A new way of conducting clinical trials to prevent miscarriage

Tommy’s researchers are developing a new way of testing treatments that could prevent miscarriage.
  • Authors list

    Professor Arri Coomarasamy, Dr Adam Devall, Dr Pedro Melo, Dr Jennifer Tamblyn, Professor Siobhan Quenby, Rajinder Kaur

    Start date: 2022
    End date: 2026

Why do we need this research?

We need to find new ways of preventing miscarriage. While clinical trials are the standard way of testing treatments and interventions, they can take a long time, be expensive to run, and sometimes thousands of women and birthing people need to take part, which can be difficult to achieve.

A simpler method of testing treatments and interventions is needed so that we can quickly find the best ways of preventing miscarriage.

What’s happening in this project?

Building on the success of the Tommy’s Net project, our researchers are developing a new way of testing interventions that may prevent miscarriage.

In normal clinical trials, some people get the treatment that is being tested and the rest get standard treatment. Usually, each new treatment needs its own clinical trial with a separate group of participants.

Our researchers want to see whether it is possible to use a ‘cohort multiple randomised clinical trial’ design – or cmRCT – to test new treatments that could be used to prevent miscarriage. Instead of setting up separate trials for different treatments, the team will use the Tommy’s Net database to assess many different treatments in one large group of women, called a cohort. The idea is that new treatments could be given to different, randomly picked groups of women from the cohort, with their outcomes being compared to those in the cohort who received ‘regular’ treatment. This means that researchers don’t have to recruit new people for each trial, saving time and money.

To test this new process, Tommy’s researchers want to carry out a ‘pilot’ study to find out whether the cmRCT design gives them the information they need to assess the effectiveness of a new treatment. Having already shown that vitamin D deficiency is associated with miscarriage and recurrent miscarriage, our team will now use the cmRCT design to test whether treatment with vitamin D can improve the chances of a successful live birth in women with a history of recurrent pregnancy loss.

Our researchers also want to expand Tommy’s Net to other miscarriage clinics in the UK, which would increase the number of women and birthing people available to take part in future research studies.

What difference will this project make?

Our researchers hope that this new way of conducting clinical trials will allow them to quickly find out which new treatments show most promise and should be investigated further in larger, definitive clinical trials. This should make miscarriage research much easier and faster, allowing new tests and treatments to be rolled out quickly to women and birthing people across the UK.

Thanks for your interest in our research

Tommy's funds research across the UK investigating the reasons for miscarriage, stillbirth and premature birth. We can keep you updated on ways you can support our work. If you would like to join our fight against baby loss and premature birth, click here.