The Preterm Trials Consortium: using long-term trials to answer difficult questions

Professor Andrew Shennan, Ms Jenny Carter, Dr Helena Watson, Dr Rachel Tribe

Tommy's is setting up a platform that will help researchers study premature birth more effectively.

Research into premature birth is a tricky task. To get results that you can trust, you need long trials that look at large numbers of people. If an illness is rare, or it is difficult to find people to take part in research, it can be hard to test which treatments work best. To make things harder, a lot of funding for research is given for relatively short periods of time: often too short to find meaningful answers, or understand long-term effects.

Tommy’s want to change this.

We recently supported a study that lasted 8 years to test whether the cervical stitch helped women with cervical problems carry their babies to full term. The study was a success, but showed us that to answer questions like this, we need big studies over long periods.

The MAVRIC study led to the idea of the Preterm Trials Consortium (PTC). This will be a platform for many different centres, recruiting large numbers of women to lots of studies and following them for long periods. By setting this up, we can do more to find answers to the many difficult questions still surrounding premature birth.

The PTC platform went live in December 2016, with nine centres currently collecting data for this project. So far, 608 women have given permission for their data to be stored on the platform. We hope to see more centres join the platform in the near future.

Examples of questions that the PTC might try and answer include:

  • If the cervical stitch can help women who have 'bulging membranes' – when the sac of fluids surrounding the baby pushes out a little through the cervix. This increases the risk of a woman’s waters breaking early, and can lead to premature birth if it happens early in pregnancy
  • When to remove the cervical stitch in women whose waters have broken
  • The best way to deliver a premature baby that is positioned to come out feet first 

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Read more - the STORC study

Sometimes, the membranes holding the fluids that protect the baby in the womb can 'bulge' out of the cervix and into the vagina. This is caused by an 'incompetent cervix': when the cervix begins to open too early in pregnancy.  At the moment, there isn’t agreement on what to do when this happens. This is largely because there simply isn’t enough research to support particular treatments.

It is possible to perform a small surgical procedure called a 'rescue cerclage,' where a stitch is inserted into the cervix to keep it closed and stop the membranes from coming through. In the Tommy’s Prematurity Clinic in London, this is routine. However, in other centres across the PTC it is more common for women to just be prescribed bed rest.

Using the network of centres across the PTC, we can now look at which treatment is better by observing many women over a long time, some of whom will have surgery and some who won’t. In the end, we can find out which course of action will give the baby the best chances of surviving in these cases. 

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This study takes place in a Tommy's centre and is funded by Tommy's and the NHS innovations Challenge Prize Fund

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