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The large AFFIRM study, which is looking at the way maternity units respond to women with reduced fetal movement (RFM), has started. Thirty-six units from different parts of the British Isles are taking part: 15 in Scotland; 12 in England; 5 in Wales; and 4 in Ireland. The study, which is part funded by Sands, is comparing what happens before and after maternity units start to follow a specific pathway of care for responding to women who say their baby’s movements have reduced. It also involves emphasising to women the importance of contacting their midwife or unit straight away if they think the movements have changed. A similar study in Norway in 2005–7 found that the stillbirth rate was almost halved in women with RFM when women reported a change in movements promptly and the pathway was followed. Professor Jane Norman at the Medical Research Council’s Centre for Maternal and Fetal Health in Edinburgh is leading the AFFIRM study.
Sometimes women whose baby is stillborn report that their baby had become less active in days before their baby died. It’s common, however, for women to wait for up to 2 days before they mention it to their midwife or doctor. Would a campaign to highlight the importance of reporting a reduction in baby’s movements (RFM) straightaway help the maternity team identify babies who need immediate help?
Before maternity practices can be changed, we need to have evidence from research studies that the change will benefit babies and/or mothers and families. Norway introduced a service improvement several years ago encouraging women to be aware of their baby’s movements and to immediately contact her midwife should she be concerned. Medical teams acted promptly with improved management of these pregnancies to check whether there was a problem. The number of stillbirths in Norway dropped significantly after the new service was introduced. But managing RFM in this way has not been assessed in an in-depth research study. We need strong evidence to understand all the effects of such a protocol. Will it help reduce the number of stillbirths? Will it make women with a healthy pregnancy overly anxious? Will maternity teams be able to cope with an increase in phone calls from concerned women who may or may not need further checks?
WHAT IS THE PROJECT TRYING TO ACHIEVE?
The project, called AFFIRM (Does Promoting Awareness of Fetal movements and Focussing Interventions Reduce Fetal Mortality?) is being undertaken in a step-wedge design, which means that participating maternity units will put into practice new guidelines and management of RFM one by one. Information will be collected about the pregnancies and their outcomes both before and after the new protocols were put in place in the different units. The new protocols will highlight the importance of keeping a track of baby’s movements during pregnancy. Women will be encouraged to contact the maternity team if baby becomes less active and the team will have a consistent action plan to follow when a woman contacts them with RFM.
Researchers will collect information on the number of stillbirths before and after maternity units started using the new protocol. They will also collect data on the number of caesarean sections and women whose labours are induced. Maternity teams and pregnant women will be asked their views on how the scheme has worked.
The results of this study will provide vital information that may support a change in current maternity practice.
WHO IS CONDUCTING THE RESEARCH?
The principal investigator on the AFFIRM project is Professor Jane Norman, who works at the University of Edinburgh Medical Research Council (MRC) Centre for Reproductive Health. The project team also includes:
- Dr Catherine Calderwood, Medical Adviser, Scottish Government Health Department
- Professor Sarah Cunningham-Burley, Head, School of Molecular, Genetics and Population Health Sciences, University of Edinburgh
- Janet Scott, Head of Research and Prevention, Sands
- Dr Christopher Weir, Associate Director (Statistics), MRC Hub for Trials Methodology Research, Edinburgh
- Dr James Chalmers, Consultant in Public Health Medicine, NHS National Services Scotland
- Dr Edile Murdoch, Consultant in Neonatology, NHS Lothian Trust
- Dr Sarah Jane Stock, Clinical Lecturer, University of Edinburgh
- Dr Mary Ross-Davie, Educational Project Manager, Midwifery and Reproductive Health, NHS Education for Scotland
- Professor Fionnuala McAuliffe, Head, Women’s and Children’s Health, University College Dublin, and Consultant Obstetrician, National Maternity Hospital, Dublin
- Dr Michael Geary, Consultant in Obstetrics and Gynaecology, Rotunda Hospital, Dublin
- Dr Alyson Hunter, Consultant Obstetrician, Royal Maternity Hospital, Belfast
- Dr Alexander Heazell, Clinical Lecturer in Obstetrics, University of Manchester
- Dr J Frederik Frøen, Director, Norwegian Institute of Public Health
AFFIRM started in January 2014 and will end in March 2017.
- Holm Tveit JV, Saastad E, Stray-Pedersen B et al. Maternal characteristics and pregnancy outcomes in women presenting with decreased fetal movements in late pregnancy. Acta Obs Gyn Scand 2009;88:1345–51
- O'Sullivan O, Stephen G, Martindale E, Heazell AE. Predicting poor perinatal outcome in women who present with decreased fetal movements. J Obs Gyn 2009;29:705–10
- Tveit JV, Saastad E, Stray-Pedersen B et al. Reduction of late stillbirth with the introduction of fetal movement information and guidelines - a clinical quality improvement. BMC Pregnancy Childbirth 2009;9:32
- Warrander LK, Heazell AE. Identifying placental dysfunction in women with reduced fetal movements can be used to predict patients at increased risk of pregnancy complications. Med Hypotheses 2011;76:17–20