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Despite increasing cesarean rates in Africa, there remain extensive gaps in the standard provision of care after cesarean birth. We present recommendations for discharge instructions to be provided to women following cesarean delivery in Rwanda, particularly rural Rwanda, and with consideration of adaptable guidelines for sub-Saharan Africa, to support recovery during the postpartum period. These guidelines were developed by a Technical Advisory Group comprised of clinical, program, policy, and research experts with extensive knowledge of cesarean care in Africa. The final instructions delineate between normal and abnormal recovery symptoms and advise when to seek care. The instructions align with global postpartum care guidelines, with additional emphasis on care practices more common in the region and address barriers that women delivering via cesarean may encounter in Africa. The recommended timeline of postpartum visits and visit activities reflect the World Health Organization protocols and provide additional activities to support women who give birth via cesarean. These guidelines aim to standardize communication with women at the time of discharge after cesarean birth in Africa, with the goal of improved confidence and clinical outcomes among these individuals.

Background: World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. In the primary BetterBirth traditional trial analysis, the intervention did not significantly improve . However, a novel subgroup-based analysis could identify subpopulations that benefited from the intervention. Methods: In this work, we employ data-driven analysis methods to identify differentiated subgroups with unexpected characteristics compared to the average population. Specifically, we aim to identify: 1) vulnerable subgroups and 2) subpopulation in the intervention arm with significantly reduced outcome. The method utilizes the existing subset scanning literature that searches over a combination of features to identify the differentiated groups. Findings: We found that low birthweight (

Frequent coaching was associated with increased adherence to evidence-based essential birth practices among birth attendants but not with improved maternal and perinatal health outcomes in the BetterBirth Trial, which assessed the impact of a complex intervention to implement the World Health Organization's Safe Childbirth Checklist. To promote sustainable behavior change, future coaching-based interventions may need to explore cost-effective, feasible mechanisms for providing more frequent coaching delivered with high coverage among health care workers for longer durations., Background: Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. Methods: For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. Results: Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. Conclusions: Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.

Background Ensuring the right to respectful care for maternal and newborn health, a critical dimension of quality and acceptability, requires meeting standards for Respectful Maternity Care (RMC). Absence of mistreatment does not constitute RMC. Evidence generation to inform definitional standards for RMC is in an early stage. The aim of this systematic review is clear provider-level operationalization of key RMC principles, to facilitate their consistent implementation. Methods Two rights-based frameworks define the underlying principles of RMC. A qualitative synthesis of both frameworks resulted in seven fundamental rights during childbirth that form the foundation of RMC. To codify operational definitions for these key elements of RMC at the healthcare provider level, we systematically reviewed peer-reviewed literature, grey literature, white papers, and seminal documents on RMC. We focused on literature describing RMC in the affirmative rather than mistreatment experienced by women during childbirth, and operationalized RMC by describing objective provider-level behaviors. Results Through a systematic review, 514 records (peer-reviewed articles, reports, and guidelines) were assessed to identify operational definitions of RMC grounded in those rights. After screening and review, 54 records were included in the qualitative synthesis and mapped to the seven RMC rights. The majority of articles provided guidance on operationalization of rights to freedom from harm and ill treatment; dignity and respect; information and informed consent; privacy and confidentiality; and timely healthcare. Only a quarter of articles mentioned concrete or affirmative actions to operationalize the right to non-discrimination, equality and equitable care; less than 15%, the right to liberty and freedom from coercion. Provider behaviors mentioned in the literature aligned overall with seven RMC principles; yet the smaller number of available research studies that included operationalized definitions for some key elements of RMC illustrates the nascent stage of evidence-generation in this area. Conclusions Lack of systematic codification, grounded in empirical evidence, of operational definitions for RMC at the provider level has limited the study, design, implementation, and comparative assessment of respectful care. This qualitative systematic review provides a foundation for maternity healthcare professional policy, training, programming, research, and program evaluation aimed at studying and improving RMC at the provider level., Plain Language Summary Respectful care for mothers and newborns is a right and important part of ensuring that their care is high quality and acceptable to them. Just because there is no mistreatment does not mean that Respectful Maternity Care (RMC) was given. Without a clear framework for provider behaviors that reflect RMC principles, it is hard to ensure every woman and newborn gets respectful care in practice. We compared and combined two frameworks summarizing maternal and newborn rights and came out with seven categories. Then we searched for articles that mentioned provider behaviors reflecting RMC. We found 514 articles and ended up with 54 after careful review, from which we pulled the observable behaviors for providers in each category. Almost all papers mentioned actions to protect women and newborns from harm and mistreatment, to treat them with dignity and respect, and to give information and respect choices. About half of papers mentioned actions to protect privacy and to make sure every mother and newborn gets care when needed. Only 25% of papers mentioned actions to make sure all women and newborns receive equal care, and only 15% included actions to make sure women and newborns are physically free to leave facilities at will, and get care whether or not they can pay. This framework defining RMC behaviors for providers is based on data from many studies and can be useful to look at whether maternal newborn care in facilities meets these standards and to inform training and more research to improve RMC.

