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My Baby’s Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

BJOG. 2021 Sep 23. doi: 10.1111/1471-0528.16944. Online ahead of print.

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/SAMPLE: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks’ gestation from August 2016-May 2019.

METHODS: The MBM intervention was implemented at randomly assigned time points with sequential introduction into 8 groups of 3-5 hospitals at four-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and intervention periods adjusting for calendar time, study population characteristics, and hospital effects.

OUTCOME MEASURES: Stillbirth at ≥28 weeks’ gestation.

RESULTS: There were 304,850 births with 290,105 meeting inclusion criteria: 150,053 in control and 140,052 in intervention periods. The stillbirth rate was lower (although not statistically significantly) during the intervention compared with the control period (2.2 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; p=0.18) The decrease in stillbirth rates was larger across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. 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. Due to low uptake, the role of the intervention remains unclear, though the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, awareness of fetal movements may have reached pregnant women and clinicians prior to implementation of the intervention.

PMID:34555257 | DOI:10.1111/1471-0528.16944

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