Results from the AFFIRM trial into fetal movements and stillbirth

Tommy's news, 26/09/2018

AFFIRM, a trial examining the effect of using a care package to reduce the risk of babies being stillborn, has shown that it may offer only marginal benefit. Advice to women stays the same however: if you notice a reduction in your baby's movements consult your midwife or local maternity unit immediately.

Background to the AFFIRM study

• Failure of the placenta is a common cause of stillbirth. The placenta delivers oxygen and nutrients to the baby. If this supply is reduced, the baby conserves energy by moving less.
• Up to a half of women who had a stillbirth reported that they had noticed reduced movements of their babies in the womb in the lead up to it.
• A research study in Norway found that encouraging women to pay attention to their babies’ movements, combined with a care package and early delivery of babies at risk, helped to cut rates of stillbirth by 30%.
• The AFFIRM study was a large randomised clinical trial research trial to see if the same effect could be found again in a more stringent study. It used data from 400,000 women at 33 hospitals around the UK and Ireland.
• It is the largest study into maternal awareness of fetal movement combined with a care package to date.

How the AFFIRM study worked

• Women were offered either the normal care or a special AFFIRM care management plan.
• The AFFIRM care plan involved:
  • educating clinical staff about the link between reduced movement in the womb and risks of stillbirth
  • raising awareness amongst mums-to-be about monitoring reduced movement and reporting it immediately
  • more checks and scans to monitor growth of babies at risk
  • early delivery of the baby when the benefits were likely to outweigh the risks.

Findings from the AFFIRM STUDY

• There was a marginal drop in the stillbirth rate, from 44 in 10,000 births after standard care to around 41 in 10,000 births with the intervention. The effects were too small to prove that the intervention had been beneficial.
• More women were induced early and there were higher rates of caesarean section deliveries in the group that received the care package.

Researchers stressed that advice for pregnant women remains the same. If you notice a reduction in your baby's movements report it immediately to your midwife or local maternity unit.

Study lead Professor Jane Norman, Director of the Edinburgh Tommy’s Centre at the University of Edinburgh, said:

The study was designed to detect an effect of 30% or greater. The results suggest that if there is a beneficial effect, it is much smaller than this. It is not possible to say with certainty that the intervention has any effect on reducing rates of stillbirth.

The research adds further evidence to suggest that being aware of baby movements may help to marginally reduce risks of stillbirth, but it is unlikely that this strategy alone will be reliable for monitoring the well-being of babies in the womb. Other interventions will likely be needed to reduce stillbirth rates worldwide.

Professor Alexander Heazell, co-investigator on the study and Director of the Tommy’s Stillbirth Research Centre at the University of Manchester, said:

There are a number of other ongoing fetal movement awareness studies. Results from the AFFIRM trial should be analysed in conjunction with those studies before recommendations can be made on wider implementation of this approach.

An estimated 2.6 million babies are stillborn each year around the world. In the UK, around 1 in 200 pregnancies end in stillbirth, around 9 babies every day.

Up to a half of women whose pregnancy ends in stillbirth report reduced movements of their babies in the womb in the previous week.

Jane Brewin, Chief Executive of Tommy’s, said:

We know that reduced baby movements is associated with the placenta not working so well and the baby’s health being compromised. The advice for mums-to-be remains the same – if your baby’s movements change please consult your midwife or local maternity unit immediately.

The study, published in The Lancet, was funded by the Scottish Government’s Chief Scientist Office, Tommy’s and Sands.

More research into stillbirth reduction

The AFFIRM trial is one important piece in the jigsaw of evidence about the best ways to reduce stillbirth. The evaluation of the Saving Babies' Lives care bundle looked at a similar approach that was put into practice in maternity units across England, finding that it reduced stillbirths by as much as a fifth. 

There are two separate ongoing trials that may shed more light on the merits of care packages centred around awareness of baby movements as a strategy for reducing stillbirth rates.

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