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. 2019 Nov 21;19(1):430.
doi: 10.1186/s12884-019-2575-1.

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

V Flenady  1 , G Gardener  2   3 , F M Boyle  2   4 , E Callander  2   5 , M Coory  2 , C East  2   6   7 , D Ellwood  2   5   8 , A Gordon  2   9 , K M Groom  10 , P F Middleton  2   11 , J E Norman  12 , K A Warrilow  2 , M Weller  2 , A M Wojcieszek  2 , C Crowther  10 ; IMPACT Clinical Trials Network for Mothers’ and Babies’ Health
Affiliations

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

V Flenady et al. BMC Pregnancy Childbirth. .

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.

Keywords: Best practice; Decreased fetal movements; Maternity care; Mobile phone application; Stillbirth.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
My Baby’s Movement application. Display of MBM app opening page
Fig. 2
Fig. 2
My Baby’s Movements stepped-wedge design. Stepped-wedged cluster design
Fig. 3
Fig. 3
Care pathway for women presenting with decreased fetal movements from 28 weeks’ gestation. Clinical care management algorithm for women presenting with decreased fetal movements
See this image and copyright information in PMC

References

    1. Heazell AEP, Siassakos D, Blencowe H, et al. Stillbirths: economic and psychosocial consequences. The Lancet. 2016;387(10018):604–616. doi: 10.1016/S0140-6736(15)00836-3. - DOI - PubMed
    1. Lawn JE, Blencowe H, Waiswa P, et al. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet. 2016;387(10018):587–603. doi: 10.1016/S0140-6736(15)00837-5. - DOI - PubMed
    1. Flenady V, Wojcieszek AM, Middleton P, et al. Stillbirths: recall to action in high-income countries. Lancet. 2016;387(10019):691–702. doi: 10.1016/S0140-6736(15)01020-X. - DOI - PubMed
    1. Australian Institute of Health and Welfare . Australia’s mothers and babies 2016. Canberra: AIHW; 2018.
    1. Australian Bureau of Statistics . Causes of death, Australia, 2017. Canberra: Australian Bureau of Statistics; 2018.

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