Abstract

BackgroundQuality of care during the intrapartum and immediate postnatal period for maternal and newborn health remains a major challenge due to the multiple health system bottlenecks in low-income countries. Reports of complex interventions that have been effective in reducing maternal and newborn mortality in these settings are usually limited in description, which inhibits learning and replication. We present a detailed account of the Preterm Birth Initiative (PTBi) implementation process, experiences and lessons learnt to inform scale-up and replication.MethodsUsing the TiDieR framework, we detail how the PTBi implemented an integrated package of interventions through a pair-matched cluster randomized control trial in 20 health facilities in Migori County, Kenya, and the Busoga region in east central Uganda from 2016 to 2019. The package aimed to improve quality of care during the intrapartum and immediate postnatal period with a focus on preterm birth. The package included data strengthening (DS) and introduction of a modified WHO Safe Childbirth Checklist (mSCC), simulation-based training and mentoring (PRONTO), and a Quality Improvement (QI) Collaborative.ResultsIn 2016, DS and mSCC were introduced to improve existing data processes and increase the quality of data for measures needed to evaluate study impact. PRONTO and QI interventions were then rolled out sequentially. While package components were implemented with fidelity, some implementation processes required contextual adaptation to allow alignment with national priorities and guidelines, and flexibility to optimize uptake.ConclusionLessons learned included the importance of synergy between interventions, the need for local leadership engagement, and the value of strengthening local systems and resources. Adaptations of individual elements of the package to suit the local context were important for effective implementation, and the TIDieR framework provides the guidance needed in detailed description to replicate such a complex intervention in other settings. Detailed documentation of the implementation process of a complex intervention with mutually synergistic components can help contextualize trial results and potential for scale-up. The trial is registered at ClinicalTrials.govNCT03112018, registered December 2016, posted April 2017.

Highlights

  • Quality of care during the intrapartum and immediate postnatal period for maternal and newborn health remains a major challenge due to the multiple health system bottlenecks in low-income countries

  • Results from the Preterm Birth Initiative (PTBi) cluster randomized control trial (CRCT) showed a significant reduction of fresh stillbirth and mortality among eligible infants in a lowresource setting, and the details for replicability are a critical and complementary part of the study findings

  • This paper provides a detailed account of a complex intervention, which is important to inform decision-makers in low-resource settings about reproducibility and scale-up

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Summary

Introduction

Quality of care during the intrapartum and immediate postnatal period for maternal and newborn health remains a major challenge due to the multiple health system bottlenecks in low-income countries. An estimated three quarters of preterm neonatal deaths could be averted by implementing low-cost evidence-based interventions at the time of birth, including essential newborn care, provision of antenatal corticosteroids to eligible mothers with preterm labor, Kangaroo Mother Care (KMC), support for breastfeeding, and appropriate administration of antibiotics for newborn infections [5, 6]. Another one million preterm stillbirths could be averted each year by improved intrapartum care [7]. Addressing the QoC gap is critical for achieving the ambitious targets set by the Sustainable Development Goals [4]

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