SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania.

BACKGROUND: The 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. METHODS: The 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. DISCUSSION: Previous 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 REGISTRATION: Name of Trial Registry: ISRCTN Registry. TRIAL REGISTRATION NUMBER: ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.

Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting.

OBJECTIVE: To compare the frequency of abnormal fetal heart rate (FHR) detection between continuous Doppler and intermittent fetoscope monitoring. METHOD: A randomized controlled open-label trial was conducted between February 1, 2016, and January 31, 2017, at Haydom Lutheran hospital, Tanzania. Women in active labor with singleton pregnancies and normal FHR at admission were randomly allocated in a 1:1 ratio to receive either continuous or intermittent FHR monitoring. The primary outcome was abnormal FHR detection. RESULTS: 2652 women were enrolled; 1340 received continuous monitoring and 1312 received intermittent monitoring. Continuous FHR monitoring detected abnormal FHR in 108 (8.1%) participants versus 40 (3.0%) participants in the intermittent monitoring group (risk ratio [RR] 2.64, 95% confidence interval [CI] 1.8-3.7; P<0.001). The increased detection rate in the continuous versus intermittent monitoring group was associated with an increase in rate of subsequent intrauterine resuscitations (89 [6.6%] vs 42 [3.2%]; RR 2.07, 95% CI 1.4-2.9; P<0.001). In total, 92 (3.5%) infants had adverse perinatal outcomes, with no significant differences between groups. CONCLUSION: Continuous FHR monitoring increased identification of abnormal FHR and subsequent intrauterine resuscitations. ClinicalTrials.gov: NCT02790814.