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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\u2019s 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods\/design<\/jats:title><jats:p>This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3\u20135 hospitals at four-monthly intervals over 3\u2009years.<\/jats:p><jats:p>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\u2009weeks\u2019 gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women\u2019s and clinicians\u2019 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?ACTRN=12614000291684\">ACTRN12614000291684<\/jats:ext-link>. Registered 19 March 2014.<\/jats:p><\/jats:sec><jats:sec><jats:title>Version<\/jats:title><jats:p>Protocol Version 6.1, February 2018.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12884-019-2575-1","type":"journal-article","created":{"date-parts":[[2019,11,21]],"date-time":"2019-11-21T15:03:36Z","timestamp":1574348616000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["My Baby\u2019s Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol"],"prefix":"10.1186","volume":"19","author":[{"name":"on behalf of the IMPACT Clinical Trials Network for Mothers\u2019 and Babies\u2019 Health","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8114-7677","authenticated-orcid":false,"given":"V.","family":"Flenady","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Gardener","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. 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Human Research Ethics Committee (EC00332) (MML HREC) in 2015. Further jurisdictional ethics approval was obtained from seven participating HRECs across Australia and New Zealand. The participating HREC offices include the ACT Health Human Research Ethics Committee, Northern Sydney Local Health District (NSLHD) Human Research Ethics Committee (HREC), Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC), The Central Health and Disability Ethics Committee (NZ), WCHN Human Research Ethics Committee, Melbourne Health Human Research Ethics Committee (HREC) and the Mercy Health Human Research Ethics Committee. Governance clearance was obtained from the following 26 sites involved in the trial; Gold Coast University Hospital, Logan Hospital, Ipswich Hospital, Mater Mother\u2019s Hospital, Royal Brisbane and Women\u2019s Hospital, Townsville Hospital, Sunshine Coast University Hospital, Cairns Base Hospital, Nepean Hospital, Liverpool Hospital, Royal Prince Alfred Hospital, Royal Hospital for Women, Royal North Shore Hospital, Monash Medical Centre, Dandenong Hospital, Casey Hospital, Sunshine Hospital, Royal Women\u2019s Hospital Melbourne, Mercy Hospital for Women, Northern Hospital, Auckland Hospital, Christchurch Hospital, Middlemore Hospital, Royal Darwin Hospital, Women\u2019s and Children\u2019s Hospital and Canberra Hospital. Amendments to the protocol and corresponding study documents will be provided for ethical and governance review prior to change. The control period of the study commenced on the 8th of August 2016. Recruitment for the intervention period began in November 2018, within the first cluster, and is due for completion in May 2019. A waiver of consent was obtained for use of the routinely collected data, which was approved by all corresponding ethics committees. The waiver of consent was obtained for all women birthing in the hospitals within the trial regardless of age. As such the need for parental consent has been waivered. Young women (<\u200916\u2009years of age) receiving care at their elected hospital are to be provided the same care as others and as such may receive information on fetal movement monitoring and the MBM app as part of routine care. Inclusion into the trial for young women was discussed with the Mater Misericordiae Ltd. Human Research Ethics sub-committee. It was determined by the sub-committee that the Gillick competence in managing own health care was considered to apply to participation in this study. The position thereby being that respect for the autonomy of the young person in this study mirrored that of the health care situation. All committees approved the manner in which women consent to the MBM app by first downloading and accessing the app to access the consent page. Upon first logging in women will be provided with information on the study and notified that by entering their study ID and accessing the app they are consenting to the study. During the intervention period women will be offered the MBM app from their health care provider as part of routine care. Written consent was obtained for Survey 1a and 1b. Ethics for the trial remains up to date and is due to expire in December 2021.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"430"}}