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Anyone participating in 35/39 study?(32 Posts)
I've been invited to take part in a research study of women aged over 35 who are having their first baby. Basically they are trying to see whether all over 35s should be routinely induced at 39 weeks in order to reduce the likelihood of women over 35 needing an EMCS.
If I sign up I will be randomly allocated to one of two groups - a group who will be induced at 39 weeks (assuming LO has not already made an appearance) and a group that will be induced at 41 weeks.
I think participating in research studies is really important - this is an IVF pregnancy and I'm very conscious that I have benefitted from the women before me who have participated in research.
Any ideas on what the pros and cons for me would be if I participated? Is induction a particularly unpleasant process? If I participate it seems to me that at least I know I will be induced if needed at 41 weeks at the latest. Equally, I'm finishing work at 36 weeks so would be happy and ready for LO to arrive at 39 weeks.
The info about the study is here
What would you do.....?
This may be of interest to this thread.
Induction of Labour at Term in Older Mothers (Scientific Impact Paper 34)
This Scientific Impact Paper (SIP) looks at the induction of labour in women of advanced maternal age (40+ years) and the possible benefits of inducing at an earlier stage of gestation (39-40 weeks).
With the average maternal age in the UK rising dramatically over the past two decades, there have been numerous studies undertaken to establish a link between rising maternal age and the increased risk of obstetric complications, increased risk of stillbirth and neonatal deaths.
This paper examines a collection of these studies, comparing fetal and maternal outcomes in women of advanced maternal age in the UK.
It is suggested that it would be justifiable for experts to conclude that inducing labour at an earlier stage of gestation in older mothers could improve perinatal outcomes and eliminate possible maternal risks of an ongoing pregnancy in women of advanced maternal age.
This Scientific Impact Paper can be downloaded
Another paper i looked at held opinion that induction of labour does not cause the risk of c. Section to increase. I will try and post this link.
There is an interesting document if you google 35/39 trial launch meeting (it's a .PPT document and I haven't been able to link directly to it, but it's easy to find).
Probably best not to read if you are pregnant and facing induction, but it does refer to the consultation of Mumsnet for opinions on the study before it started, and there are also some rather tasteless photos used to illustrate things such as woman in agony due to being induced.
I too would be fascinated to read the ethics approval for this research. I'd be especially interested to know why an epidemiological study was not proposed, and why anonymised data cannot be collated from hospitals on the existing outcomes. To be honest this strikes me as horrific research on live human subjects. The pain of an induction, the greater likelihood of needing intervention and the long term health risks from that intervention are things that women and their primary carers have to balance against clear and present risks in a pregnancy. Its seems a dangerous and unreasonable thing to ask a woman to do unless all other resources in gathering data had been exhausted. I would leave the care of anyone who recommended my joining such research on principle.
Update from me - was pregnant when last posting. Went into labour last weekend at 40+9 and ended up being induced due to PROM, and baby arrived with epidural/forceps delivery.
Obviously did not participate in this study, but ended up participating in Bumpes study, relating to birth position with epidural.
I need time to gather my thoughts about the whole experience, and will come back to this thread when I have more time, but found the pressure to be induced one of the most stressful things I endured during my pregnancy.
Hope you are all enjoying your pregnancies and all is going well. such exciting times ahead for us all. I see the main reason for this research study is to see if the likelihood of needing an emergency c.section in labour is reduced in the over 35 age group if they are induced at 39 weeks; rather than those in the control group being induced at T +10-12. that is if they have not gone into spontaneous labour. (37 weeks onwards being term). Induction for those in the intervention group, at local trust would probably be performed at 39+6, the day before due date , as long as it still in the 39th week this is accepted for this study. For those who are randomly allocated to the control group, local policy is T+12, their plan of care would be exactly the same if they were not in the study. The only difference would be the confidential gathering of their data with respect to the study outcomes. Research is great and i agree with your post and the findings will be of much benefit to many women in the future. Only with such research will the evidence be ever generated. A lot of questions remain unanswered and with studies continuing it is hoped many will be answered in time to come. Statistics apparantly show a linear relationship between age and delivery by emergency section. ? WHY???. Hopefully this study could provide some insight into some aspects of this question. If the questions are not asked we will never know.
Some women actually request early induction for various reasons so for them being in this study thay would hope to be in the intervention group. As with all research studies you are free to withdraw without reason at any time. Some women may withdraw from this study if they are not allocated into their preferred group. What is certain is that if a women was in the group to be induced at T+ 12 but required induction earlier if any complications/ concerns developed then this would be performed if medically requested. Likewise someone who is in the early induction group decided against this when the induction date was looming, this again would be her own decision.
