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Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: A pragmatic, stepped-wedge, cluster-randomised controlled trial

The Lancet Global Health Feb 21, 2019

Vousden N, et al. - In this pragmatic, stepped-wedge, cluster-randomised controlled trial, researchers ascertained if the implementation of the CRADLE Vital Sign Alert [a semi-automated device that measures blood pressure and heart rate, and calculates shock index] and an education package into community and facility maternity care in low-resource settings could decrease a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy). This trial was performed in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. The primary outcome of 536,223 deliveries occurred in 4067 women between April 1, 2016, and November 30, 2017, with 998 maternal deaths, 2692 cases of eclampsia and 681 hysterectomies. During the trial, the primary outcome was reduced by an absolute 8%, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. With this trial design, unanticipated methodological challenges were encountered, which could provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.
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