A cluster randomized controlled trial to assess the impact of the 'Caring for Providers to Improve Patient Experience' (CPIPE) intervention in Kenya and Ghana: study protocol.

BACKGROUND: Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the "Caring for Providers to Improve Patient Experience" (CPIPE) intervention, which includes five strategies, targeting provider stress and bias as intermediate factors to improve PCMC and address inequities. METHODS: The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will be assessed among healthcare workers in the study health facilities and among women who give birth in the study health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. DISCUSSION: This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06085105. Protocol version and date: v2-11-07-23.

Women's experiences of maternal near miss: Qualitative findings from Malawi.

OBJECTIVE: This study explored the experiences of women with maternal near miss and their perceptions of the quality of care they received in three facilities in Malawi. METHODS: This study employed a qualitative phenomenological approach. Data were collected using in depth interviews and analysed using thematic content analysis. The data were collected in three hospitals between September and November 2020. The purposively selected participants were 18 women meeting criteria for maternal near miss related to obstetric haemorrhage (6), hypertensive disorders (7), sepsis (2) and ruptured ectopic pregnancy (3). RESULTS: Women's experiences of maternal near miss fell under four broad themes; (a) realisation of the near miss; (b) religious beliefs and interpretation of near miss; (c) social and economic aspects of maternal near miss; and d) perceptions of quality of care. Women's initial emotional responses were fear and anxiety but were soon overshadowed by the fear for their babies' wellbeing. Most women perceived the care they received as timely, adequate, and respectful, yet many women also expressed that their service providers did not provide an opportunity to openly discuss their condition. CONCLUSIONS: The experience of near miss goes beyond the immediate physical discomforts and has psychological, economic, and social consequences for women and their families. Despite women's perception of care as respectful, there are still communication gaps with their service providers. Campaigns to improve the communication between providers and patients and their families in situation of severe morbidity warrant consideration.

A cluster randomized controlled trial to assess the impact of the 'Caring for Providers to Improve Patient Experience' intervention on person-centered maternity care in Kenya and Ghana: Study Protocol.

Background: Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the "Caring for Providers to Improve Patient Experience" (CPIPE) intervention, which includes five strategies for provider behavior change, targeting provider stress and bias as intermediate factors to improve PCMC and to address inequities. Methods: The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will also be assessed first among providers, and then among women who give birth in health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. Discussion: This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health.

Temporary childbirth migration and maternal health care in India.

BACKGROUND: Women in South Asia often return to their natal home during pregnancy, for childbirth, and stay through the postpartum period-potentially impacting access to health care and health outcomes in this important period. However, this phenomenon is understudied (and not even named) in the demographic or health literature, nor do we know how it impacts health. OBJECTIVE: The aim of this study is to measure the magnitude, timing, duration, risk factors and impact on care of this phenomenon, which we name Temporary Childbirth Migration. METHODS: Using data from 9,033 pregnant and postpartum women collected in 2019 in two large states of India (Madhya Pradesh and Bihar) we achieve these aims using descriptive statistics and logistic regression models, combined with qualitative data from community health workers about this practice. RESULTS: We find that about one third of women return to their natal home at some point in pregnancy or postpartum, mostly clustered close to the time of delivery. Younger, primiparous, and non-Hindu women were more likely to return to their natal home. Women reported that they went to their natal home because they believed that they would receive better care; this was born out by our analysis in Bihar, but not Madhya Pradesh, for prenatal care. CONCLUSIONS: Temporary childbirth migration is common, and, contrary to expectations, did not lead to disruptions in care, but rather led to more access to care. CONTRIBUTION: We describe a hitherto un-named, underexplored yet common phenomenon that has implications for health care use and potentially health outcomes.

Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial.

