Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial. (AFFIRM)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Decreased Fetal Movements Affecting Care of Mother; Pregnancy; Stillbirth	Other: A package of interventions	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	430830 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Actual Study Start Date :	January 1, 2014
Actual Primary Completion Date :	December 31, 2016
Actual Study Completion Date :	September 30, 2017

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Current treatment; Current education and management protocols will be followed
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	Other: 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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Rates of stillbirth [ Time Frame: 36 months ]

Secondary Outcome Measures :

1. Rates of caesarean section [ Time Frame: 36 months ]
2. Rates of induction of labour [ Time Frame: 36 Months ]
3. Rates of admission to the neonatal intensive care unit [ Time Frame: 36 Months ]
4. Proportion of women with fetal growth restriction [ Time Frame: 36 Months ]

Other Outcome Measures:

1. Acceptability of package of care to pregnant women and their health care providers [ Time Frame: 36 Months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Ireland
National Maternity Hospital
Dublin, Ireland
Rotunda Hospital
Dublin, Ireland
United Kingdom
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom, SK2 7JE
Royal Gwent Hospital
Newport, Gwent, United Kingdom, NP20 2UB
Saint Mary's hospital
Manchester, Lancashire, United Kingdom, M13 9WL
NHS Lothian
Edinburgh, Lothian, United Kingdom, EH54
Birmingham Women's Hospital
Birmingham, West Midlands, United Kingdom
St. Richards Hospital
Chichester, West Sussex, United Kingdom, PO19 6SE
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

Sponsors and Collaborators

University of Edinburgh

NHS Lothian

Investigators

Study Chair:	Jane E Norman, MD	University of Edinburgh

  Study Documents (Full-Text)

Documents provided by University of Edinburgh:

Statistical Analysis Plan  [PDF] October 5, 2017

Study Protocol  [PDF] February 27, 2017

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT01777022 History of Changes
Other Study ID Numbers:	AFFIRM
First Posted:	January 28, 2013
Last Update Posted:	February 8, 2018
Last Verified:	February 2018

Keywords provided by University of Edinburgh:

Education, Stillbirth, Prevention, Management

Additional relevant MeSH terms:

Stillbirth; Fetal Death; Pregnancy Complications; Death; Pathologic Processes