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Full title: My Baby’s Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths
  • +17
  • Vicki Flenady,
  • Glen Gardener,
  • David Ellwood,
  • Michael Coory,
  • Megan Weller,
  • Kara Warrilow,
  • Philippa Middleton,
  • Aleena Wojcieszek,
  • Katie Groom,
  • Fran Boyle,
  • Christine East,
  • Harriet Lawford,
  • Emily Callander,
  • Joanne Said ,
  • Susan Walker,
  • Kassam Mahomed,
  • Christine Andrews,
  • Adrienne Gordon,
  • Jane Norman ,
  • Caroline A. Crowther
Vicki Flenady
Mater Research Institute, University of Queensland
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Glen Gardener
Mater Research Institute, University of Queensland, Centre of Research Excellence in Stillbirth
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David Ellwood
Griffith University
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Michael Coory
Mater Research Institute, University of Queensland
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Megan Weller
Mater Research Institute, University of Queensland
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Kara Warrilow
Mater Research Institute, University of Queensland
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Philippa Middleton
SAHMRI
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Aleena Wojcieszek
Mater Research Institute, University of Queensland
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Katie Groom
University of Auckland
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Fran Boyle
University of Queensland
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Christine East
La Trobe University Judith Lumley Centre
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Harriet Lawford
Mater Research Institute, University of Queensland
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Emily Callander
Monash University
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Joanne Said
Sunshine Hospital, Melbourne, St Albans VIC 3021
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Susan Walker
University of Melbourne
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Kassam Mahomed
Ipswich Hospital
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Christine Andrews
Mater Research Institute, University of Queensland
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Adrienne Gordon
Royal Prince Alfred Hospital
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Jane Norman
University of Bristol Faculty of Health Sciences
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Caroline A. Crowther
University of Auckland
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Abstract

Objective The My Baby’s Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (MBM intervention). Design Stepped-wedge cluster-randomised controlled trial. Setting Twenty-seven maternity hospitals in Australia and New Zealand. Population Women with a singleton pregnancy without major fetal anomaly ≥28 weeks’ gestation from August 2016-May 2019. Methods The MBM intervention was implemented at randomly assigned time points with sequential introduction into 8 clusters of 3-5 hospitals at four-monthly intervals. The stillbirth rate was compared in the control and intervention periods. Generalised linear mixed models controlled for calendar time, clustering, and hospital effects. Outcome Measures Stillbirth at ≥28 weeks’ gestation. Results There were 304,853 births with 290,219 meeting inclusion criteria: 150,079 in control and 140,140 in intervention periods. The stillbirth rate during the intervention was lower than the control period (2.2/1000 births versus 2.4, odds ratio [OR] 0.91, 95% Confidence Intervals [CI] 0.78-1.06, p=0.22). The decrease was larger across calendar time with 2.7/1000 in the first 18 months versus 2.0/1000 in the last 18 months (OR 0.74; 95% CI 0.63-0.86; p≤0.01). Following adjustment, stillbirth rates between the control and intervention periods were not significantly different: (aOR 1.18, 95% CI 0.93-1.50; p=0.18). No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. Conclusion The MBM intervention did not reduce stillbirths beyond the downward trend over time, suggesting hospitals may have implemented best practice in DFM management outside their randomisation schedule. The role of interventions for raising awareness of DFM remains unclear

Peer review status:IN REVISION

10 Mar 2021Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
16 Mar 2021Assigned to Editor
16 Mar 2021Submission Checks Completed
29 Mar 2021Reviewer(s) Assigned
23 Apr 2021Review(s) Completed, Editorial Evaluation Pending
04 May 2021Editorial Decision: Revise Major