OBJECTIVE: To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation) risk factors for PPH. METHODS: The present study is a secondary analysis of the CHAMPION non-inferiority randomized trial-a two-arm, double-blind, active-controlled study conducted at 23 hospitals in 10 countries, between July 2015 and January 2018. Women with singleton pregnancies, expected to deliver vaginally with cervical dilatation up to 6 cm were eligible. Randomization was stratified by country, with 1:1 assignment. Women in the intervention and control groups received a single intramuscular injection of 100 µg of HSC or 10 IU of oxytocin, respectively. The drugs were administered immediately after birth, and the third stage of labor was managed according to the WHO guidelines. Blood was collected using a plastic drape. For this analysis, we defined a woman as being at risk if she had any one or more of the biologic or pharmacologic risk factor(s). RESULTS: The HSC and oxytocin arms contained 14 770 and 14 768 women, respectively. The risk ratios (RR) for PPH were 1.29 (95% confidence interval [CI] 1.08-1.53) or 1.73 (95% CI 1.51-1.98) for those with only biologic (macrosomia, parity 3 or more, and PPH in the previous pregnancy) or only pharmacologic (induced or augmented) risk factors, respectively, compared with those with neither risk factors. CONCLUSIONS: Findings reinforce previous evidence that macrosomia, high parity, history of PPH, and induction/augmentation are risk factors for PPH. We did not find a difference in effects between HSC and oxytocin for PPH among women who were neither induced nor augmented or among those who were induced or augmented.

Quality improvement collaboratives as part of a quality improvement intervention package for preterm births at sub-national level in East Africa: a multi-method analysis.

BACKGROUND: Quality improvement collaboratives (QIC) are an approach to accelerate the spread and impact of evidence-based interventions across health facilities, which are found to be particularly successful when combined with other interventions such as clinical skills training. We implemented a QIC as part of a quality improvement intervention package designed to improve newborn survival in Kenya and Uganda. We use a multi-method approach to describe how a QIC was used as part of an overall improvement effort and describe specific changes measured and participant perceptions of the QIC. METHODS: We examined QIC-aggregated run charts on three shared indicators related to uptake of evidence-based practices over time and conducted key informant interviews to understand participants' perceptions of quality improvement practice. Run charts were evaluated for change from baseline medians. Interviews were analysed using framework analysis. RESULTS: Run charts for all indicators reflected an increase in evidence-based practices across both countries. In Uganda, pre-QIC median gestational age (GA) recording of 44% improved to 86%, while Kangaroo Mother Care (KMC) initiation went from 51% to 96% and appropriate antenatal corticosteroid (ACS) use increased from 17% to 74%. In Kenya, these indicators went from 82% to 96%, 4% to 74% and 4% to 57%, respectively. Qualitative results indicate that participants appreciated the experience of working with data, and the friendly competition of the QIC was motivating. The participants reported integration of the QIC with other interventions of the package as a benefit. CONCLUSIONS: In a QIC that demonstrated increased evidence-based practices, QIC participants point to data use, friendly competition and package integration as the drivers of success, despite challenges common to these settings such as health worker and resource shortages. TRIAL REGISTRATION NUMBER: NCT03112018.

Adapting the preterm birth phenotyping framework to a low-resource, rural setting and applying it to births from Migori County in western Kenya.

BACKGROUND: Preterm birth is the leading cause of neonatal and under-five mortality worldwide. It is a complex syndrome characterized by numerous etiologic pathways shaped by both maternal and fetal factors. To better understand preterm birth trends, the Global Alliance to Prevent Prematurity and Stillbirth published the preterm birth phenotyping framework in 2012 followed by an application of the model to a global dataset in 2015 by Barros, et al. Our objective was to adapt the preterm birth phenotyping framework to retrospective data from a low-resource, rural setting and then apply the adapted framework to a cohort of women from Migori, Kenya. METHODS: This was a single centre, observational, retrospective chart review of eligible births from November 2015 - March 2017 at Migori County Referral Hospital. Adaptations were made to accommodate limited diagnostic capabilities and data accuracy concerns. Prevalence of the phenotyping conditions were calculated as well as odds of adverse outcomes. RESULTS: Three hundred eighty-seven eligible births were included in our study. The largest phenotype group was none (no phenotype could be identified; 41.1%), followed by extrauterine infection (25.1%), and antepartum stillbirth (16.7%). Extrauterine infections included HIV (75.3%), urinary tract infections (24.7%), malaria (4.1%), syphilis (3.1%), and general infection (3.1%). Severe maternal condition was ranked fourth (15.6%) and included anaemia (69.5%), chronic respiratory distress (22.0%), chronic hypertension prior to pregnancy (5.1%), diabetes (3.4%), epilepsy (3.4%), and sickle cell disease (1.7%). Fetal anaemia cases were the most likely to transfer to the newborn unit (OR 5.1, 95% CI 0.8, 30.9) and fetal anomaly cases were the most likely to result in a pre-discharge mortality (OR 3.9, 95% CI 0.8, 19.2). CONCLUSIONS: Using routine data sources allowed for a retrospective analysis of an existing dataset, requiring less time and fewer resources than a prospective study and demonstrating a feasible approach to preterm phenotyping for use in low-resource settings to inform local prevention strategies.

