarette differently you know it's about education it really is about educating women in a non-judgmental way lately and trying to work in partnership with them as well to find an alternative course in dial and it strikes me it's not just about educating the women Joe I wonder if I could bring you in I know the various bits of work and research that we've done and together looking at professionals understanding both of nicotine and you know the benefits of cutting down you know there is widespread misunderstanding among professional groups here which could be undermining the successful quit attempt yeah I think I think that that's that's true and it's not we're not just talking about the midwifery and related workforce I think that some as evidence that there perceptions and misconceptions amongst a lot of health professionals about nicotine and and smoking and then of those message around cutting down which can all compound the pregnant woman receiving different messages from different health professionals as well as different members of their social networks and families as well which can be confusing so as you say a lot of the work that we're doing within the maternity space and then also looking at how we can get information and messages and training and guidance to other health professionals as well around that difference between smoking and nicotine and where vaping sits within that and why that that's that's different as well to make sure the largest sense as we can women will be receiving consistent messages about the risks of smoking during pregnancy and what what the what the difference is with in terms of nicotine use and also why switching or stopping smoking completely is is so important but if there it is a challenge and there are mixed messages out there and the trials and the quality of work that Linda was talking about earlier on clearly shows that another research then survey work that we've done with with health professionals tells us that we're still still work to do to ensure the consistent messaging is it's being given to women particularly from from the health care professional so they might engage with so we have developed new training and also in the process of developing a range of different training resources as well for different health care professionals because we know that people have different training needs training opportunities and time to engage with some of these resources so we've got online training modules available but we're also develop developing some short films and some and what we might call classroom resources so that those people who are holding local training sessions or maybe got a short period of time on a mandatory training session can dip into those and and use them use some of those resources to try and help our local teams to erm to be on message and also confident with with the messages around smoking cutting down nicotine vaping as well in the e-learning for healthcare platform will hope be hosting all of those resources as well as some really useful stuff on the NCS CT website briefings being updated as well as we speak okay sorry go and Peter we also run once a year an update for service practitioners and commissioners is Robert West and it's called the annual update and supervision course and it's the sort of continuing professional development type of thing and it typically has got the section on pregnancy and cigarettes are usually heavily covered because this is the main development the moment the events summarize new findings and your research over the year and what it means for practice and has got some kind of supervision of clinical practice in it as well it always they December and I suppose ash could give you details if you're interested we can we Amal we absolutely absolutely could will circulate information base about the things that Joe mentioned there and Peter's course as well and so we're coming to the last minute or so and I would just ask our speaker socialism for their contributions has been really interesting given a and if I'm just gonna say a few more words and I'm going to come to all of you very briefly and ask you for you know the one thing that you would like people to take away from from today's session the most important message that they could take away and but before I come and ask you that I just want to let people know that we will be circulating links to all these resources and the link to the smoke-free pregnant the information network so you can sign up and get regular updates we are also updating the challenge group e cigarette resources which areas people have alluded to and will be circulating those as well and there's also a webinar that's already your mind that Linda did a little while ago that was just on these cigarettes and said help me some more information in that if you want to listen to it so I will just come very very quickly rapidly around our speakers what's the one message that you want people to take away from today's session Peter I'll start with you I suppose my talk was about an evidence we now have any cigarettes can have smokers quit Thank You Jay I think that supporting our health care professionals to have the right knowledge and skills and confidence with them feel a lot of the information that has been presented today is really going to going to make a difference and if if people on the call can them and share the resources available with their teams that really help to to make a difference to that system-wide consistent approach Louise always loved the wave Linda one thing that you want people to take away confusion on nicotine on e-cigarettes in particular and you know midwives and health professionals are the two accurate information along with the challenge group resources and others so we have a real responsibility to try and communicate about nicotine and also e-cigarettes as clearly as we can brilliant thank you to all of the speakers and to Joanna Lewis for joining us for the Q&A session and for all of your questions and do sign up for our incentives seminar later in the month and we'll be in touch with all of the information that we've been discussing today thanks everybody

2 Replies to “Smoking in Pregnancy Challenge Group Webinar – Nicotine in pregnancy”

  1. Probably the most explanatory Webinar on the topic of nicotine in pregnancy that's emerged to date, I hope the veracity of this data changes the myopic perception amongst recalcitrant HCPs.

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