TRUFFLE 2 – when is the best time to deliver babies experiencing problems in late pregnancy?
This trial is investigating when it is best to deliver babies who are growing more slowly than expected in the womb.
Some babies grow more slowly than expected in the womb. Such slow growth can be a warning sign about the overall health of the baby. Slow growth can be picked up by plotting regular measurements of the mum’s tummy on a graph, or seen on an ultrasound scan. If slow growth is found, doctors can then monitor the growth and health of the baby using other methods (such as measuring the blood flow to their brain), but there is no treatment to improve slow growth in the womb. The only thing that can be done for the baby is to deliver them, but it is not always clear whether they would benefit from being delivered at the first sign of a concern or whether doctors should wait until nearer full term. There are health risks associated with both early delivery and full-term delivery for babies who are growing slowly, so this study is looking to find the best time to deliver in order to balance out these risks.
The study aims to do this by randomly putting women whose babies are growing slowly into two groups: the babies in one group will all be delivered early whilst those in the other group will continue to be monitored, and delivered at full term (or earlier if doctors feel this becomes necessary for the baby’s safety). The health of the babies at birth and their subsequent development at two years of age will be recorded and compared across both groups to see whether early or later delivery is better for the baby overall. This study is taking place across Europe and families from many different countries will be involved, giving as large a sample as possible for comparison.
Sands has been involved in reviewing the study design and participant information sheets. Sands continues to be part of the group running the research, feeding in the patient perspective and will help to work out the best way of communicating the results of the study to parents, families and the wider public.
Could you take part?
The TRUFFLE 2 study is taking place at hospitals in the UK and internationally. Pregnant people whose babies are smaller, or growing more slowly than expected between 32 and 36 weeks of pregnancy will be invited to take part in the research if they are receiving care at one of the hospitals enrolled in the study (see the map below for UK hospitals). The video below explains more about what's involved if you are invited to take part. More information is also available on the study website.
You can also see a map of all the hospitals in the UK where the TRUFFLE 2 study is taking place.