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

• ClinicalTrials.gov Identifier: NCT01777022
• Recruitment Status: Completed
• First Posted: January 28, 2013
• Last Update Posted: February 8, 2018
• Sponsor: University of Edinburgh
• Collaborator: NHS Lothian
• Information provided by (Responsible Party): University of Edinburgh

Study Description

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

• 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

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

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

• 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

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

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

Norman JE, Heazell AEP, Rodriguez A, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Frøen 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.

• 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