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

University of Edinburgh

Status: Completed

Conditions: Decreased Fetal Movements Affecting Care of Mother; Stillbirth; Pregnancy

Treatments: Other: A package of interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT01777022

AFFIRM

Details and patient eligibility

About

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).

Enrollment: 430,830 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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430,830 participants in 2 patient groups

Current treatment

No Intervention group

Description:

Current education and management protocols will be followed

A package of interventions

Other group

Description:

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

Treatment:

Other: A package of interventions