Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
NCT ID: NCT01777022
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
430830 participants
INTERVENTIONAL
2014-01-01
2017-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Current treatment
Current education and management protocols will be followed
No interventions assigned to this group
A package of 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
A package of 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
Interventions
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A package of 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
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Inclusion Criteria
Exclusion Criteria
16 Years
60 Years
FEMALE
Yes
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Jane E Norman, MD
Role: STUDY_CHAIR
University of Edinburgh
Locations
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National Maternity Hospital
Dublin, , Ireland
Rotunda Hospital
Dublin, , Ireland
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom
Royal Gwent Hospital
Newport, Gwent, United Kingdom
Saint Mary's hospital
Manchester, Lancashire, United Kingdom
NHS Lothian
Edinburgh, Lothian, United Kingdom
Birmingham Women's Hospital
Birmingham, West Midlands, United Kingdom
St. Richards Hospital
Chichester, West Sussex, 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
Countries
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References
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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.
Norman 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.
Heazell 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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AFFIRM
Identifier Type: -
Identifier Source: org_study_id
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