Preterm birth is a complex syndrome, yet it is the leading cause of death in children worldwide. To help unravel the clinical complexities, preterm birth phenotyping is a framework that considers multiple diagnoses in the mother, helping to evaluate trends in causes of preterm birth in a given region. In our study, we adapted this international phenotyping framework to accommodate a rural, low-resource setting where obstetrical and neonatal technologies were limited, but preterm birth rates were high. We evaluated data from the patient records of a large hospital in Migori, Kenya, in the southwestern region of the country. By lowering the threshold of diagnostic criteria, we were able to apply this framework to our dataset and see that maternal infection and maternal chronic illness appear to be a significant driving forces of preterm birth. Given high rates of HIV and malaria in the region, this is not a surprising finding, but one that can inform antenatal care practices, mainly the need to test and treat for common infections (HIV, malaria, as well as urinary and reproductive tract infections), and to increase the frequency of antenatal care interactions per the World Health Organization recommendations.

Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study.

OBJECTIVE: Data on long-term outcomes of preterm (PT) and low birth weight (LBW) infants in countries with high rates of neonatal mortality and childhood stunting are limited, especially from community settings. The current study sought to explore growth and neurodevelopmental outcomes of PT/LBW infants from a rural community-based setting of Kenya up to 18 months adjusted age. DESIGN: Cross-sectional study. SETTING: Migori County, Kenya. PARTICIPANTS: Three hundred and eighty-two PT/LBW infants (50.2% of those identified as eligible) from a cluster randomised control trial evaluating a package of facility-based intrapartum quality of care interventions for newborn survival consented for follow-up. OUTCOME MEASURES: Caregiver interviews and infant health, growth and neurodevelopmental assessments were completed at 6, 12 or 18 months±2 weeks. Data included sociodemographic information, medical history, growth measurements and neurodevelopmental assessment using the Ten Questions Questionnaire, Malawi Developmental Assessment Tool and Hammersmith Infant Neurological Examination. Analyses were descriptive and univariate regression models. No alterations were made to planned data collection. RESULTS: The final sample included 362 PT/LBW infants, of which 56.6% were moderate to late PT infants and 64.4% were LBW. Fewer than 2% of parents identified their child as currently malnourished, but direct measurement revealed higher proportions of stunting and underweight than in national demographic and health survey reports. Overall, 22.7% of caregivers expressed concern about their child's neurodevelopmental status. Neurodevelopmental delays were identified in 8.6% of infants based on one or more standardised tools, and 1.9% showed neurological findings indicative of cerebral palsy. CONCLUSIONS: Malnutrition and neurodevelopmental delays are common among PT/LBW infants in this setting. Close monitoring and access to early intervention programmes are needed to help these vulnerable infants thrive. TRIAL REGISTRATION NUMBER: NCT03112018.

Utilizing a mixed-methods approach to assess implementation fidelity of a group antenatal care trial in Rwanda.

