RCM response to the publication of the AFFIRM trial in the Lancet

on 28 September 2018 Stillbirth

The Royal College of Midwives welcomes the publication of this important cluster randomised trial today in the Lancet. The AFFIRM trial has aimed to explore how we can reduce the number of stillbirths. Reducing stillbirths is a vital goal that the RCM fully supports – any stillbirth is an absolute tragedy for any family.

The AFFIRM trial used an innovative and robust design to test the impact of a package of care to reduce stillbirths and perinatal mortality. The study sought to test whether, by raising awareness  about the importance of fetal movements among pregnant women and health professionals and introducing  a consistent package of care when women present  with a history of reduced fetal movements, that stillbirth rates could be reduced. The study was large, including outcomes from more than 409,000 pregnancies in 37 maternity units across the UK.

The results of the study are clear: the package of care did not lead to a statistically significant reduction in the number of stillbirths and led to a significant increase in medical interventions including induction of labour and caesarean section. Induction of labour rose from 35.9% in the control period to 40.7% of births in the intervention period. Caesarean sections rose from 25.5% to 28.4% in the intervention period.

The RCM fully supports research and quality improvement initiatives to reduce stillbirths and neonatal death. The AFFIRM trial suggests that a reliance on reduced fetal movements alone will not lead to the reduction that we all wish to see in the number of stillbirths and neonatal deaths. The AFFIRM trial, with its negative result, has made an important contribution to our current knowledge. Further research into this important topic is always needed.  Current quality improvements initiatives underway in the UK, including ‘ MCQIC (Maternity and Child Quality improvement collaborative) in Scotland and the ‘Saving babies lives’ care bundle in England, take a multi-faceted approach to reducing risks, including supporting women to give up smoking, improving risk assessment and surveillance of fetal growth, effective monitoring in labour, developing a safety culture with positive multi-disciplinary team working and implementing continuity of carer, alongside increasing awareness about fetal movements.

The results of this study should not lead to a situation where a woman’s concerns about her baby’s movements are not taken seriously. We would still encourage all pregnant women to become familiar with their baby’s usual movements and to contact their midwife or maternity unit if they notice a change or reduction.  We would also still encourage all midwives, GPs and obstetricians to respond when women describe a reduction in their baby’s movements, taking a careful history and monitoring the baby’s growth, heart rate and activity in a face to face assessment.

The risks posed by increased interventions need to be balanced by their potential benefits. This study did not demonstrate that the interventions tested provide the benefits sought in relation to reducing stillbirth or perinatal mortality. There was also an increase in the number of admissions of babies to special care baby units for more than 48 hours after the intervention compared to before. 

The RCM supports ongoing research and quality improvement work alongside our colleagues in the multi-disciplinary maternity team. We hope that the findings of the AFFIRM trial will be considered carefully and will support health professionals in providing women with evidence based information to make informed decisions about their care.

Note to editors

The RCM is the only trade union and professional association dedicated to serving midwifery and the whole midwifery team. We provide workplace advice and support, professional and clinical guidance and information, and learning opportunities with our broad range of events, conferences and online resources. For more information visit the RCM website at https://www.rcm.org.uk/.