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

This study is not yet open for participant recruitment.
Verified January 2013 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01777022
First received: January 15, 2013
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention
Decreased Fetal Movements Affecting Care of Mother
Pregnancy
Stillbirth
Other: A package of interventions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Rates of stillbirth [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • rates of caesarean section [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Rates of induction of labour [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Rates of admission to the neonatal intensive care unit [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Proportion of women with fetal growth restriction [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Acceptability of package of care to pregnant women and their health care providers [ Time Frame: 36 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110000
Study Start Date: April 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777022

Contacts
Contact: Jane E Norman, MD jane.norman@ed.ac.uk
Contact: Sonia Whyte, MPH +44 131 242 2693 sonia.whyte@ed.ac.uk

Locations
United Kingdom
NHS Lothian Not yet recruiting
Edinburgh, Lothian, United Kingdom, EH54
Contact: Jane E Norman, MD       Jane.norman@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Study Chair: Jane E Norman, MD University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01777022     History of Changes
Other Study ID Numbers: AFFIRM
Study First Received: January 15, 2013
Last Updated: January 25, 2013
Health Authority: United Kingdom: Department of Health
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Education, Stillbirth, Prevention, Management

ClinicalTrials.gov processed this record on April 23, 2014