The DESiGN trial: does the growth assessment protocol (GAP) find which small babies are at risk?

Dr Dharmintra Pasupathy, Professor Jane Sandall, Mr Paul Seed, Dr Annette Briley, Dr Asma Khalil; Dr Matias Vieira; on behalf of the DESiGN consortium

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.

Why do we need this research?

Most babies that die before birth seem to have developed normally, but many weigh less than expected. A baby that is smaller than normal for its age is known as small for gestational age, or SGA. A small baby may mean that the placenta hasn’t been working properly, and could be at a higher risk of stillbirth. However, some small babies are completely healthy, and are growing normally.

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

Growth Assessment Protocol (GAP)

Telling when a baby is too small and might be in danger can depend on things like the size and ethnicity of its mother. Researchers have developed a new way to customise growth charts, so that they into account these other factors that might affect a baby’s growth. A 2013 study showed that using these new personalised growth charts to find out which babies really are too small can halve the risk of stillbirth.

The Growth Assessment Protocol (GAP) is a training programme designed to help maternity units implement these customised growth charts, along with other measures to improve the way they measure fetal growth. Recent early studies suggest that units which adopt GAP are better at finding which babies are at risk, and areas with a high uptake of GAP had 22% fewer stillbirths.

However, it’s possible that other factors may have influenced these results. Therefore, our researchers are now conducting a clinical trial to prove whether GAP has any effect on stillbirth rates.

What’s happening in this project?

DESiGN is a randomised control trial that aims to find out whether the GAP programme really is better for finding out which small babies are at risk. Hospitals which are taking part in the DESiGN trial will either carry on using their normal methods to track fetal growth during pregnancy, or will switch to implement GAP. Our researchers will assess the impact that GAP has had on stillbirth rates at these hospitals, as well as the costs involved in implementing the programme. The team will also interview maternity staff and women to gather their opinions of the new methods.

What difference will this project make?

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

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