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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current treatment | No Intervention | Current education and management protocols will be followed | |
| A package of interventions | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A package of interventions | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of stillbirth | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of caesarean section | 36 months | |
| Rates of induction of labour | 36 Months | |
| Rates of admission to the neonatal intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of package of care to pregnant women and their health care providers | 36 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane E Norman, MD | University of Edinburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Maternity Hospital | Dublin | Ireland | ||||
| Rotunda Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35317772 | Derived | Camacho EM, Whyte S, Stock SJ, Weir CJ, Norman JE, Heazell AEP. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a trial-based and model-based cost-effectiveness analysis from a stepped wedge, cluster-randomised trial. BMC Pregnancy Childbirth. 2022 Mar 22;22(1):235. doi: 10.1186/s12884-022-04563-9. | |
| 30269876 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2017 | Nov 7, 2017 |
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|
| 36 Months |
| Proportion of women with fetal growth restriction | 36 Months |
| Dublin |
| Ireland |
| Stepping Hill Hospital | Stockport | Cheshire | SK2 7JE | United Kingdom |
| Royal Gwent Hospital | Newport | Gwent | NP20 2UB | United Kingdom |
| Saint Mary's hospital | Manchester | Lancashire | M13 9WL | United Kingdom |
| NHS Lothian | Edinburgh | Lothian | EH54 | United Kingdom |
| Birmingham Women's Hospital | Birmingham | West Midlands | United Kingdom |
| St. Richards Hospital | Chichester | West Sussex | PO19 6SE | United Kingdom |
| Worthing Hospital | Worthing | West Sussex | United Kingdom |
| Leeds Teaching Hospital NHS Trust | Leeds | Yorkshire | United Kingdom |
| NHS Grampian | Aberdeen | United Kingdom |
| Neville Hall hospital | Abergavenny | United Kingdom |
| Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital) | Bangor | United Kingdom |
| Royal Jubilee Hospital | Belfast | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | United Kingdom |
| NHS Dumfries and Galloway | Dumfries | United Kingdom |
| NHS Tayside | Dundee | United Kingdom |
| NHS Greater Glasgow | Glasgow | United Kingdom |
| NHS Highland | Inverness | United Kingdom |
| NHS Ayrshire and Arran | Kilmarnock | United Kingdom |
| NHS Fife | Kirkcaldy | United Kingdom |
| NHS Forth Valley | Larbert | United Kingdom |
| St Georges Hospital | London | United Kingdom |
| NHS Borders | Melrose | United Kingdom |
| Lancashire Teaching Hospitals NHS Foundation Trust | Preston | United Kingdom |
| Betsi Cadwaladr University Heath board (Glan Clwyd) | Rhyl | United Kingdom |
| Royal Albert Edward Infirmary, Wigan | Wigan | United Kingdom |
| NHS Lanarkshire | Wishaw | United Kingdom |
| Betsi Cadwaladr University Heath board (Wrexham Maelor) | Wrexham | United Kingdom |
| Norman JE, Heazell AEP, Rodriguez A, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Froen JF, Geary M, Breathnach F, Hunter A, McAuliffe FM, Higgins MF, Murdoch E, Ross-Davie M, Scott J, Whyte S; AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018 Nov 3;392(10158):1629-1638. doi: 10.1016/S0140-6736(18)31543-5. Epub 2018 Sep 27. |
| 28801392 | Derived | Heazell AEP, Weir CJ, Stock SJE, Calderwood CJ, Burley SC, Froen JF, Geary M, Hunter A, McAuliffe FM, Murdoch E, Rodriguez A, Ross-Davie M, Scott J, Whyte S, Norman JE. Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM). BMJ Open. 2017 Aug 11;7(8):e014813. doi: 10.1136/bmjopen-2016-014813. |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 27, 2017 | Nov 7, 2017 | Prot_001.pdf |
| ID | Term |
|---|---|
| D050497 | Stillbirth |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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