Abstract
BackgroundThe burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival.MethodsThe project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live.Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99.DiscussionPrevious reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope.Trial registrationName of Trial Registry: ISRCTN Registry.Trial registration number: ISRCTN30541755.Date of Registration: 12/10/2020.Type of registration: Prospectively Registered.
Highlights
The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middleincome countries, especially around the time of birth
Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope
There were 2.4 million neonatal deaths in 2019 – approximately 6700 neonatal deaths every day – with about a third of all neonatal deaths occurring within the first day after birth, and close to three-quarters occurring within the first week of life [2]
Summary
The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middleincome countries, especially around the time of birth. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. The low-and-middle income countries (LMICs) contribute significantly (approximately 98%) to global rates of stillbirths andneonatal and maternal mortality. In 2016, Tanzania recorded 20 stillbirths/1000 births and 25 neonatal deaths/1000 live births. Tanzania reported 556 maternal deaths/ 100,000 live births in 2019, translating to 1 in 33 women dying in relation to pregnancy and childbirth [7], mostly due to postpartum haemorrhage (PPH)
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