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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01777022
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777022


Locations
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Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01777022    
Other Study ID Numbers: AFFIRM
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by University of Edinburgh:
Education, Stillbirth, Prevention, Management
Additional relevant MeSH terms:
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Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes