The AFFIRM trial for prevention of stillbirth
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Authors list
Dr Elizabeth Camacho, Professor Jane Norman, Dr Sarah Stock, Professor Alexander Heazell
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Research centre
Start: January 2014
End: June 2020
This project took place at our Edinburgh centre which operated between 2008 and 2021.
Why do we need this research?
The rate of stillbirth in the UK are among the highest in the developed world. A 2016 study in The Lancet ranks it as 26th out of 49 high-income countries. Tommy's believes that this is unacceptable.
Most of the time, stillborn babies appear to have grown completely normally. Often, it is only discovered after birth that there was something wrong with the placenta: the organ that provides babies with the oxygen and nutrients that they need in the womb. An early sign that something might have gone wrong is if a mother notices that her baby is moving less than usual – this is known as reduced fetal movement.
Tommy’s have been supporting a trial to try and prevent stillbirth from happening, by focusing on women who report their babies are moving less than normal.
The AFFIRM trial
The AFFIRM trial, which ran from 2014 to 2016, aimed to see whether a simple ‘care bundle’ can reduce stillbirths by raising awareness of, and acting on, reduced fetal movement.
The AFFIRM care package was made up of:
- information for pregnant women raising awareness of monitoring reduced fetal movements
- more tests and clinical help when babies are moving less than normal.
The study generated huge interest, involving around 450,000 pregnant women across the UK. The results of the AFFIRM trial showed a small drop in the rate of stillbirth among women receiving the care package. However, this drop wasn’t large enough to be completely certain that it was caused by the care package, rather than being caused by chance.
Watch this video to learn more about the results of the AFFIRM trial.
What’s next for the AFFIRM trial?
Our researchers are now carrying out an analysis to show whether the AFFIRM care package is cost-effective to implement, compared to standard care. The team will be assessing the cost of extra resources needed to provide the care package, including additional scans. Along with the results of the trial, the cost-effectiveness analysis will provide policymakers with the information they need to decide whether to implement the care package across the NHS.
What difference will this project make?
If the care package studied in the AFFIRM trial is found to be cost-effective, it could be implemented it across the NHS. This could provide women whose babies are moving less than normal with additional support when they need it, and potentially help to reduce stillbirth rates in the UK.
More research projects
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Research into stillbirth
When a baby dies after 24 weeks of gestation, it is called a stillbirth. Nearly 3000 families a year get the devastating news that their baby is not alive. Our research is helping to change this. -
Assessing how healthy babies are when they start moving less than normal (FEMINA2)
Reduced fetal movements are a common reason for women to go to hospital in the last 12 weeks of pregnancy. There is currently no way to know which women will have a normal pregnancy and which have problems. -
Assessing how healthy babies are when they start moving less than normal (FEMINA3)
Reduced fetal movements are a common reason for women to go to hospital in the last 12 weeks of pregnancy. But there is still no way to accurately tell which women will have a normal pregnancy, and which will have problems. -
Bile acid levels increases the risk of poor outcomes of pregnancies with intrahepatic cholestasis of pregnancy (ICP)
Researchers have looked at information from 5,500 women with ICP, finding that the babies of women with high bile acid levels are most at risk of stillbirth. -
Can low levels of taurine make stillbirth more likely?
Tommy’s researchers are looking at how the lack of an important nutrient might harm the placenta during pregnancy, putting women at a higher risk of stillbirth. -
Can steroid injections improve blood flow to babies at risk of stillbirth?
Finding out whether steroids can improve the blood flow through the placenta -
Comparing 2D and 3D MRI to study the placenta
Our scientists are developing new ways to use MRI scans to study the placenta, so that we can understand how it works and how its structure and function change during pregnancy. This will help us prevent complications like stillbirth and miscarriage. -
Could beetroot juice be used to treat fetal growth restriction?
Fetal growth restriction is often caused by reduced blood flow across the placenta. Researchers funded by Tommy’s have found that beetroot juice, which is rich in a nutrient called nitrate, could potentially reduce blood pressure and improve blood flow to placenta.