BACKGROUND: The Preterm Birth Initiative (PTBi)-Rwanda conducted a cluster randomized controlled trial to assess the impact of group antenatal care (group ANC) on preterm birth, using a group ANC approach adapted for the Rwanda setting, and implemented in 18 health centers. Previous research showed high overall fidelity of implementation, but lacked correlation with provider self-assessment and left unanswered questions. This study utilizes a mixed-methods approach to study the fidelity with which the health centers' implementation followed the model specified for group ANC. METHODS: Implementation fidelity was measured using two tools, repeated Model Fidelity Assessments (MFAs) and Activity Reports (ARs) completed by Master Trainers, who visited each health center between 7 and 13 times (9 on average) to provide monitoring and training over 18 months between 2017 and 2019. Each center's MFA item and overall scores were regressed (linear regression) on the time elapsed since the center's start of implementation. The Activity Report (AR) is an open-ended template to record comments on implementation. For the qualitative analysis, the ARs from the times of each center's highest and lowest MFA score were analyzed using thematic analysis. Coding was conducted via Dedoose, with two coders independently reviewing and coding transcripts, followed by joint consensus coding. RESULTS: A total of 160 MFA reports were included in the analysis. There was a significant positive association between elapsed time since a health center started implementation and greater implementation fidelity (as measured by MFA scores). In the qualitative AR analysis, Master Trainers identified key areas to improve fidelity of implementation, including: group ANC scheduling, preparing the room for group ANC sessions, provider capacity to co-facilitate group ANC, and facilitator knowledge and skills regarding group ANC content and process. These results reveal that monitoring visits are an important part of acquisition and fidelity of the "soft skills" required to effectively implement group ANC and provide an understanding of the elements that may have impacted fidelity as described by Master Trainers. CONCLUSIONS: For interventions like Group ANC, where "soft-skills" like group facilitation are important, we recommend continuous monitoring and mentoring throughout program implementation to strengthen these new skills, provide corrective feedback and guard against skills decay. We suggest the use of quantitative tools to provide direct measures of implementation fidelity over time and qualitative tools to gain a more complete understanding of what factors influence implementation fidelity. Identifying areas of implementation requiring additional support and mentoring may ensure effective translation of evidence-based interventions into real-world settings.

Defining and estimating effects in cluster randomized trials: A methods comparison.

Across research disciplines, cluster randomized trials (CRTs) are commonly implemented to evaluate interventions delivered to groups of participants, such as communities and clinics. Despite advances in the design and analysis of CRTs, several challenges remain. First, there are many possible ways to specify the causal effect of interest (eg, at the individual-level or at the cluster-level). Second, the theoretical and practical performance of common methods for CRT analysis remain poorly understood. Here, we present a general framework to formally define an array of causal effects in terms of summary measures of counterfactual outcomes. Next, we provide a comprehensive overview of CRT estimators, including the t-test, generalized estimating equations (GEE), augmented-GEE, and targeted maximum likelihood estimation (TMLE). Using finite sample simulations, we illustrate the practical performance of these estimators for different causal effects and when, as commonly occurs, there are limited numbers of clusters of different sizes. Finally, our application to data from the Preterm Birth Initiative (PTBi) study demonstrates the real-world impact of varying cluster sizes and targeting effects at the cluster-level or at the individual-level. Specifically, the relative effect of the PTBi intervention was 0.81 at the cluster-level, corresponding to a 19% reduction in outcome incidence, and was 0.66 at the individual-level, corresponding to a 34% reduction in outcome risk. Given its flexibility to estimate a variety of user-specified effects and ability to adaptively adjust for covariates for precision gains while maintaining Type-I error control, we conclude TMLE is a promising tool for CRT analysis.

Cost analysis of an intrapartum quality improvement package for improving preterm survival and reinforcing best practices in Kenya and Uganda.

INTRODUCTION: Preterm birth is a leading cause of under-5 mortality, with the greatest burden in lower-resource settings. Strategies to improve preterm survival have been tested, but strategy costs are less understood. We estimate costs of a highly effective Preterm Birth Initiative (PTBi) intrapartum intervention package (data strengthening, WHO Safe Childbirth Checklist, simulation and team training, quality improvement collaboratives) and active control (data strengthening, Safe Childbirth Checklist). METHODS: In our analysis, we estimated costs incremental to current cost of intrapartum care (in 2020 $US) for the PTBi intervention package and active control in Kenya and Uganda. We costed the intervention package and control in two scenarios: 1) non-research implementation costs as observed in the PTBi study (Scenario 1, mix of public and private inputs), and 2) hypothetical costs for a model of implementation into Ministry of Health programming (Scenario 2, mostly public inputs). Using a healthcare system perspective, we employed micro-costing of personnel, supplies, physical space, and travel, including 3 sequential phases: program planning/adaptation (9 months); high-intensity implementation (15 months); lower-intensity maintenance (annual). One-way sensitivity analyses explored the effects of uncertainty in Scenario 2. RESULTS: Scenario 1 PTBi package total costs were $1.11M in Kenya ($48.13/birth) and $0.74M in Uganda ($17.19/birtth). Scenario 2 total costs were $0.86M in Kenya ($23.91/birth) and $0.28M in Uganda ($5.47/birth); annual maintenance phase costs per birth were $16.36 in Kenya and $3.47 in Uganda. In each scenario and country, personnel made up at least 72% of total PTBi package costs. Total Scenario 2 costs in Uganda were consistently one-third those of Kenya, largely driven by differences in facility delivery volume and personnel salaries. CONCLUSIONS: If taken up and implemented, the PTBi package has the potential to save preterm lives, with potential steady-state (maintenance) costs that would be roughly 5-15% of total per-birth healthcare costs in Uganda and Kenya.