IntroductionPreterm birth is the leading cause of child mortality. This study aimed to develop and validate programmatically feasible and accurate approaches to estimate newborn gestational age (GA) in low resource settings.MethodsThe WHO Alliance for Maternal and Newborn Health Improvement (AMANHI) study recruited pregnant women from population-based cohorts in five countries (Bangladesh, Ghana, Pakistan, Tanzania and Zambia). Women Results7428 liveborn infants were included (n=536 preterm, ConclusionThe best machine-learning model (10 neonatal characteristics and LMP) estimated GA within ±15.7 days of early ultrasound dating. Simpler models performed reasonably well with marginal increases in prediction error. These models hold promise for newborn GA estimation when ultrasound dating is unavailable.

Background Accurate assignment of the gestational age of newborns is important for the identification of prematurity. The Dubowitz assessment is the gold standard among postnatal examinations used to assign gestational age, but implementation has been limited because of examination complexity and training requirements. The objective of this study was to explore factors related to teaching and implementing the Dubowitz examination that may influence its uptake in India and Malawi. Methods This cross-sectional study was conducted in India and Malawi during the preparation for a low-birthweight infant feeding exploratory study. Twenty trainees participated in a Dubowitz examination training workshop that occurred over two half-day sessions. Trainees completed pretraining and posttraining surveys related to their perceptions of the Dubowitz training, the examination, and factors affecting the administration of the examination in their setting. Results All survey respondents expressed confidence in their ability to perform the Dubowitz examination after the training. Less than a third expressed concerns about the time required to learn (30%) or perform the examination (25%). Eighty-five percent of trainees identified concerns related to parental perception of the examination that may inhibit implementation. Trainees averaged 14 minutes (standard deviation: 4.5 minutes) to complete the examination. More than 80% of trainee answers were within one point of the trainer for 16 of the 22 Dubowitz signs. Trainee composite scores were within ±3 weeks of the trainer for 95% of assessments based on Bland-Altman analysis. Conclusions The Dubowitz examination at birth is a method to improve identification of premature infants in the absence of prenatal dating. We found widespread acceptance for the Dubowitz assessment among participants in training workshops in India and Malawi, despite the complexity and length of the examination. The high level of trainee-trainer concordance on individual examination signs suggests that an acceptable level of competence is feasible after a short, concentrated workshop. Further investigation into barriers that hinder implementation such as negative parental perceptions is warranted. Registration details Clinical Trials Registration: NCT04002908 (www.clinicaltrials.gov) and CTRI/2019/02/017475 (Clinical Trial Registry of India - http://ctri.nic.in).

