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      My Baby’s Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol

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          Abstract

          Background

          Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby’s Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates.

          Methods/design

          This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3–5 hospitals at four-monthly intervals over 3 years.

          The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks’ gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women’s and clinicians’ knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models.

          Discussion

          Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app.

          Trial registration

          ACTRN12614000291684. Registered 19 March 2014.

          Version

          Protocol Version 6.1, February 2018.

          Related collections

          Most cited references 34

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          Stillbirths: ending preventable deaths by 2030.

          Efforts to achieve the new worldwide goals for maternal and child survival will also prevent stillbirth and improve health and developmental outcomes. However, the number of annual stillbirths remains unchanged since 2011 and is unacceptably high: an estimated 2.6 million in 2015. Failure to consistently include global targets or indicators for stillbirth in post-2015 initiatives shows that stillbirths are hidden in the worldwide agenda. This Series paper summarises findings from previous papers in this Series, presents new analyses, and proposes specific criteria for successful integration of stillbirths into post-2015 initiatives for women's and children's health. Five priority areas to change the stillbirth trend include intentional leadership; increased voice, especially of women; implementation of integrated interventions with commensurate investment; indicators to measure effect of interventions and especially to monitor progress; and investigation into crucial knowledge gaps. The post-2015 agenda represents opportunities for all stakeholders to act together to end all preventable deaths, including stillbirths.
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            Stillbirths: why they matter.

            In this first paper of The Lancet's Stillbirths Series we explore the present status of stillbirths in the world-from global health policy to a survey of community perceptions in 135 countries. Our findings highlight the need for a strong call for action. In times of global focus on motherhood, the mother's own aspiration of a liveborn baby is not recognised on the world's health agenda. Millions of deaths are not counted; stillbirths are not in the Global Burden of Disease, nor in disability-adjusted life-years lost, and they are not part of the UN Millennium Development Goals. The grief of mothers might be aggravated by social stigma, blame, and marginalisation in regions where most deaths occur. Most stillborn babies are disposed of without any recognition or ritual, such as naming, funeral rites, or the mother holding or dressing the baby. Beliefs in the mother's sins and evil spirits as causes of stillbirth are rife, and stillbirth is widely believed to be a natural selection of babies never meant to live. Stillbirth prevention is closely linked with prevention of maternal and neonatal deaths. Knowledge of causes and feasible solutions for prevention is key to health professionals' priorities, to which this Stillbirths Series paper aims to contribute. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Stillbirths: how can health systems deliver for mothers and babies?

              The causes of stillbirths are inseparable from the causes of maternal and neonatal deaths. This report focuses on prevention of stillbirths by scale-up of care for mothers and babies at the health-system level, with consideration for effects and cost. In countries with high mortality rates, emergency obstetric care has the greatest effect on maternal and neonatal deaths, and on stillbirths. Syphilis detection and treatment is of moderate effect but of lower cost and is highly feasible. Advanced antenatal care, including induction for post-term pregnancies, and detection and management of hypertensive disease, fetal growth restriction, and gestational diabetes, will further reduce mortality, but at higher cost. These interventions are best packaged and provided through linked service delivery methods tailored to suit existing health-care systems. If 99% coverage is reached in 68 priority countries by 2015, up to 1·1 million (45%) third-trimester stillbirths, 201 000 (54%) maternal deaths, and 1·4 million (43%) neonatal deaths could be saved per year at an additional total cost of US$10·9 billion or $2·32 per person, which is in the range of $0·96-2·32 for other ingredients-based intervention packages with only recurrent costs. Copyright © 2011 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                0419 664 956 , stillbirthcre@mater.uq.edu.au
                Journal
                BMC Pregnancy Childbirth
                BMC Pregnancy Childbirth
                BMC Pregnancy and Childbirth
                BioMed Central (London )
                1471-2393
                21 November 2019
                21 November 2019
                2019
                : 19
                Affiliations
                [1 ]ISNI 0000 0000 9320 7537, GRID grid.1003.2, Centre of Research Excellence in Stillbirth, Mater Research Institute, , The University of Queensland, ; Level 3 Aubigny Place Mater Research, South Brisbane QLD, Brisbane, 4101 Australia
                [2 ]Department of Maternal Fetal Medicine, Mater Misericordiae Limited, Brisbane, Australia
                [3 ]ISNI 0000 0000 9320 7537, GRID grid.1003.2, Institute for Social Science Research, , The University of Queensland, ; Brisbane, Australia
                [4 ]ISNI 0000 0004 0437 5432, GRID grid.1022.1, School of Medicine, , Griffith University, ; Gold Coast, Australia
                [5 ]ISNI 0000 0004 1936 7857, GRID grid.1002.3, School of Nursing and Midwifery, , Monash University and Monash Women’s Maternity Services, ; Clayton, Victoria Australia
                [6 ]School of Nursing & Midwifery, La Trobe University, Melbourne, Brazil
                [7 ]ISNI 0000 0004 0625 9072, GRID grid.413154.6, Gold Coast University Hospital, ; Southport, Australia
                [8 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Sydney Medical School, , University of Sydney, ; Sydney, Australia
                [9 ]ISNI 0000 0004 0372 3343, GRID grid.9654.e, Liggins Institute, , University of Auckland, ; Auckland, New Zealand
                [10 ]GRID grid.430453.5, SAHMRI Women and Kids, , South Australian Health and Medical Research Institute, ; Adelaide, Australia
                [11 ]ISNI 0000 0004 1936 7603, GRID grid.5337.2, Faculty of Health Sciences, , University of Bristol, ; Bristol, UK
                Article
                2575
                10.1186/s12884-019-2575-1
                6873438
                31752771
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                Study Protocol
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                © The Author(s) 2019

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