Pregnancy Clinical Trial
Official title:
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).
n/a
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