Background The World Health Organization (WHO) published the WHO Safe Childbirth Checklist in 2015, which included the key evidence-based practices to prevent the major causes of maternal and neonatal morbidity and mortality during childbirth. We assessed the current use of the WHO Safe Childbirth Checklist (SCC) and adaptations regarding the SCC tool and implementation strategies in different contexts from Africa, Southeast Asia, Europe, and North America. Methods This explanatory, sequential mixed methods study—including surveys followed by interviews—of global SCC implementers focused on adaptation and implementation strategies, data collection, and desired improvements to support ongoing SCC use. We analyzed the survey results using descriptive statistics. In a subset of respondents, follow-up virtual semi-structured interviews explored how they adapted, implemented, and evaluated the SCC in their context. We used rapid inductive and deductive thematic analysis for the interviews. Results Of the 483 total potential participants, 65 (13.5%) responded to the survey; 55 completed the survey (11.4%). We analyzed completed responses from those who identified as having SCC implementation experience (n = 29, 52.7%). Twelve interviews were conducted and analyzed. Ninety percent of respondents indicated that they adapted the SCC tool, including adding clinical and operational items. Adaptations to structure included translation into local language, incorporation into a mobile app, and integration into medical records. Respondents reported variation in implementation strategies and data collection. The most common implementation strategies were meeting with stakeholders to secure buy-in, incorporating technical training, and providing supportive supervision or coaching around SCC use. Desired improvements included clarifying the purpose of the SCC, adding guidance on relevant clinical topics, refining items addressing behaviors with low adherence, and integrating contextual factors into decision-making. To improve implementation, participants desired political support to embed SCC into existing policies and ongoing clinical training and coaching. Conclusion Additional adaptation and implementation guidance for the SCC would be helpful for stakeholders to sustain effective implementation.

OBJECTIVE To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India. DESIGN Secondary analysis of a cluster-randomised controlled trial. SETTING Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017. POPULATION Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation. METHODS The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not. MAIN OUTCOME MEASURES Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask. RESULTS We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P

Background Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. Methods and findings This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman’s self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. Conclusions Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. Trial registration The study is not a clinical trial., Author summary Why was this study done? Estimates of severe direct maternal morbidity are largely based on hospital-based studies with inconsistent definitions and varying selection criteria. Limited data are available from South Asia and sub-Saharan Africa, the 2 regions with the highest maternal and newborn morbidity and mortality, where a larger proportion of births occur at home. What did the researchers do and find? We collected data on maternal morbidities from a cohort of women in the community in multiple sites in sub-Saharan Africa and in South Asia. Out of a cohort of >114,000 women, we found that about 1 in 3 women suffer a maternal morbidity, which was notably higher than the previously reported data. We found that the prevalence of preeclampsia and eclampsia was about 1%, which was lower than previously reported. About 11% of women reported having prolonged or obstructed labour, which was somewhat higher than published estimates. The burden of pregnancy-related infection in postpartum period was higher in South Asia than in sub-Saharan Africa. This is the first study, to our knowledge, to describe the burden of antepartum haemorrhage and late antepartum infection and to clearly demonstrate the association of direct maternal morbidity with adverse pregnancy outcomes. What do these findings mean? Higher burden of direct maternal morbidity and its association with adverse outcomes highlights the need for improving health of women and mothers, including promotion of preconception health and nutrition, and high-quality antepartum, intrapartum and postpartum care.

Background Neonatal infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, the timeline of protection, and the benefit of CDKs in home and facility deliveries. Methods and findings A post hoc secondary analysis was performed using nonrandomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamps, plastic sheet, razor blade, matches, and candle, were provided to all pregnant women. Field monitors made a home-based visit to each participant 4 days postpartum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and neonatal mortality rate (NMR). Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and those with missing information. Gloves, cord clamps, and plastic sheets were the most frequently used CDK item combination in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus nonusers. Adjusted logistic regression showed that use of gloves (odds ratio [OR] 0.33, 95% CI 0.24–0.46), cord clamp (OR 0.51, 95% CI 0.38–0.68), plastic sheet (OR 0.46, 95% CI 0.34–0.63), and razor blade (OR 0.69, 95% CI 0.53–0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp were associated with reduced risk of immediate newborn death (, Jason Park and co-workers assess components of clean delivery kits for possible contributions to reduced newborn mortality in a trial done in Zambia., Author summary Why was this study done? Infection during childbirth is a major cause of newborn mortality and morbidity in rural and resource-limited settings. Clean delivery kits can prevent pathogen transmission during infection by providing sterile equipment and encouraging hygienic behaviors. A more nuanced understanding of the benefits of clean delivery kits and their components would aid global implementation to help reduce newborn mortality. What did the researchers do and find? We analyzed the data from the Zambia Chlorhexidine Application Trial (ZamCAT), a cluster-randomized controlled trial conducted in Zambia in 2011–2013. During ZamCAT, we provided clean delivery kits to all mothers in the community and tracked the health outcomes of all women and newborns through the neonatal period. Analysis of 38,579 deliveries showed us that use of gloves, cord clamps, plastic sheets, and razor blades during intrapartum care were associated with lower newborn mortality, in both home and facility deliveries. Components of clean delivery kits were associated with lower risk of perinatal and newborn mortality in the first 7 days of life, but not with mortality between 7 and 28 days of life. What do these findings mean? Components of clean delivery kits that showed highest usage and association with newborn mortality reduction should be included in future clean delivery kit interventions. As this is a post hoc secondary data analysis and the trial was not meant to specifically study the impact of clean delivery kits, causality cannot be inferred. Nevertheless, the large sample size, variation in component use, and study design focused on community settings provide support for clean delivery kits as an intervention that may improve newborn health outcomes in both home and facility deliveries.