Simulation and team training to improve preterm birth knowledge, evidence-based practices, and communication skills in midwives in Kenya and Uganda: Findings from a pre- and post-intervention analysis.

Simulation training in basic and emergency obstetric and neonatal care has previously shown success in reducing maternal and neonatal mortality in low-resource settings. Though preterm birth is the leading cause of neonatal deaths, application of this training methodology geared specifically towards reducing preterm birth mortality and morbidity has not yet been implemented and evaluated. The East Africa Preterm Birth Initiative (PTBi-EA) was a multi-country cluster randomized controlled (CRCT) trial that successfully improved outcomes of preterm neonates in Migori County, Kenya and the Busoga region of Uganda through an intrapartum package of interventions. PRONTO simulation and team training (STT) was one component of this package and was introduced to maternity unit providers in 13 facilities. This analysis was nested within the larger CRCT and specifically looked at the impact of the STT portion of the intervention package. The PRONTO STT curriculum was modified to emphasize prematurity-related intrapartum and immediate postnatal care practices, such as assessment of gestational age, identification of preterm labour, and administration of antenatal corticosteroids. Knowledge and communication techniques were assessed at the beginning and end of the intervention through a multiple-choice knowledge test. Clinical skills and communication techniques used in context were assessed through the use of evidence-based practiced (EBPs) as documented in video-recorded simulations through StudioCodeTM video analysis. Pre-and-post scores were compared in both categories using Chi-squared tests. Knowledge assessment scores improved from 51% to 73% with maternal-related questions improving from 61% to 74%, neonatal questions from 55% to 73%, and communication technique questions from 31% to 71%. The portion of indicated preterm birth EBPs performed in simulation increased from 55% to 80% with maternal-related EBPs improving from 48% to 73%, neonatal-related EBPs from 63% to 93%, and communication techniques from 52% to 69%. STT substantially increased preterm birth-specific knowledge and EBPs performed in simulation.

A comic based interactive digital intervention to enhance facilitation skills of nurse mentors in public facilities - results of a pilot intervention in Bihar, India.

BACKGROUND: Various trainings are designed to educate nurses to become simulation educators. However, there are no good strategies to sustain their learnings and keep them engaged. We developed a series of 10 interactive digital storytelling comic episodes 'The Adventures of Super Divya (SD)' to strengthen simulation educator's facilitation knowledge, skills, confidence, and engagement. This endline evaluation presents results on the change in knowledge after watching the episodes and retention of that knowledge over 10 months. OBJECTIVES: The objectives of this pilot study are to: 1) assess the change in knowledge between the baseline and post-episode surveys; and 2) understand the retention of knowledge between the post-episode and the endline survey. METHODS: A human-centred design was used to create the episodes grounded in the lived experience of nurse simulation educators. The heroine of the comic is Divya, a 'Super Facilitator' and her nemesis is Professor Agni who wants to derail simulation as an educational strategy inside obstetric facilities. Professor Agni's schemes represent real-life challenges; and SD uses effective facilitation and communication to overcome them. The episodes were shared with a group of nurse mentors (NM) and nurse mentor supervisors (NMS) who were trained to be champion simulation educators in their own facilities. To assess change in knowledge, we conducted a baseline, nine post-episode surveys and an endline survey between May 2021 and February 2022. RESULTS: A total 110 NM and 50 NMS watched all 10 episodes and completed all of the surveys. On average, knowledge scores increased by 7-9 percentage points after watching the episodes. Comparison of survey responses obtained between 1 and 10 months suggest that the gain in knowledge was largely retained over time. CONCLUSIONS: Findings suggest that this interactive comic series was successful in a resource limited setting at engaging simulation educators and helped to maintain their facilitation knowledge over time.

