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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777022
First Posted: January 28, 2013
Last Update Posted: November 14, 2017
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.
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
January 15, 2013
January 28, 2013
November 14, 2017
January 13, 2013
December 31, 2016   (Final data collection date for primary outcome measure)
Rates of stillbirth [ Time Frame: 36 months ]
Same as current
Complete list of historical versions of study NCT01777022 on ClinicalTrials.gov Archive Site
  • Rates of caesarean section [ Time Frame: 36 months ]
  • Rates of induction of labour [ Time Frame: 36 Months ]
  • Rates of admission to the neonatal intensive care unit [ Time Frame: 36 Months ]
  • Proportion of women with fetal growth restriction [ Time Frame: 36 Months ]
Same as current
Acceptability of package of care to pregnant women and their health care providers [ Time Frame: 36 Months ]
Same as current
 
Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Decreased Fetal Movements Affecting Care of Mother
  • Pregnancy
  • 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
  • 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
    Intervention: Other: A package of interventions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430830
September 30, 2017
December 31, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
16 Years to 60 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
 
NCT01777022
AFFIRM
Yes
Not Provided
Not Provided
University of Edinburgh
University of Edinburgh
NHS Lothian
Study Chair: Jane E Norman, MD University of Edinburgh
University of Edinburgh
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP