A national Tommy’s miscarriage trial platform

Arri Coomarasamy, Adam Devall, Jane Daniels, Siobhan Quenby, Helen Williams

With over 75 early pregnancy units already involved, Tommy’s are growing a network of researchers and doctors to help solve the problems surrounding miscarriage.

The PROMISE trial was the first ever miscarriage prevention trial to run on such a large scale. It involved more than 800 women, in the UK and beyond, and brought together doctors, academics, midwives, nurses and more.

We want to keep this momentum going in future trials. That’s why Tommy’s are helping set up a platform for miscarriage research that will be used across the country to help researchers and patients. Out network now includes more than 75 Early Pregnancy Units across the UK.

This project is essential for other trials like SIMPLANT and SIM, and will also help studies in which Tommy’s collaborates such as the PRISM and TABLET trials. Essentially, it will help to connect Tommy’s, and other, researchers all over the country.

We want to carry on growing this network, so that we can continue doing and sharing high quality research on a national scale. Through doing this, we can answer important questions about why miscarriage happens and how to stop it.

Thanks for your interest in our research

Tommy's funds research across the UK investigating the reasons for pregnancy complications and loss. Maternal and fetal research is underfunded and we need your support to continue. There are many small and large ways you can support us, find out more here.

The TABLET trial – testing the drug levothyroxine for lowering the risk of miscarriage

The TABLET trial aims to find out if taking a small dose of a drug called levothyroxine before and during pregnancy could lower the risk of miscarriage. It is a randomised, double-blind placebo-controlled study of more than 950 women from 60 centres across England and Scotland.

Researchers reviewed earlier studies and found that women who have thyroid peroxidase antibodies – a sign that their thyroids have an autoimmune problem - have a much higher chance of miscarrying. However, 2 studies showed that treating women with levothyroxine lowered this risk.

To prove these results, researchers set up the TABLET trial to find out if levothyroxine really does protect babies from miscarriage. If this is the case, it would be a major breakthrough for early pregnancy care. The American Thyroid Association has already said that “the TABLET study might well change recommendations.”

The TABLET trial is taking place in Tommy's National Centre for Miscarriage Research and funded by the National Institute for Health Research's Efficacy and Mechanism Evaluation programme. We have recruited women to the trial in both Manchester and London, as well as helping promote the study within our national miscarriage platform. 

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The PRISM trial – can progesterone prevent miscarriage in women with early bleeding?

The PRISM (Progesterone in Spontaneous Miscarriage) study aims to conclusively show if progesterone can stop miscarriage in women with early bleeding during pregnancy.

Progesterone is a hormone that is naturally made by the body, and helps to maintain pregnancy and regulate the menstrual cycle. There have been several earlier studies suggesting that giving pregnant women extra progesterone could stop miscarriage. However, many of these were small, and there isn’t enough evidence to say for sure.

Women with early bleeding will take either progesterone or a placebo twice a day, in capsules that can be inserted into the vagina. So far, more than 2,800 women from 47 hospitals across the UK are taking part, and the study aims to look at 4,100 women by mid-2017.

If PRISM shows that progesterone can stop miscarriage, this would be a huge breakthrough in miscarriage prevention. It is cheap, safe and convenient, and could save countless babies’ lives.

The PRISM trial takes place in Tommy's National Centre for Miscarriage Research and benefits from Tommy’s national miscarriage trial platform, through which Tommy’s have helped recruit women. It is funded by the National Institute for Health Research's Health Technology Assessment programme. 

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The MifeMiso trial – what is the best way to medically treat early miscarriage?

There are three different ways of treating an early miscarriage:

  • Waiting for it to resolve on its own (expectant management)
  • Taking medicine to help things along (medical management)
  • Having surgery to remove the pregnancy (surgical management)

Around 1 in 5 women in the UK choose medical management. However, it isn’t clear what the best way to treat women is. Before the current guidelines were published in 2012, most doctors gave women a combination of two drugs: mifepristone and misoprostol (the MifeMiso combination). The new guidelines recommended giving only misoprostol, however there wasn’t strong evidence why.

That is why the MifeMiso trial exists: to find out the best way to treat women experiencing a miscarriage. Researchers aim to study over 700 women at more than 30 hospitals. It is the largest study ever looking at medical treatment of miscarriage, and will transform clinical practice around the world.  

This research takes place in a Tommy's centre, and we have helped to recruit women through the national miscarriage platform. The trial was recently awarded £1.8 million in financial support from the National Institute for Health Research's Health Technology Assessment programme. 

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