I also agree that anyone who feels very strongly about being induced early would not be a suitable participant as the researchers would not want anyone to do anything they did not agree with or would be unhappy with. as with all research studies participation is totally voluntary and from discussions about this study any decision is not required until later on in pregnancy, entry can be made up to 39+6 . Some women may feel different about this as their pregnancy progresses. It is also true that many different trust policies differ and consultants practices vary within regions and trusts. some consultants offer early induction to women over 40, but should they? where is the evidence. Perhaps this research may find it or at least contribute to answering the question. This research may help to standardise practice for all women. if it is found to be safer to induce women earlier without a rise in emergency c. sections this could be offered to women as a choice in the future. If it is found to cause any increase again, this will help to provide the evidence for the trusts to base their policy on.
induction of labour is already performed early for many women, diabetic, obstetric cholystasis, prolonged rupture of membranes and the benefits outweigh the risk. I believe the researchers believe that the same intervention may be of benefit to women over 35 . A lot of food for thought. what other research is going on in your local trusts?
So, I went for my dating scan today and was whisked away to be briefed on this one. I've taken the information sheet away to mull over. There's more detail on it than on the website and it is clear that the best medical pathway will be followed for you regardless of condition. I'm thinking of if like this - control = no difference to what would have happened anyway and you will be induced earlier if your condition requires it. Intervention = induction but no evidence that this is worse for baby. Still not sure how they deal with drop out which will be high if its both voluntary znd clinically driven. I'm wavering - will give a vote to OH though he's currently leaving it to me!
Yes Duchesse all the factors you mentioned are potentially confounding hence, I guess why they want to do a randomised control test. I don't work in medical research so I don't know exactly how these things play out but essentially you can withdraw from any human research at any point so they may well lose all the intervention group if the baby is small at 39 weeks and the parents change their mind.
Lozster - I have been 40/41 years old throughout my pregnancy too. I have been consultant-led too, but this is for an existing medical condition which has caused no issues whatsoever during my pregnancy. I don't know if consultant-led care based solely on age is another regional variation? I got the impression I wouldn't have had one, other than for my medical condition.
You are definitely right about age not being the best factor on which to base induction. The last obstetrician I saw said they see slightly more stillbirths in older women but they don't know why, hence the lack of factors taken into account, other than age.
By the way, if you are worried about testing now that you have got past the 12 week mark, please make sure you are aware of the discussion about Harmony testing, which you will find in Antenatal Tests and Choices. Sadly, it only became available in the UK in September so too late for me to take advantage but it might offer you some reassurance and remove some of the angst connected with invasive testing.
I do wonder if they've thought this through adequately. "Older" mothers are more routinely viewed as being high risk whatever the actual state of their health (I got amazingly close antenatal care for DD3 at age 40) so are more likely to end up giving birth in a large consultant unit (vs a midwife led unit or birth centre), where potentially interventions are carried out more readily that might or might not lead to CS. Also statistically more women will deliver by CS in a consultant unit than birthing centre for obvious reasons. Have they actually scrutinised the reasons for doing CS on older women? Older mothers hence more "precious" baby as reproductive time running out may mean women more readily consent to CS or intervention. Is there is any concrete evidence to suggest that mere age (rather than medical indications) is a major factor in stillbirth and CS?
Meanwhile, should someone break the news to the Nottingham Clinical Trials Unit that people generally think their trial sucks? They've recruited 47 participants so far, but wonder if this number will drop a bit now? They are looking for another 600 or so women to take part!
Eagle ray I am 40, will be 41 when, all being well, first (only!) child will be born. I am a research scientist and write proposals for human reseach. I certainly wouldn't have phrased the info like that though ethics groups can be idiosyncratic on what they deem 'acceptable' so I can see how it has gone through.
I'm not sure age is the best (only) factor for deciding to induce. I am just over 12 weeks now so when I've got over my anxiety about miscarriage and my angst about ante natal tests I can see this being a good substitute to fret about. In terms of risk my age automatically puts me in consultant led care however, age is my only risk factor. I honestly look at some young, overweight, smoking, drinking women and think surely I can't be that bad in comparison?
Hi Swanlike - I get stillbirth risks mentioned to me all the time, although no one as yet has been anything other than vague about the exact risks/statistics. Also, I have been in great health during this pregnancy - no risks apparent other than my age.
No one can force an induction so it is likely the Cambridge hospital you mention has a policy of recommending it or offering it, but they can't do it as a matter of course without consent!
You may find this older thread useful www.mumsnet.com/Talk/childbirth/a1353115-Quick-unscientific-poll-early-induction-due-to-maternal-age as it will give you an idea of the differing experiences of women over 40, and I think it might point to some research/statistics.
