Clinical trial NCT01777022: Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Official title: Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decreased Fetal Movements Affecting Care of Mother
Pregnancy
Stillbirth
Keywords: Education, Stillbirth, Prevention, Management
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2013-01-28
Enrollment: 430830
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: Inclusion Criteria:

* The study will include all women delivering at one of the maternity units involved in for the duration of the study.

Exclusion Criteria:

* Women delivering in the "washout" period in each unit.

Primary outcomes:
measure: Rates of stillbirth
timeFrame: 36 months
Secondary outcomes:
measure: Rates of caesarean section
timeFrame: 36 months
measure: Rates of induction of labour
timeFrame: 36 Months
measure: Rates of admission to the neonatal intensive care unit
timeFrame: 36 Months
measure: Proportion of women with fetal growth restriction
timeFrame: 36 Months
Other outcomes:
measure: Acceptability of package of care to pregnant women and their health care providers
timeFrame: 36 Months
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital
city: Dublin
country: Ireland
facility: Rotunda Hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: Cheshire
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
state: Gwent
city: Manchester
country: United Kingdom
facility: Saint Mary's hospital
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
state: Lothian
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
state: West Midlands
city: Chichester
country: United Kingdom
facility: St. Richards Hospital
state: West Sussex
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: West Sussex
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
state: Yorkshire
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Abergavenny
country: United Kingdom
facility: Neville Hall hospital
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital)
city: Belfast
country: United Kingdom
facility: Royal Jubilee Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Dumfries
country: United Kingdom
facility: NHS Dumfries and Galloway
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow
city: Inverness
country: United Kingdom
facility: NHS Highland
city: Kilmarnock
country: United Kingdom
facility: NHS Ayrshire and Arran
city: Kirkcaldy
country: United Kingdom
facility: NHS Fife
city: Larbert
country: United Kingdom
facility: NHS Forth Valley
city: London
country: United Kingdom
facility: St Georges Hospital
city: Melrose
country: United Kingdom
facility: NHS Borders
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
city: Rhyl
country: United Kingdom
facility: Betsi Cadwaladr University Heath board (Glan Clwyd)
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary, Wigan
city: Wishaw
country: United Kingdom
facility: NHS Lanarkshire
city: Wrexham
country: United Kingdom
facility: Betsi Cadwaladr University Heath board (Wrexham Maelor)
Study officials:
affiliation: University of Edinburgh
name: Jane E Norman, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.