Context Matters: Factors Affecting Implementation of Simulation Training in Nursing and Midwifery Schools in North America, Africa and Asia.

Background: Robust evidence supports the effectiveness of simulation training in nursing and midwifery education. Simulation allows trainees to apply newly-learned skills in a supportive environment. Method: This study was conducted using the Consolidated Framework for Implementation Research (CFIR). We conducted in-depth individual interviews with simulation experts around the world. Results: Findings from this study highlight best-practices in facilitating simulation implementation across resources settings. Universal accelerators included: (1) adaptability of simulation (2) "simulation champions" (3) involving key stakeholders and (4) culturally-informed, pre-implementation planning. Conclusions: Shared constructs reported in diverse settings provide lessons to implementing evidence-based, flexible simulation trainings in pre-service curriculum.

Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial.

Background: A large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda. Methods: Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers. Results: Of the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); Pinteraction = 0.025. These trends were similar after excluding the PTBi primary cohort. Conclusions: The intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries. Registration: This trial is registered with ClinicalTrials.gov, NCT03112018.

Training nurse simulation educators at scale to improve maternal and newborn health: a case study from Bihar, India.

BACKGROUND: Simulation has been shown to improve clinical and behavioral skills of birth attendants in low-resource settings at a low scale. Populous, low-resource settings such as Bihar, India, require large cadres of simulation educators to improve maternal and newborn health. It's unknown if simulation facilitation skills can be adopted through a train of trainers' cascade. To fill this gap, we designed a study to evaluate the simulation and debrief knowledge, attitudes and skills of a third generation of 701 simulation educators in Bihar, India. In addition, we assessed the physical infrastructure where simulation takes place in 40 primary healthcare facilities in Bihar, India. METHODS: We performed a 1 year before-after intervention study to assess the simulation facilitation strengths and weaknesses of a cadre of 701 nurses in Bihar, India. The data included 701 pre-post knowledge and attitudes self-assessments; videos of simulations and associated debriefs conducted by 701 providers at 40 primary healthcare centers. RESULTS: We observed a statistically significant difference in knowledge and attitude scores before and after the 4-day PRONTO simulation educator training. The average number of participants in a simulation video was 5 participants (range 3-8). The average length of simulation videos was 10:21 minutes. The simulation educators under study, covered behavioral in 90% of debriefs and cognitive objectives were discussed in all debriefs. CONCLUSION: This is the first study assessing the simulation and debrief facilitation knowledge and skills of a cadre of 701 nurses in a low-resource setting. Simulation was implemented by local nurses at 353 primary healthcare centers in Bihar, India. Primary healthcare centers have the physical infrastructure to conduct simulation training. Some simulation skills such as communication via whiteboard were widely adopted. Advanced skills such as eliciting constructive feedback without judgment require practice.

A landscaping review of interventions to promote respectful maternal care in Africa: Opportunities to advance innovation and accountability.

OBJECTIVE: In the past decade, global recognition of the need to address disrespect and abuse (also described as mistreatment of women) and promote respectful maternal care in facility-based childbirth has increased. While many studies have documented gaps in respectful maternal care, little is known about the design and implementation of these interventions. Our aim was to summarize and describe respectful maternal care -promoting interventions during childbirth implemented in Africa. DESIGN: We identified respectful maternal care -promoting interventions in Africa through a rapid scoping of peer-reviewed articles and gray literature, and a crowdsourcing survey distributed through stakeholder networks. SETTING: Africa PARTICIPANTS: NA MEASUREMENTS AND FINDINGS: We identified 43 unique interventions implemented in 16 African countries, gathered from a crowdsourcing survey, gray and published literature between 2010 and 2020. Most interventions were implemented in East Africa (N = 13). The interventions had various targets and were categorized into nine approaches, 60% of interventions focused on training providers about respectful maternal care and practice. About two thirds included multiple intervention approaches, and about two thirds addressed respectful maternal care beyond the period of childbirth. Few publications presented data on the effectiveness of the intervention, and those that did used a wide variety of indicators. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: There is a reliance on provider training approaches to promote respectful maternal care and there are few examples of either engaging women in the community or adopting social accountability approaches. We encourage implementors to develop interventions targeting multiple approaches beyond provider training and consider delivery across pre-pregnancy, pregnancy, birth, and the postnatal periods. Finally, in order to effectively move from documenting respectful maternal care gaps to action and scale, we need global consensus on common indicators and measures of effectiveness for interventions promoting respectful care across the life course.

