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.
Why do we need this research?
For babies who are growing more slowly than expected in the womb, it is not clear whether they would benefit from being delivered at the first sign of a concern or whether doctors should wait for longer. We think that by combining blood flow assessment in baby’s brain with ultrasound measurements, we can get better at identifying the babies who are truly at increased risk and who would benefit from an early delivery.
Stillbirth late in pregnancy and developmental issues in young children are more likely in babies for whom there are possible warning signs of problems during pregnancy. Warning signs include growth restriction, when the baby’s size doesn’t increase as expected during pregnancy, and heart rate and/or blood flow changes.
What are the aims of this study?
Our study will look at whether delivering babies early, as soon as there are signs of problems, is better for the baby, compared with waiting and continuing to monitor. In general, babies benefit from going through a full pregnancy, as there are health risks linked with being born prematurely. However, for babies growing more slowly than expected in the womb, there are also health risks linked with delivering the baby after a full pregnancy. This study is looking at the balance of these risks to see what makes early or full-term delivery the better option for different babies.
What will the researchers do?
Mothers of babies who are smaller than expected, growing more slowly than expected, or who have early signs of changes in blood flow near the end of pregnancy (32 weeks or later) will be invited to join the study. The babies will be closely monitored and if there are changes in the blood flow to the baby’s brain, the mother will be assigned to one of two groups. They will either continue to be closely monitored with scans as usual, or the baby will be delivered early. If any baby in the study suddenly becomes unwell while being monitored, they will be delivered as soon as possible.
The health of the babies will be recorded at birth, and their development will be checked when they are two years’ old using a questionnaire. This will make it possible to compare the immediate and longer-term impacts for the baby of either being delivered earlier or later.
Sands is a co-applicant for funding and has been involved in reviewing the study design and information. Sands will continue to be involved in the research and will help share the results of the study to the public.
What do we expect from the study?
This study is looking at the balance of the risks linked with continuing the pregnancy or delivering the baby early. By measuring blood flow in the baby’s brain with ultrasound measurements, can get better at identifying the babies who are truly at increased risk and who would benefit from an early delivery.
Lead researcher – Professor Cristoph Lees
Institution – Imperial College London
Funder – National Institute for Health Research (NIHR)
Duration – December 2019 - November 2024
Find out more on the study website.
The research team have also made a video explaining the study.