Background In 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.
This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial.
Methods We describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised 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. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation.
Ethics and dissemination Ethical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM.
Trial registration number www.clinicaltrials.gov NCT01777022.
Version Protocol Version 4.2, 3 February 2017.
- reduced fetal movements
- perinatal mortality
- neonatal death
- fetal growth restriction
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Contributors AEPH, CJW, SJES, CJC, SCB, MRD, SW and JEN were involved in developing the trial design. AEPH, CJW, SJES, AR and JEN were involved in drafting and revision of the article. CJW and AR were involved in drafting the statistical aspects of the protocol. JS provided feedback on behalf of a stakeholder organisation. AEPH, CJW, SJES, CJC, SCB, JFF, MG, AH, FMM, EM, AR, MRD, JS, SW and JEN were involved in preparing the overall study design. AEPH, JEN and MRD prepared education videos for online training. AEPH, SJES, SJS, MG, AH, FMM and JEN facilitated recruitment of sites. AEPH, CJW, SJES, CJC, SCB, JFF, MG, AH, FMM, EM, AR, MRD, JS, SW and JEN will be involved in the collection, management, analysis and interpretation of data, and final writing of the trial report.
Funding The AFFIRM study is investigator initiated and funded by Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's and Sands, the Stillbirth and Neonatal Death Charity. CJW was supported in this work by NHS Lothian via the Edinburgh Clinical Trials Unit. AEPH is supported by a Clinician Scientist 801 fellowship from the National Institute for Health Research (NIHR; CS-2013-009). This protocol presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Ethics approval Scotland A REC: 13/SS/0001.
Provenance and peer review Not commissioned; externally peer reviewed.
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