The role of informational support from women's social networks on antenatal care initiation: qualitative evidence from pregnant women in Uganda.

BACKGROUND: Early and appropriate use of antenatal care services is critical for reducing maternal and neonatal mortality and morbidity. Yet most women in sub-Saharan Africa, including Uganda, do not seek antenatal care until later during pregnancy. This qualitative study explored pregnant women's reliance on social ties for information about initiation of antenatal care. METHODS: We conducted semi-structured, in-depth interviews with 30 pregnant women seeking their first antenatal care visit at Kawempe Referral Hospital in Kampala, Uganda. Recruitment was done purposively to obtain variation by parity and whether women currently had a male partner. Study recruitment occurred from August 25th 2020 - October 26th, 2020. We used thematic analysis following a two-stage coding process, with both deductive and inductive codes. Deductive codes followed the key domains of social network and social support theory. RESULTS: We found that the most important source of information about antenatal care initiation was these women's mothers. Other sources included their mothers-in-law, female elders including grandmothers, and male partners. Sisters and female friends were less influential information sources about antenatal initiation. One of the primary reasons for relying on their own mothers, mothers-in-law, and elder women was due to these women's lived experience with pregnancy and childbirth. Trust in the relationship was also an important factor. Some pregnant women were less likely to rely on their sisters or female friends, either due to lack of trust or these women's lack of experience with pregnancy and childbirth. The advice that pregnant women received from their mothers and others on the ideal timing for antenatal care initiation varied significantly, including examples of misinformation about when to initiate antenatal care. Pregnant women seemed less likely to delay care when more than one social tie encouraged early antenatal care. CONCLUSIONS: Educating women's social networks, especially their mothers, mothers-in-law, and community elders, about the importance of early antenatal care initiation is a promising avenue for encouraging pregnant women to seek care earlier in pregnancy.

Meeting demand-Obstetric hemorrhage and blood availability in Malawi, a qualitative study.

BACKGROUND: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in Malawi. Despite the presence of a centralized institution supplying blood and blood products for hospitals across the country, a lack of timely blood transfusion has been identified as a critical barrier to successful PPH management. This study aims to understand the factors that affect the blood delivery pipeline and adequate access to blood products for postpartum haemorrhage patients. METHODS: Qualitative data were collected through in-depth interviews with key stakeholders across the blood delivery pipeline. Interviews were conducted from July 2020 to January 2021 at Queen Elizabeth Central Hospital and Mulanje District Hospital, a referral and district hospital respectively, as well as the Malawi Blood Transfusion Service. Line by line, open coding was used to perform a thematic analysis of the data using Nvivo and Atlas.ti software. RESULTS: Five key themes were identified: 1) Lack of blood availability due to an inadequate donor pool, 2) Transportation of blood products and PPH patients is impeded by distance to target sites and competing interests for blood delivery vehicles, 3) The Malawi Blood Transfusion Service has difficulty meeting demand for blood products due to inadequate funding and difficulty retaining blood donors, 4) Current PPH management protocols and practices lead to delays due to inconsistent guidelines on delivery and analysis of patient samples, and 5) Communication between health cadres is inconsistent and affected by a lack of adequate resources. CONCLUSIONS: Barriers to timely blood transfusion for PPH patients exist across the blood delivery pipeline. While an investment of infrastructure would alleviate many obstacles, several solutions identified in this study can be implemented without additional resources, such as establishing joint department meetings to improve communication between health cadres. Ultimately, given a resource limited setting, it may be worth considering de-centralizing the blood supply.