Summary: Background: A coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities. Methods: We did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities. Findings: In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (

Objective To evaluate changes in quality of care after implementing an adapted safe childbirth checklist (SCC) in Chiapas, Mexico. Methods A convergent mixed-methods study was conducted among 447 women in labor who attended a rural community hospital between September 1, 2016, and June 30, 2017. Logistic regression analysis was used to evaluate adherence to evidence-based practices over time, adjusting for provider. Participants were surveyed about their perceptions of care after hospital discharge. A purposefully sampled subgroup also completed in-depth interviews. Thematic analysis was performed to evaluate perceptions of care. Results 384 (85.9%) women were attended by staff that used the adapted SCC during delivery. Of these, 221 and 28 completed the hospital discharge survey and in-depth interview, respectively. Adherence with offering a birth companion (odds ratio [OR] 3.06, 95% CI 1.40-6.68), free choice of birth position (2.75, 1.21-6.26), and immediate skin-to-skin contact (4.53, 1.97-10.39) improved 6-8 months after implementation. Participants' perceived quality of care improved over time. Provider communication generated positive perceptions. Reprimanding women for arriving in early labor or complaining of pain generated negative perceptions. Conclusion Use of the adapted SCC improved quality of care through increased adherence with essential and respectful delivery practices.

Approximately 15% of infants worldwide are born with low birthweight (

BackgroundEvidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.MethodsWithin the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants’ practice adherence to perinatal mortality.FindingsAcross 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.InterpretationAdherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.FundingBill & Melinda Gates Foundation.Trial registration detailsClinicalTrials.gov:NCT02148952; Universal Trial Number: U1111-1131-5647.

Worldwide, many newborns die in the first month of life, with most deaths happening in low/middle-income countries (LMICs). Families’ use of evidence-based newborn care practices in the home and timely care-seeking for illness can save newborn lives. Postnatal education is an important investment to improve families’ use of evidence-based newborn care practices, yet there are gaps in the literature on postnatal education programees that have been evaluated to date. Recent findings from a 13 000+ person survey in 3 states in India show opportunities for improvement in postnatal education for mothers and families and their use of newborn care practices in the home. Our survey data and the literature suggest the need to incorporate the following strategies into future postnatal education programming: implement structured predischarge education with postdischarge reinforcement, using a multipronged teaching approach to reach whole families with education on multiple newborn care practices. Researchers need to conduct robust evaluation on postnatal education models incorporating these programee elements in the LMIC context, as well as explore whether this type of education model can work for other health areas that are critical for families to survive and thrive.

Background Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization’s Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions. Methods BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program’s development to illustrate how it could be applied to future studies. Results We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components’ implementation intensities could have been used to identify effective intervention components. Conclusion These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation. Trial registration ClinicalTrials.gov, NCT02148952; registered on May 29, 2014

BACKGROUND: Rigorous monitoring supports progress in achieving maternal and newborn mortality and morbidity reductions. Recent work to strengthen measurement for maternal and newborn health highlights the existence of a large number of indicators being used for this purpose. The definitions and data sources used to produce indicator estimates vary and challenges exist with completeness, accuracy, transparency, and timeliness of data. The objective of this study is to create a conceptual overview of how indicator validity is defined and understood by those who develop and use maternal and newborn health indicators. METHODS: A conceptual framework of validity was developed using mixed methods. We were guided by principles for conceptual frameworks and by a review of the literature and key maternal and newborn health indicator guidance documents. We also conducted qualitative semi-structured interviews with 32 key informants chosen through purposive sampling. RESULTS: We categorised indicator validity into three main types: criterion, convergent, and construct. Criterion or diagnostic validity, comparing a measure with a gold standard, has predominantly been used to assess indicators of care coverage and content. Studies assessing convergent validity quantify the extent to which two or more indicator measurement approaches, none of which is a gold-standard, relate. Key informants considered construct validity, or the accuracy of the operationalisation of a concept or phenomenon, a critical part of the overall assessment of indicator validity. CONCLUSION: Given concerns about the large number of maternal and newborn health indicators currently in use, a more consistent understanding of validity can help guide prioritization of key indicators and inform development of new indicators. All three types of validity are relevant for evaluating the performance of maternal and newborn health indicators. We highlight the need to establish a common language and understanding of indicator validity among the various global and local stakeholders working within maternal and newborn health.

Objective Omphalitis, or umbilical cord infection, is an important cause of newborn morbidity and mortality in low-resource settings. We tested an algorithm that task-shifts omphalitis diagnosis to community-level workers in sub-Saharan Africa. Methods Community-based field monitors and Zambian paediatricians independently evaluated newborns presenting to health facilities in Southern Zambia using a signs and symptoms checklist. Responses were compared against the paediatrician's gold standard clinical diagnosis. Results Of 1009 newborns enrolled, 6.2% presented with omphalitis per the gold standard clinical diagnosis. Paediatricians' signs and symptoms with the highest sensitivity were presence of pus (79.4%), redness at the base (50.8%) and newborn flinching when cord was palpated (33.3%). The field monitor's signs and symptoms answers had low correlation with paediatrician's answers; all signs and symptoms assessed had sensitivity Conclusion Despite extensive training, field monitors could not consistently identify signs and symptoms associated with omphalitis in the sub-Saharan African setting.

Objective Evaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies. Design Matched pair, cluster-randomized controlled trial. Setting Uttar Pradesh, India. Participants 120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites. Interventions Coaching targeting implementation of Checklist with data feedback and action planning. Main Outcome Measures Mean supply availability by study arm; change in procurement sources for intervention sites. Results At baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2–21.5); 22.4 (95% CI: 21.8–22.9) and 22.1 (95% CI:21.4–22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3–21.3); 20.9 (95% CI: 20.3–21.5) and 21.7 (95% CI: 20.8–22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin). Conclusions Implementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications. Trial Registration ClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131–5647

IntroductionEnding preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, Methods and analysisLIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants.Ethics and disseminationThis study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.Trial registration numbersNCT04002908and CTRI/2019/02/017475.

Background Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: -1% to 62%). Conclusion Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.

Background: Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods: We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located

Background In 2014, Vietnam was the first Southeast Asian country to commit to achieving the World Health Organization’s 90–90-90 global HIV targets (90% know their HIV status, 90% on sustained treatment, and 90% virally suppressed) by 2020. This pledge represented further confirmation of Vietnam’s efforts to respond to the HIV epidemic, one feature of which has been close collaboration with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Starting in 2004, PEPFAR supported community outreach programs targeting high-risk populations (people who inject drugs, men who have sex with men, and sex workers). To provide early evidence on program impact, in 2007–2008 we conducted a nationwide evaluation of PEPFAR-supported outreach programs in Vietnam. The evaluation focused on assessing program effect on HIV knowledge, high-risk behaviors, and HIV testing among high-risk populations—results relevant to Vietnam’s push to meet global HIV goals. Methods We used a mixed-methods cross-sectional evaluation design. Data collection encompassed a quantitative survey of 2199 individuals, supplemented by 125 in-depth interviews. Participants were members of high-risk populations who reported recent contact with an outreach worker (intervention group) or no recent contact (comparison group). We assessed differences in HIV knowledge, risky behaviors, and HIV testing between groups, and between high-risk populations. Results Intervention participants knew significantly more about transmission, prevention, and treatment than comparison participants. We found low levels of injection drug-use-related risk behaviors and little evidence of program impact on such behaviors. In contrast, a significantly smaller proportion of intervention than comparison participants reported risky sexual behaviors generally and within each high-risk population. Intervention participants were also more likely to have undergone HIV testing (76.1% vs. 47.0%, p

