The DESiGN trial: Does the Growth Assessment Protocol (GAP) find the small babies that are at risk?

We want to find out if changing the way we assess fetal growth can tell us which small babies are really at risk, and help us to reduce the chances of stillbirth.
  • Author's list

    Dr Dharmintra Pasupathy, Professor Jane Sandall, Paul Seed, Dr Annette Briley, Dr Matias Vieira; Dr Sophie Relph, Dr Asma Khalil

    Start date: 2016
    End date: 2019

  • Research centre

  • Research status

    Ongoing projects

Why do we need this research?

Some babies are smaller than expected given how long they have been growing in the womb. This is known as being ‘small for gestational age’. In some cases, being small for gestational age could indicate that the placenta is not working properly, putting a baby at higher risk of being stillborn. In fact, nearly half of all stillborn babies in the UK weigh less than expected. However, some small babies are actually completely healthy, and are simply small because of other factors such as the size of their parents.

We need to find better ways of telling when a small baby is really at risk, so that we can give it the best chance of a healthy birth.

Growth Assessment Protocol (GAP)

A few years ago, researchers developed a new way of customising growth charts that takes into account other factors that might affect a baby’s growth, such as the size and ethnicity of its mother. Through a programme called the Growth Assessment Protocol (GAP), maternity units have been trained in implementing these customised growth charts, as well as in other measures that improve the way they measure fetal growth. Early studies suggest that maternity units that have adopted GAP are better at spotting small babies that are at risk, and areas with a high uptake of GAP had a 22% reduction in the number of stillbirths.

However, it’s possible that other factors may have influenced these results. There is also concern that customised growth charts could classify some abnormally small or large babies as normal. Because of this, our researchers are now conducting a clinical trial to prove for certain whether GAP has any effect on stillbirth rates.

What’s happening in this project?

DESiGN is a randomised controlled trial that is aiming to find out whether the GAP programme really does help clinicians spot the small babies that are at risk. Hospitals that are taking part in the DESiGN trial have either carried on using their normal methods to track fetal growth during pregnancy or have switched to implement GAP. The last baby in the trial was born in February 2019 and our researchers are now assessing the impact that GAP had on stillbirth rates at these hospitals, as well as the costs involved in implementing the programme. The team have also interviewed maternity staff and women to gather their opinions of the new methods.

What difference will this project make?

This project will find out whether this change to the way we assess fetal growth really does help to identify the small babies that are at risk of stillbirth. If the results of earlier studies are confirmed, implementation of this new protocol could significantly reduce stillbirth rates in the UK.

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