TABLET trial - anyone taken part?

LJ9982

Hi everyone,

I recently suffered a miscarriage and received a call from a midwife at the local hospital asking me if i wanted to take part in a trial happening all over the country called TABLET - summary below:

TABLET trial summary

TABLET is a large double blind placebo controlled trial to be run across approximately 20 UK sites. This trial is testing the hypothesis that taking a small (50µg) dose of thyroxine by euthyroid women aged between 16 and 40, with thyroidperoxidase (TPO) antibodies, before and during pregnancy, will increase their chance of delivery beyond 34 weeks of gestation by 10%, compared with the placebo.
A systematic review of literature has found that thyroid antibodies are associated with miscarriage and pre-term births. Recruitment will be taking place in miscarriage clinics and infertility clinics in hospitals in England and Scotland. We will be asking women who have miscarried, and plan to be actively trying to conceive within the next year, and more recently, women who are being treated for infertility, to have a screening blood test for thyroid antibodies. Women whose tests indicate that they are TPO positive, and are euthyroid, will be asked to consent to be randomised into the trial. We anticipate that we will test over 5000 women, to randomise 900 into the trial. The intervention of 50µg of thyroxine or placebo will be taken daily for up to one year, whilst the woman is trying to conceive, and throughout the pregnancy. Thyroid function (TSH and Free T4 levels) will be closely monitored at regular intervals throughout the trial. Women whose thyroid function results fall out of the ranged defined by the Trial Management Group will be withdrawn from the trial, and treated according to standard guidelines.


I popped into the hospital to see her and read the fact sheet. For now, myself and my partner aren't sure if we will be TTC in the next 12 months as we haven't decided when we are going to try again yet - too soon for right now BUT i did have the blood test done as i was there anyway which came back normal thyroid hormone levels but positive for the antibodies - so I am a perfect trial candidate.

Not sure what to do..... like I said, my OH and I aren't sure if we are going to try again yet so not sure if i should opt to take part.... but not sure what next step i should take regardless. If my thyroid is producing these antibodies, it could be the pregnancy that triggered them and these antibodies could attack a future pregnancy...... or something else triggering them - wondering if my doctor could help?

fluffnutter

Do you have details on the exact trial dates? If you start TTC in 11.5 months does that make you eligible for the trial? A year's a long time, you've only just experienced a horrible loss so it's not surprising you're undecided on when to try again but in my experience most women give it another go before the year's out.

I'd find out some more details and then probably go for it personally. They'll have drop outs, trials always do, so don't feel too worried about your circumstances changing. I'm happy to participate in trials but it's very much a personal decision.

As an aside, I don't think this is something your GP would get involved with. Miscarriages are sadly very common, it's not usual practice to investigate until you've had a number in a row and GPs are pretty rubbish with fertility issues anyway.

hawk30

I certainly would. I know you are probably feeling pretty raw right now, as it's a horrible thing to experience, but you may find you want to start trying again in a few months. We always started trying ASAP after each miscarriage as it made me feel better, but everyone is different.

LJ9982

fluffnutter wrote: »

Do you have details on the exact trial dates? If you start TTC in 11.5 months does that make you eligible for the trial? A year's a long time, you've only just experienced a horrible loss so it's not surprising you're undecided on when to try again but in my experience most women give it another go before the year's out.

I'd find out some more details and then probably go for it personally. They'll have drop outs, trials always do, so don't feel too worried about your circumstances changing. I'm happy to participate in trials but it's very much a personal decision.

As an aside, I don't think this is something your GP would get involved with. Miscarriages are sadly very common, it's not usual practice to investigate until you've had a number in a row and GPs are pretty rubbish with fertility issues anyway.

Hi Hun

The trial has been going on for a while all over the country for the last couple of years though my local hospital are newer to it than some. they are hoping to test i think 5000 women and trial 900 of them. again you don't know if you will be given the levothyroxine or the dummy drug (my understanding). I could opt to take part yet be given the dummy drug.....

I am obviously just worried that these antibodies could potentially attack a future pregnancy and obviously i'd like to do anything i can to try and avoid that.....

I know miscarriage is very common and the reasons around them are unknown etc - and it may not be these antibodies at all - but the main thing on my mind is that the thyroid is producing the antibodies even though my hormone levels are normal..... so something is triggering this - could be pregnancy/could be anything. CONFUSED!!

fluffnutter

Of course. It's natural for you to be confused and every woman wants to know why if she's suffered a miscarriage. The thing is, they don't know. That's one of the reasons they're conducting this trial. In taking part you might find the answers you need. You might not of course, your next pregnancy might be problem-free regardless. Baby-making's a tricky business with lots of unknowns.

When do you have to decide by?

Rottensocks

LJ9982 wrote: »

Hi Hun

you don't know if you will be given the levothyroxine or the dummy drug (my understanding).

Yep, its double blind, so neither you nor the person giving you the medication will know whether you have meds or placebo.

I can't advise whether you should go for this trial or not, but I believe that normal NHS procedure is that you would need to suffer 3 miscarriages before they would start considering any serious investigation/assistance.....:(

LJ9982

Thanks everyone

I am considering the trial completely seperate. As i said, i don't know if i will end up with the medication or the dummy meds regardless... and like you say, pregnancy has lots of unknowns as does miscarriage and no-one knows why they happen.

It's not so much wanting to associate the miscarriage with this - i am not thinking that way. Am just concerned that my body is producing these antibodies and wondering if this is something i can go to the doctor with and get them to investigate outside of everything else

Lara44

Hello LJ9982

I too had the blood test after a miscarriage in the summer. While the results were coming in I had a good think about possible next steps. I had provisionally decided to participate if my sample had antibodies. In the end, the sample had few antibodies, so we didn't need to go any further.

It might be good to make another appointment with the trial midwife to ask these questions. Mine was super friendly and really encouraged me to get in touch with questions. I would have thought she would be more informed than a GP. Maybe she can pass on some of the research, or direct you to further resources? I am sure you are also concerned about your health in general, as well as possible impacts on future pregnancy.

I just want to send you super massive hugs, it's such a sad loss and I hope you're doing okay xxx

fluffnutter

LJ9982 wrote: »

Am just concerned that my body is producing these antibodies and wondering if this is something i can go to the doctor with and get them to investigate outside of everything else

It's not usual policy to investigate a single miscarriage. Sorry, sweets, but I don't think you'll have much joy with this at the GP's. I know you want answers, but sometimes there aren't any.

Noctu

No advice but I have to say that if what you pasted is from the participant information sheet, I'm disgusted! It should be written in lay language.

LJ9982

fluffnutter wrote: »

It's not usual policy to investigate a single miscarriage. Sorry, sweets, but I don't think you'll have much joy with this at the GP's. I know you want answers, but sometimes there aren't any.

I meant outside of everything else as in outside of the miscarriage. What i am trying to say is that i know miscarriage is common and my miscarriage might not have even been caused by this. what i am trying to say is that worrying about my general health and having these antibodies, i was wondering if going to see my gp and mentioning the bloods results, whether they might do anything about this..... i am just thinking of my future health!