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Anyone experienced the nightmare of Misoprostol/Cytotec to induce labour?? (long message)(22 Posts)
I am posting this on behalf of my friend who was given Misoprostol as part of a trial back in December 2001 when her waters broke but contractions didnt start. This was suggested as a good alternative to going on the drip so that she could walk around etc The nightmare was that the contractions started two hours later and were immediately 2-3 mins apart and hideously painful and strong and carried on the same for 15 hours. She gave birth to a healthy girl but has since then been diagnosed with post traumatic stress and has frequent flashbacks etc Doing some research on the internet we have found many stories of ruptured uteruses and that the drug is not actually licensed for use for induction of labour.
Does anyone have experience of this or know the latest situation regarding the licencing of this drug? It seems that hospitals want to use this as it is cheaper and seems quicker than traditional forms of induction.
This is very worrying for all of us as the hospital we both attended are planning to introduce this instead of the drip for all inductions.
Thanks a lot
Surely you can say that you don't want this form of induction, if they insist then change either hospital or consultant, after all, you CANNOT be forced to do something you don't think is safe for both you and the baby
Misoprostol is still not liscenced for obsteric use and any woman would be within her right to refuse it. It is still undergoing trials. The manufacturers do not condone its use other than for the treatment of arthritis
Thanks for these messages. Obviously now that we are aware of this drug will certainly not take it again but at the time none of this was known. Also it is rather worrying that it is not licenced for this use but is being used. We have found quite a lot about this on the internet and have requested further information from the hospital including copy of the consent form. Was just wondering whether anyone else has had this and any advice what to do next - surely the hospital should have told her all the risks etc
Mnafwood, definitely try nd get hold of the consent form, and also she should have been given a patient information sheet which described what the trial was about, and why it was being carried out. If the study had been arranged properly it should have gone through an Ethics Committee who would have decided whether enough information was given to the patients. She should definitely have been told that it was a clinical trial and that this wasn't actually licensed for this use at this time (which is why they were doing the trial). The new drug should have been trialled against the existing best treatment and if it comes out much worse than this (pain etc) in all the trials it undergoes, it shouldn't get licensed for the new use (ie for induction). I don't think another hospital could give it to you without consent if it hasn't got a license for this purpose.
Manfwood - this is interesting and worrying. Which hospital is this?
I know this is very worrying but would rather not reveal the name of the hospital at the moment as my friend wants to contact them and doesnt want anyone else to say anything to them at the moment - she is trying to find as much info as possible and also get hold of the consent form she signed before taking her next step.
For your info it is in the south east of England.
Is your friend making a complaint to the hospital? Sounds outrageous that she has suffered so much as a result of being given an unlicenced drug. Has she suffered financial loss as a result of everything - eg had to stop work because of ptsd? Does she want compensation for all that she has gone through? Only ask as I can personally recommend a very good lawyer who specialises in this sort of thing and would kick the hospital's butt big time.
Thanks for your mail. The current situation is my friend has written to the hospital asking for a copy of her consent form and whatever else she was/should have been given and she is trying to find as much as possible about it before contacting the hospital again. We also need to find out if it was a hospital/drug company trial or the drug was just being used 'off licence' which apparently is not illegal. She wasnt planning to go back to work so there are no financial issues. I also have a couple of friends who previously worked for drug companies who may also do some digging for me. Will keep you posted though when she hears back from the hospital.
In the meantime would be very interested to know if anyone else has been given this drug in similar circumstances.
Just a quick update - my friend has now heard back from the hospital. She got a copy of the form she should have signed but not her actual signed copy (strange?) and it seems that she was not told anything about the risks etc therefore it was not informed consent. She has spoken to Sheila Kitzinger and also AIMS (Assoc for Improvement of Maternity Services) who say she may have a case of some kind. She is writing to the hospital to get copies of all her notes and also seeing her GP so can get referred about PTSD. I've printed her something from the AIMS website about making a complaint and someone from AIMS is contacting the hospital regarding their Ethics committee. The trial was not a hospital trial as such but being run by two consultants. The good news is that my friend at least feels that she is getting somewhere.
Still strange that have found no one else who has been given this drug in labour?
She could try a small ad in the back of her local paper perhaps, asking people to come forward if they used this drug in labour. The paper might pick up on it and ask to run with the story but I guess she would be very careful if she was making a complaint at the same time.
