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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.....?
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.
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!
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?
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.
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.
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.
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.
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