Difficult to say why policies vary so much from one area to the next. I live in an area where the average age for having a baby is well above the national average, and am hazarding a guess that Oxford and Cambridge might be along the same lines but have no idea what effect this has on how a hospital manages risk or formulates policies.
Meanwhile, hope you have a great birth (before someone pops up to offer an induction!)
Interesting, I'm 41 and 38 weeks pregnant and no-one has mentioned increased risk of stillbirth to me. Is there any recent research on this? That said, at the first hospital I went to in Cambridge they said that they induce all women over 40 at 40 weeks as a matter of course but didn't give a reason beyond it being 'safer'. I've moved to Oxford and this hasn't been mentioned at all and they seem happy for me to go over 40 weeks just like anyone else.
I should add that my last child born when I was 41, was an EMCS but that was NOTHING to do with my age and purely to do with the passenger messing around with her cord for a few weeks before birth (I guess she got bored...)
I would definitely say no in answer to your original question. Be informed and arm yourself with as much information as you can is my advice.
I personally wouldn't volunteer to possibly be induced at 39 weeks as my babies are never "cooked" until 42 and being premature by 3 weeks would be an unacceptable risk to me. Also what happens if their induction doesn't work? Do they proceed through the usual range of interventions, which might ultimately include a CS for failure to progress? I'm frankly surprised they got permission to run a study like this.
Hi Lozster - I was wound up by that too
and wondered if I was reading a Daily Mail headline
How old are you, if you don't mind me asking? There is a lot of pressure on women over 40 to be induced but it's not something they can enforce, and policy does seem to differ between individual health care professional, hospital, health authority and so on.
The increased risk of stillbirth is oft quoted by the health care profession, but not the actual figures/research this is based on (and I have tried to ask!)
You are right about the baby's individual development - I think more focus should be given to that (and the health of the mother) rather than just processing you as an 'older' person and therefore automatically at greater risk.
It doesn't seem right to me to experiment on women and babies with a procedure that can be downright dangerous and higher chance of emcs anyway. Why risk it I don't know.
I thought the literature was pretty badly written, lozster. I agree that some of it was quite scary, and I didn't think the reasoning for the research was explained at all.
On your point about induction at 39 weeks being the norm - well no-one's mentioned it to me at all, and I'm 36 weeks now.
Thanks for all the replies - as ever MN offers sounds advice
On balance I'm not going to participate in the study. It just seems insufficiently clear on what they are trying to achieve and how this study will really help and what the potential implications for participants are. I agree that it's surprising this has been approved from an ethical POV.
I'm intrigued to read this as the midwife vaguely mentioned this at my booking in appointment. She didn't elaborate, I was too overwhelmed by the amount of information being thrown at me to ask for fyrther explanation, however she seemed to imply that induction at 39 weeks was the norm anyway.... Afterwards this struck me as odd as surely it depends on your baby's individual development?
I've had a look at the link and maybe I'm being an over sensitive older mum but the very first para wound me up
'British women are increasingly delaying childbirth. The longer they wait the greater the risk of pregnancy complications. One concern is the increased risk of stillbirth (baby dying before birth).'
Also, I ignored the poster for months as thought that the 35/39 bit referred to women aged 35-39 years old and therefore I would be too old. Maybe they should have road-tested the name of the study
I have seen the literature for it in my local hospital when I have been there for MW appts. Must admit I read the leaflet with enthusiasm (I'm 41 and due tomorrow) until I read the bit about being randomly allocated to a group and induced at 39 weeks!
I know that this research is related to the raised risk of stillbirth in older mothers, as well as CS (stillbirth risks get mentioned a lot during my appointments) but have struggled to see what the point of this research really is.
Armadillo - if my brain was working properly, I think I would have drawn the same conclusions as you did about the study. I understand that more research needs to be done around older mothers and CS/stillbirth risks but think it needs to be better than this. Especially given that I get stillbirth risks stated to me a lot, but this information is never backed up with any statistics/information. The NICE guidelines on induction make no reference to older mothers either!
I must admit I'm a bit crap with interpreting research and usually read the abstract and that's enough for me but the way I understand it, you are at a higher risk of having a section if you are induced so I'm not really sure what they are hoping to achieve with this study. You have group A (the control group) who the researchers hypothesise (that's a word?) will go into labour when the time is right and will have a naturally occurring proportion of EMCS, then you have group B) who they are using to try and prove you should induce at 39 weeks to avoid EMCS, except in trying to prove it they are using a tool that is shown to increase the instance/likelihood of requiring an EMCS. It just seems to be a bit counter productive if you ask me, plus at 39 weeks, some babies aren't completely cooked and depriving them of that extra Inutero time for no medical reason also seems a bit, well, stupid.
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