Government leadership is key to enhancing maternal and newborn survival. In low/middle-income countries, donor support is extensive and multiple actors add complexity. For policymakers and others interested in harmonising diverse maternal and newborn health efforts, a coherent description of project components and their intended outcomes, based on a common theory of change, can be a valuable tool. We outline an approach to developing such a tool to describe the work and the intended effect of a portfolio of nine large-scale maternal and newborn health projects in north-east Nigeria, Ethiopia and Uttar Pradesh in India. Teams from these projects developed a framework, the ‘characterisation framework’, based on a common theory of change. They used this framework to describe their innovations and their intended outcomes. Individual project characterisations were then collated in each geography, to identify what innovations were implemented where, when and at what scale, as well as the expected health benefit of the joint efforts of all projects. Our study had some limitations. It would have been enhanced by a more detailed description and analysis of context and, by framing our work in terms of discrete innovations, we may have missed some synergistic aspects of the combination of those innovations. Our approach can be valuable for building a programme according to a commonly agreed theory of change, as well as for researchers examining the effectiveness of the combined work of a range of actors. The exercise enables policymakers and funders, both within and between countries, to enhance coordination of efforts and to inform decision-making about what to fund, when and where.

Background The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants—nurses and auxiliary nurse midwives (ANMs)—during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. Methods This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). Results Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). Conclusions Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. Trial registration ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111–1131-5647.

BACKGROUND Early initiation of combination antiretroviral therapy (cART) for HIV-positive pregnant women can decrease vertical transmission to less than 5%. Programmatic barriers to early cART include decentralized care, disease-stage assessment delays, and loss to follow-up. INTERVENTION Our intervention had 3 components: integrated HIV and antenatal services in 1 location with 1 provider, laboratory courier to expedite CD4 counts, and community-based follow-up of women-infant pairs to improve prevention of mother-to-child transmission attendance. Preintervention HIV-positive pregnant women were referred to HIV clinics for disease-stage assessment and cART initiation for advanced disease (CD4 count 2). METHODS We used a quasi-experimental design with preintervention/postintervention evaluations at 6 government antenatal clinics (ANCs) in Southern Province, Zambia. Retrospective clinical data were collected from clinic registers during a 7-month baseline period. Postintervention data were collected from all antiretroviral therapy-naive, HIV-positive pregnant women and their infants presenting to ANC from December 2011 to June 2013. RESULTS Data from 510 baseline women-infant pairs were analyzed and 624 pregnant women were enrolled during the intervention period. The proportion of HIV-positive pregnant women receiving CD4 counts increased from 50.6% to 77.2% [relative risk (RR) = 1.81; 95% confidence interval (CI): 1.57 to 2.08; P < 0.01]. The proportion of cART-eligible pregnant women initiated on cART increased from 27.5% to 71.5% (RR = 2.25; 95% CI: 1.78 to 2.83; P < 0.01). The proportion of eligible HIV-exposed infants with documented 6-week HIV PCR test increased from 41.9% to 55.8% (RR = 1.33; 95% CI: 1.18 to 1.51; P < 0.01). CONCLUSIONS Integration of HIV care into ANC and community-based support improved uptake of CD4 counts, proportion of cART-eligible women initiated on cART, and infants tested.

Background: Research demonstrates that coaching is an effective method for promoting behavior change, yet little is known about which attributes of a coach make them more or less effective. This post hoc, sub-analysis of the BetterBirth trial used observational data to explore whether specific coaches’ and team leaders' characteristics were associated with improved adherence to essential birth practices listed on the World Health Organization Safe Childbirth Checklist. Methods: A descriptive analysis was conducted on the coach characteristics from the 50 BetterBirth coaches and team leaders. Data on adherence to essential birth practices by birth attendants who received coaching were collected by independent observers. Bivariate linear regression models were constructed, accounting for clustering by site, to examine the association between coach characteristics and attendants’ adherence to practices. Results: All of the coaches were female and the majority were nurses. Team leaders were comprised of both males and females; half had clinical backgrounds. There was no association between coaches’ or team leaders’ characteristics, namely gender, type of degree, or years of clinical training, and attendants’ adherence to essential birth practices. However, a significant inverse relationship was detected between the coach or team leader’s age and years of experience and the birth attendants’ adherence to the checklist. Conclusion: Younger, less experienced coaches were more successful in promoting essential birth practices adherence in this population. More data is needed to fully understand the relationship between coaches and birth attendants.