Abstract

BackgroundInsufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period.MethodsThis is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention.DiscussionThere is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions.Trial registrationPan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

Highlights

  • Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3

  • Almost 300,000 women die during pregnancy and childbirth annually [3]

  • The importance to address hypoxic-ischaemic insults causing long-term disabilities or perinatal death is increasingly highlighted [5]. This period provides an opportunity to prevent 800,000 malnutrition-related child deaths annually by initiating breastfeeding [6]. It is considered a central hub for referral and communication along the continuum of care linking antenatal, postnatal and child health care [7]

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Summary

Introduction

Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. Evidence-based care during the intrapartum period, from the onset of labour to the expulsion of the placenta, carries the greatest lifesaving potential [4]. The importance to address hypoxic-ischaemic insults causing long-term disabilities or perinatal death is increasingly highlighted [5]. This period provides an opportunity to prevent 800,000 malnutrition-related child deaths annually by initiating breastfeeding [6]. It is considered a central hub for referral and communication along the continuum of care linking antenatal, postnatal and child health care [7]

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