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Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial.
Lancet 2018; 392(10158):1629-1638Lct

Abstract

BACKGROUND

2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth.

METHODS

This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022.

FINDINGS

37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23).

INTERPRETATION

The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven.

FUNDING

Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

Authors+Show Affiliations

Tommy's Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: jane.norman@ed.ac.uk.Tommy's Maternal and Fetal Health Research Centre, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; St Mary's Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.Centre for Population Health Sciences, Usher Institute of Population Health, Sciences and Informatics, University of Edinburgh, Edinburgh, UK.Centre for Population Health Sciences, Usher Institute of Population Health, Sciences and Informatics, University of Edinburgh, Edinburgh, UK.Tommy's Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.The Scottish Government, Edinburgh, UK.Centre for Population Health Sciences, Usher Institute of Population Health, Sciences and Informatics, University of Edinburgh, Edinburgh, UK.Global Health Cluster, Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.Rotunda Hospital, Dublin, Ireland.Rotunda Hospital, Dublin, Ireland.Centre for Fetal Medicine, Royal Maternity Hospital, Belfast, UK.UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.Department of Neonatology, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.Royal College of Midwives, Edinburgh, UK.Sands, Victoria Charity Centre, London, UK.Tommy's Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30269876

Citation

Norman, Jane E., et al. "Awareness of Fetal Movements and Care Package to Reduce Fetal Mortality (AFFIRM): a Stepped Wedge, Cluster-randomised Trial." Lancet (London, England), vol. 392, no. 10158, 2018, pp. 1629-1638.
Norman JE, Heazell AEP, Rodriguez A, et al. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018;392(10158):1629-1638.
Norman, J. E., Heazell, A. E. P., Rodriguez, A., Weir, C. J., Stock, S. J. E., Calderwood, C. J., ... Whyte, S. (2018). Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet (London, England), 392(10158), pp. 1629-1638. doi:10.1016/S0140-6736(18)31543-5.
Norman JE, et al. Awareness of Fetal Movements and Care Package to Reduce Fetal Mortality (AFFIRM): a Stepped Wedge, Cluster-randomised Trial. Lancet. 2018 11 3;392(10158):1629-1638. PubMed PMID: 30269876.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. AU - Norman,Jane E, AU - Heazell,Alexander E P, AU - Rodriguez,Aryelly, AU - Weir,Christopher J, AU - Stock,Sarah J E, AU - Calderwood,Catherine J, AU - Cunningham Burley,Sarah, AU - Frøen,J Frederik, AU - Geary,Michael, AU - Breathnach,Fionnuala, AU - Hunter,Alyson, AU - McAuliffe,Fionnuala M, AU - Higgins,Mary F, AU - Murdoch,Edile, AU - Ross-Davie,Mary, AU - Scott,Janet, AU - Whyte,Sonia, AU - ,, Y1 - 2018/09/27/ PY - 2018/03/28/received PY - 2018/06/12/revised PY - 2018/06/28/accepted PY - 2018/10/3/pubmed PY - 2019/2/7/medline PY - 2018/10/2/entrez SP - 1629 EP - 1638 JF - Lancet (London, England) JO - Lancet VL - 392 IS - 10158 N2 - BACKGROUND: 2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. METHODS: This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022. FINDINGS: 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23). INTERPRETATION: The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. FUNDING: Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/30269876/Awareness_of_fetal_movements_and_care_package_to_reduce_fetal_mortality__AFFIRM_:_a_stepped_wedge_cluster_randomised_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(18)31543-5 DB - PRIME DP - Unbound Medicine ER -