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

    Dr Adam Devall, Professor Arri Coomarasamy, Professor Siobhan Quenby, Professor Phillip Bennett, Professor Jan Brosens, Dr Rima Dhillon-Smith, Dr Ioannis Gallos, Dr Stephen Quinn

    Start date: 2021
    End date: 2026

Why do we need this research?

We need to find ways of preventing miscarriage. Clinical trials can be used to test treatments and interventions, but they can take a long time, be expensive to run, and sometimes thousands of women need to take part, which can be difficult to achieve.

New methods of testing treatments and interventions are needed so that we can 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 to prevent miscarriage.

In normal clinical trials, some people get the treatment that is being tested and the rest get standard treatment. Normally, 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’ – or cmRCT – design to test new treatments that could be used to prevent miscarriage. Instead of setting up separate trials for different treatments, the team will use Tommy’s Net to gather together one large group of women, called a cohort, that can be used to test many different treatments. 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 of the women in the cohort who received ‘regular’ treatment. This will mean 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 small ‘pilot’ study to find out whether the cmRCT design does indeed give them the information they need to assess the effectiveness of a new treatment. In this study, women with a history of recurrent pregnancy loss will be tested for vitamin D deficiency prior to pregnancy and will be treated where necessary. The team hope that this ‘test and treat’ strategy will improve the chances of these women having a successful live birth.

Following the pilot study, our researchers want to carry out other small trials to quickly find out which new treatments show most promise and should be investigated further in larger, definitive clinical trials.

What difference will this project make?

Our researchers hope that this new way of conducting clinical trials will make miscarriage research much easier and faster, allowing new tests and treatments to be rolled out quickly to women 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.