Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial. (AFFIRM)
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| ClinicalTrials.gov Identifier: NCT01777022 |
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Recruitment Status :
Completed
First Posted : January 28, 2013
Last Update Posted : February 8, 2018
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Current treatment
Current education and management protocols will be followed
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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
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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 |
- Rates of stillbirth [ Time Frame: 36 months ]
- 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 ]
- Acceptability of package of care to pregnant women and their health care providers [ Time Frame: 36 Months ]
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| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
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
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| Study Chair: | Jane E Norman, MD | University of Edinburgh |
Documents provided by University of Edinburgh:
| 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 |
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Education, Stillbirth, Prevention, Management |
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Stillbirth Fetal Death Pregnancy Complications Death Pathologic Processes |