The AFFIRM trial for prevention of stillbirth

Researchers supported by Tommy’s are looking at whether a package of care and resources for pregnant women can help stop stillbirths.

  • Authors list

    Dr Elizabeth Camacho, Professor Jane Norman, Dr Sarah Stock, Professor Alexander Heazell

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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    Women suffering from diabetes are much more likely to suffer from stillbirths. We want to understand how high blood glucose can affect the growing baby and the placenta, so we can focus on helping women with diabetes to have safe and healthy pregnancies.
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  • Preventing stillbirth: the role of the immune system in rejecting the placenta

    Tommy’s are studying chronic histiocytic intervillositis, which causes the immune system to reject the placenta, leading to stillbirth or miscarriage.
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  • Can low levels of taurine make stillbirth more likely?

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  • Understanding how the womb lining matures during pre-eclampsia

    Pre-eclampsia can lead to health problems and sometimes stillbirth, but we don’t know enough about what causes it. Our researchers are studying how the lining of the womb develops during early pregnancy. This could reveal new ways to prevent pre-eclampsia and reduce the risk of stillbirth.
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  • Homing peptides: targeting drugs to the placenta

    Drugs which could help prevent pregnancy complications can’t reach the placenta effectively. Tommy’s researchers are making use of ‘homing peptides’ to deliver drugs directly to the placenta. This work could help to prevent pregnancy complications and stillbirth.
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  • Stillbirth and fetal free haemoglobin

    Researchers supported by Tommy’s have found that the substance that usually carries oxygen around our blood may have harmful effects on the baby when it escapes from red blood cells.
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  • ReMIT-2 – a feasibility study for spotting the early signs of complications

    We need better ways to spot the early signs of pregnancy complications. The ReMIT-2 study laid the foundations for a large clinical trial of a blood test which could predict which women need urgent care to prevent stillbirth.
    ReMIT-2 – a feasibility study for spotting the early signs of complications