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

Not Applicable

Completed

• Conditions: Pregnancy; Decreased Fetal Movements Affecting Care of Mother; Stillbirth
• Interventions: Other: A package of interventions

• Registration Number: NCT01777022
• Lead Sponsor: University of Edinburgh

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Study Start: 2014-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-09-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 430830

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A package of interventions	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

Primary Outcome Measures

Name	Time	Method
Rates of stillbirth	36 months

Secondary Outcome Measures

Name	Time	Method
Rates of induction of labour	36 Months
Rates of admission to the neonatal intensive care unit	36 Months
Rates of caesarean section	36 months
Proportion of women with fetal growth restriction	36 Months

Trial Locations

Locations (29)

National Maternity Hospital; 🇮🇪 Dublin, Ireland

Stepping Hill Hospital; 🇬🇧 Stockport, Cheshire, United Kingdom

Saint Mary's hospital; 🇬🇧 Manchester, Lancashire, United Kingdom

NHS Grampian; 🇬🇧 Aberdeen, United Kingdom

NHS Greater Glasgow; 🇬🇧 Glasgow, United Kingdom

NHS Forth Valley; 🇬🇧 Larbert, United Kingdom

NHS Ayrshire and Arran; 🇬🇧 Kilmarnock, United Kingdom

NHS Fife; 🇬🇧 Kirkcaldy, United Kingdom

NHS Borders; 🇬🇧 Melrose, United Kingdom

Betsi Cadwaladr University Heath board (Wrexham Maelor); 🇬🇧 Wrexham, United Kingdom

Rotunda Hospital; 🇮🇪 Dublin, Ireland

Worthing Hospital; 🇬🇧 Worthing, West Sussex, United Kingdom

Royal Jubilee Hospital; 🇬🇧 Belfast, United Kingdom

NHS Lothian; 🇬🇧 Edinburgh, Lothian, United Kingdom

Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, Yorkshire, United Kingdom

NHS Lanarkshire; 🇬🇧 Wishaw, United Kingdom

Royal Gwent Hospital; 🇬🇧 Newport, Gwent, United Kingdom

Neville Hall hospital; 🇬🇧 Abergavenny, United Kingdom

Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital); 🇬🇧 Bangor, United Kingdom

St Georges Hospital; 🇬🇧 London, United Kingdom

Royal Albert Edward Infirmary, Wigan; 🇬🇧 Wigan, United Kingdom

St. Richards Hospital; 🇬🇧 Chichester, West Sussex, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, United Kingdom

NHS Dumfries and Galloway; 🇬🇧 Dumfries, United Kingdom

NHS Tayside; 🇬🇧 Dundee, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust; 🇬🇧 Preston, United Kingdom

Betsi Cadwaladr University Heath board (Glan Clwyd); 🇬🇧 Rhyl, United Kingdom

Birmingham Women's Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom

NHS Highland; 🇬🇧 Inverness, United Kingdom