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

Nicola Vousden,Muchabayiwa Francis Gidiri,Elodie Lawley,Jane Sandall,Lucy C Chappell,Shivaprasad S Goudar ,Paul Seed ,Andrew Shennan

doi:10.1016/s2214-109x(18)30526-6

Nicola Vousden, Muchabayiwa Francis Gidiri + Show 6 more

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https://doi.org/10.1016/s2214-109x(18)30526-6

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Abstract

SummaryBackgroundIn 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132.FindingsBetween April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86–0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73–2·06; p=0·45).InterpretationThere was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.FundingNewton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

Highlights

Maternal mortality remains a challenge worldwide, especially in low-resource settings, where in 2015, an estimated 303 000 women died from complications of pregnancy and childbirth.[1]
Vital sign measurement is the first step in recognising women at risk of deterioration and, in initiating treatments that can prevent potentially catastrophic maternal and perinatal compli cations.[5]
We identified eight studies, which examine the predictive capacity of early warning systems in pregnancy

Summary

Introduction

Maternal mortality remains a challenge worldwide, especially in low-resource settings, where in 2015, an estimated 303 000 women died from complications of pregnancy and childbirth.[1]. Vital sign measurement is the first step in recognising women at risk of deterioration ( from hyper tension, obstetric haemorrhage, and sepsis) and, in initiating treatments that can prevent potentially catastrophic maternal and perinatal compli cations.[5] Early warning systems allow for tracking of vital signs to alert health-care providers to abnorm alities and allow earlier action They are widely used in high-income settings.[6] Several studies have found early warning sys tems to be beneficial in predicting maternal morbidity and mortality, but these studies are generally small and retrospective.[7,8,9,10,11,12,13] Only one prospective, non-randomised www.thelancet.com/lancetgh Vol 7 March 2019

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