Trial Complete



can promoting Awareness of Fetal movements and Focusing on Interventions Reduce fetal Mortality?


Principal Investigator – Prof. Fionnuala Breathnach

Rates of stillbirth in Scotland and Ireland remain high. 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 indication both of placental insufficiency and subsequent stillbirth.

The Affirm study will test the hypothesis that the rates of stillbirth will be reduced through the 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.

We 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 detailed routinely collected maternity data, allowing us to robustly test our hypothesis. In addition a nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify barriers to implementation.


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