Abstract
BackgroundStillbirth 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/designThis 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.DiscussionMaternal 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 registrationACTRN12614000291684. Registered 19 March 2014.VersionProtocol Version 6.1, February 2018.
Highlights
DiscussionMaternal perception of decreased fetal movements (DFM) is a marker of an at-risk pregnancy and commonly precedes a stillbirth
Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families
While the trial was not designed to detect a difference in stillbirth rates, no difference was shown in the proportion of women presenting with decreased fetal movements (DFM), induction rates, maternal concern about the baby [38] or maternal fetal attachment [22]
Summary
Stillbirth is a common and devastating outcome with long lasting psychosocial impact for women and families. Many of these deaths are potentially avoidable. Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. Suboptimal awareness by women of the importance of DFM and/or delay in seeking health care with concerns of DFM limits its potential. The delay is related to the lack of appreciation of the importance of FM as a result of inadequate information provided in busy maternity care settings. There is support in the community and in clinical practice of the need to ensure women receive better information and support about DFM during pregnancy. MBM offers a simple, inexpensive resource to reduce the numbers of stillborn babies and families suffering the distressing consequences of such a loss
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