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

Pregnancy Clinical Trial

— AFFIRM  

Official title:

Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777022
• Other study ID #: AFFIRM
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: February 7, 2018
• Start date: January 1, 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2018
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430830
• Est. completion date: September 30, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Decreased Fetal Movements Affecting Care of Mother
• Pregnancy
• Stillbirth

Intervention

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

Locations

Country	Name	City	State
Ireland	National Maternity Hospital	Dublin
Ireland	Rotunda Hospital	Dublin
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	Birmingham Women's Hospital	Birmingham	West Midlands
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	St. Richards Hospital	Chichester	West Sussex
United Kingdom	NHS Dumfries and Galloway	Dumfries
United Kingdom	NHS Tayside	Dundee
United Kingdom	NHS Lothian	Edinburgh	Lothian
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	Leeds Teaching Hospital NHS Trust	Leeds	Yorkshire
United Kingdom	St Georges Hospital	London
United Kingdom	Saint Mary's hospital	Manchester	Lancashire
United Kingdom	NHS Borders	Melrose
United Kingdom	Royal Gwent Hospital	Newport	Gwent
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston
United Kingdom	Betsi Cadwaladr University Heath board (Glan Clwyd)	Rhyl
United Kingdom	Stepping Hill Hospital	Stockport	Cheshire
United Kingdom	Royal Albert Edward Infirmary, Wigan	Wigan
United Kingdom	NHS Lanarkshire	Wishaw
United Kingdom	Worthing Hospital	Worthing	West Sussex
United Kingdom	Betsi Cadwaladr University Heath board (Wrexham Maelor)	Wrexham

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of package of care to pregnant women and their health care providers		36 Months
Primary	Rates of stillbirth		36 months
Secondary	Rates of caesarean section		36 months
Secondary	Rates of induction of labour		36 Months
Secondary	Rates of admission to the neonatal intensive care unit		36 Months
Secondary	Proportion of women with fetal growth restriction		36 Months