Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
AFFIRM
1 other identifier
interventional
430,830
2 countries
29
Brief Summary
Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth. The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial. The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedFebruary 8, 2018
February 1, 2018
3 years
January 15, 2013
February 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of stillbirth
36 months
Secondary Outcomes (4)
Rates of caesarean section
36 months
Rates of induction of labour
36 Months
Rates of admission to the neonatal intensive care unit
36 Months
Proportion of women with fetal growth restriction
36 Months
Other Outcomes (1)
Acceptability of package of care to pregnant women and their health care providers
36 Months
Study Arms (2)
Current treatment
NO INTERVENTIONCurrent education and management protocols will be followed
A package of interventions
OTHERA package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth
Interventions
A package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth
Eligibility Criteria
You may qualify if:
- The study will include all women delivering at one of the maternity units involved in for the duration of the study.
You may not qualify if:
- Women delivering in the "washout" period in each unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
Study Sites (29)
National Maternity Hospital
Dublin, Ireland
Rotunda Hospital
Dublin, Ireland
Stepping Hill Hospital
Stockport, Cheshire, SK2 7JE, United Kingdom
Royal Gwent Hospital
Newport, Gwent, NP20 2UB, United Kingdom
Saint Mary's hospital
Manchester, Lancashire, M13 9WL, United Kingdom
NHS Lothian
Edinburgh, Lothian, EH54, United Kingdom
Birmingham Women's Hospital
Birmingham, West Midlands, United Kingdom
St. Richards Hospital
Chichester, West Sussex, PO19 6SE, United Kingdom
Worthing Hospital
Worthing, West Sussex, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, Yorkshire, United Kingdom
NHS Grampian
Aberdeen, United Kingdom
Neville Hall hospital
Abergavenny, United Kingdom
Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital)
Bangor, United Kingdom
Royal Jubilee Hospital
Belfast, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
NHS Dumfries and Galloway
Dumfries, United Kingdom
NHS Tayside
Dundee, United Kingdom
NHS Greater Glasgow
Glasgow, United Kingdom
NHS Highland
Inverness, United Kingdom
NHS Ayrshire and Arran
Kilmarnock, United Kingdom
NHS Fife
Kirkcaldy, United Kingdom
NHS Forth Valley
Larbert, United Kingdom
St Georges Hospital
London, United Kingdom
NHS Borders
Melrose, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Betsi Cadwaladr University Heath board (Glan Clwyd)
Rhyl, United Kingdom
Royal Albert Edward Infirmary, Wigan
Wigan, United Kingdom
NHS Lanarkshire
Wishaw, United Kingdom
Betsi Cadwaladr University Heath board (Wrexham Maelor)
Wrexham, United Kingdom
Related Publications (3)
Camacho EM, Whyte S, Stock SJ, Weir CJ, Norman JE, Heazell AEP. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a trial-based and model-based cost-effectiveness analysis from a stepped wedge, cluster-randomised trial. BMC Pregnancy Childbirth. 2022 Mar 22;22(1):235. doi: 10.1186/s12884-022-04563-9.
PMID: 35317772DERIVEDNorman JE, Heazell AEP, Rodriguez A, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Froen JF, Geary M, Breathnach F, Hunter A, McAuliffe FM, Higgins MF, Murdoch E, Ross-Davie M, Scott J, Whyte S; AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018 Nov 3;392(10158):1629-1638. doi: 10.1016/S0140-6736(18)31543-5. Epub 2018 Sep 27.
PMID: 30269876DERIVEDHeazell AEP, Weir CJ, Stock SJE, Calderwood CJ, Burley SC, Froen JF, Geary M, Hunter A, McAuliffe FM, Murdoch E, Rodriguez A, Ross-Davie M, Scott J, Whyte S, Norman JE. Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM). BMJ Open. 2017 Aug 11;7(8):e014813. doi: 10.1136/bmjopen-2016-014813.
PMID: 28801392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jane E Norman, MD
University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2013
First Posted
January 28, 2013
Study Start
January 1, 2014
Primary Completion
December 31, 2016
Study Completion
September 30, 2017
Last Updated
February 8, 2018
Record last verified: 2018-02