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

Abstract

Summary Background In 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). Methods We 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. Findings Between 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). Interpretation There 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. Funding Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

Incidence and characteristics of pregnancy‐related death across ten low‐ and middle‐income geographical regions: secondary analysis of a cluster randomised controlled trial

“…This is a secondary analysis of a pragmatic, stepped-wedge cluster randomised controlled trial of the introduction of the Community Blood Pressure Monitoring in Rural Africa: Detection of Underlying Pre-Eclampsia (CRADLE) intervention into routine maternity care in ten regions across Zimbabwe, Zambia, Sierra Leone, Malawi, Ethiopia, Uganda, Haiti and India over 20 months, from 1 April 2016 to 30 November 2017 (International Standard Randomised Controlled Trial Number, ISCRTN: 41244132). 7,8 The CRADLE intervention consisted of the CRADLE Vital Sign Alert, 7,9 a validated device that accurately measures blood pressure (BP) and heart rate and calculates the shock index, displaying the results on a traffic light early warning system, and a simple education package on how to use the device and respond to abnormal vital signs. 10,11 This intervention was compared with routine maternity care using local management guidelines.…”

Do different patient populations need different early warning scores? The performance of nine different early warning scores used on acutely ill patients admitted to a low-resource hospital in sub-Saharan Africa

“…The READS computer system has been used at Kitovu to collect vital signs at the bedside since 2016, and for this study an electrocardiograph was used to assess heart rate, a computer application to accurately determine respiratory rate measured over 60 seconds, and a well-validated blood pressure machine to record blood pressure. [20][21][22] Since our patients were younger than most patient populations in the developed world, it is not surprising that adding age weighting to MEWS did not improve its performance since the weightings for age would have applied to so few patients. 4 The mean temperatures and systolic blood pressures of patients who lived and died were identical; changes in temperature may be intermittent and change in blood pressure may be a late sign of deterioration.…”

Cardiometabolic Risk Factors in Pregnancy and Implications for Long-Term Health: Identifying the Research Priorities for Low-Resource Settings

“…Feasibility studies have shown high levels of acceptability by Community Health Workers (CHWs) in Nigeria, Mozambique, Zimbabwe, Ethiopia and India (18,19). A large stepped-wedge cluster-randomized controlled trial across 10 LMICs was; however, unable to demonstrate impact on the primary composite outcomes of maternal mortality and morbidity (20). This may be due, in part, to insufficient power and sample size, and significant variations between clusters (20).…”

“…A large stepped-wedge cluster-randomized controlled trial across 10 LMICs was; however, unable to demonstrate impact on the primary composite outcomes of maternal mortality and morbidity (20). This may be due, in part, to insufficient power and sample size, and significant variations between clusters (20). Low cost urinalysis devices for proteinuria detection have also been developed and piloted (21)(22)(23), although evidence of impact on clinical endpoints is lacking.…”