If it was a trial run by two consultants only then prob you won't find anyone here, only in the local area, do you think?
There are quite a few articles on Pubmed about misoprostol and labour - type those two words in to get results.
manfwood, nothing to add other than this sounds outrageous. I hope your friend gets somewhere with her complaint. If they didn't give her the signed form it sounds suspiciously like they don't have one to me.
Thanks for your messages - although obviously this occurrence was a small trial but there is so much about it on the net that i am sure there must be more people who have been given it. As i mentioned she has spoken to the chair person at AIMS who is going to do some investigating and also speak to her GP.
Thanks for your advice
Manfwood> was it The Royal Berks?
If so unfortunately I've been involved in their complaints process, and might have some information. Chief Executives name etc.
Also know a good solicitor who specializes in medical negligence.
I seem to remember being asked to sign a consent form for the use of a new drug on clinical trial, with the birth of my daughter in 1998 (C&W). I refused, because there were one or two (can't remember) people in my antenatal class who had given birth up to 3 weeks before me who had signed it, and been given it, and had extremely fast and uncontrolled, traumatic and painful labours, and who had been told by the midwives afterwards that "yes, it seems to happen that way with this one". In the end they just broke my waters and it happened naturally - although I had to fight a bit not to be given the other normal drugs to start labour as well.
If this is the same drug then there must be at least 5 years of anecdotal and clinical evidence about this.
just re-read my meassage - just to clarify it was a drug for induction, and it ws chelsea and westminster. and I'm fairly sure it was for my dd (born march 1998) and not my son (Oct 2000) although I wouldn't swear to it. As I say, I didn't sign it despite two visits from doctors to tell me about the benefits. I'm the daughter of two medical parents, one of whom is an ob/gyn, and when I told them that they gave up (it has a magical effect on the medical profession - I guess they think you are either well informed or well connected medically and therefore they tend to go along with what you want.)
no it is not Royal Berks although it is near there - are you local to that area? Apparently they are not trialling this drug. HOpefully you can understand why dont want to give the name of the hospital at the moment. Thanks for the offer of the solicitor - will let you know how it is going and whether it gets to that point.
Sounds like may be something similar - Misoprostol seems to have been given in labour for a few years - especially in the US but still not licensed for that purpose. The thing is my friend was not told any of the risks and was just told it was like going on syntocin drip only she would be able to move around - that was it and she didnt think to ask any more. her waters had broken but contractions didnt start. With me they applied the gel a couple of times and then contractions started my waters broke and it only took a few hours. Her labour was really painful but also very drawn out so her epidural ran out before the final stages.
anyway - thanks again and will let you know how she gets on and may be in touch again soon.
I'm really dredging my memory now, but I think they way they tried to sell it to me was that it was "more efficient" and "more effective" than syntocinin, and I think they also said it didn't involve a drip.
Anyway it sounds like there is clearly a case to answer - In my cynical fashion I would be greatly interested to know if you do ever see your notes. My mother, who is a gp in london, has had 2 cases recently of horrifically mismanaged births (with tragic consequences) where the hospital "lost" the notes when asked for them. Obviously can't tell you the name of the hospital, but I was shocked when I heard. Best of luck!
Manfwood> yes I'm in Reading. The solicitorsthat I used specialise in medical accidentsand will not progress with a case unless thy feel it is necessary. They are very keen on negotiation, rather than going for the "money"..either for themselves or their clients.
By the way, once you have officially lodged a complaint through the correct channels, you have every right to access to your medical records. If they are not forthcoming, that is something they would have to answer for in itself.
Thanks for your replies. Obviously this is not going to be classed as a 'medical accident' but something to do with the fact that my friend was not given 'informed' consent. So Bobbins your solicitors probably wouldnt be appropriate if it comes to that but thanks very much for the info. I must stress that this did not happen to me but to a friend I met through my NCT classes who had a little girl the day before i had ds. She has been talking about how awful the birth was for such a long time and only recently discovered that it may have something to do with misprostol. Since finding out about the history of this drug she is obviously very angry that she was not told of the risks etc but at the same time at least she can now see that there was a reason she had such a terrible labour and that next time it probably wont be as bad.
Anyway - will let you know how she gets on with getting copies of her records.
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