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

February 7, 2018 updated by: University of Edinburgh

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • National Maternity Hospital
      • Dublin, Ireland
        • Rotunda Hospital
  • United Kingdom
      • Aberdeen, United Kingdom
        • NHS Grampian
      • Abergavenny, United Kingdom
        • Neville Hall Hospital
      • Bangor, United Kingdom
        • Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital)
      • Belfast, United Kingdom
        • Royal Jubilee Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Dumfries, United Kingdom
        • NHS Dumfries and Galloway
      • Dundee, United Kingdom
        • NHS Tayside
      • Glasgow, United Kingdom
        • NHS Greater Glasgow
      • Inverness, United Kingdom
        • Nhs Highland
      • Kilmarnock, United Kingdom
        • NHS Ayrshire and Arran
      • Kirkcaldy, United Kingdom
        • NHS Fife
      • Larbert, United Kingdom
        • NHS Forth Valley
      • London, United Kingdom
        • St Georges Hospital
      • Melrose, United Kingdom
        • NHS Borders
      • Preston, United Kingdom
        • Lancashire Teaching Hospitals NHS Foundation Trust
      • Rhyl, United Kingdom
        • Betsi Cadwaladr University Heath board (Glan Clwyd)
      • Wigan, United Kingdom
        • Royal Albert Edward Infirmary, Wigan
      • Wishaw, United Kingdom
        • NHS Lanarkshire
      • Wrexham, United Kingdom
        • Betsi Cadwaladr University Heath board (Wrexham Maelor)
    • Cheshire
      • Stockport, Cheshire, United Kingdom, SK2 7JE
        • Stepping Hill Hospital
    • Gwent
      • Newport, Gwent, United Kingdom, NP20 2UB
        • Royal Gwent Hospital
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Saint Mary's Hospital
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH54
        • NHS Lothian
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Birmingham Women's Hospital
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • St. Richards Hospital
      • Worthing, West Sussex, United Kingdom
        • Worthing Hospital
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom
        • Leeds Teaching Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Current treatment
Current education and management protocols will be followed
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rates of stillbirth
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of caesarean section
Time Frame: 36 months
36 months
Rates of induction of labour
Time Frame: 36 Months
36 Months
Rates of admission to the neonatal intensive care unit
Time Frame: 36 Months
36 Months
Proportion of women with fetal growth restriction
Time Frame: 36 Months
36 Months

Other Outcome Measures

Outcome Measure
Time Frame
Acceptability of package of care to pregnant women and their health care providers
Time Frame: 36 Months
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Study Chair: Jane E Norman, MD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFFIRM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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