Executive Summary: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE (PEACE) Consensus Conference.

OBJECTIVES: To present recommendations and consensus statements with supporting literature for the clinical management of neonates and children supported with extracorporeal membrane oxygenation (ECMO) from the Pediatric ECMO Anticoagulation CollaborativE (PEACE) consensus conference. DATA SOURCES: Systematic review was performed using PubMed, Embase, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021, followed by serial meetings of international, interprofessional experts in the management ECMO for critically ill children. STUDY SELECTION: The management of ECMO anticoagulation for critically ill children. DATA EXTRACTION: Within each of eight subgroup, two authors reviewed all citations independently, with a third independent reviewer resolving any conflicts. DATA SYNTHESIS: A systematic review was conducted using MEDLINE, Embase, and Cochrane Library databases, from January 1988 to May 2021. Each panel developed evidence-based and, when evidence was insufficient, expert-based statements for the clinical management of anticoagulation for children supported with ECMO. These statements were reviewed and ratified by 48 PEACE experts. Consensus was obtained using the Research and Development/UCLA Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed 23 recommendations, 52 expert consensus statements, and 16 good practice statements covering the management of ECMO anticoagulation in three broad categories: general care and monitoring; perioperative care; and nonprocedural bleeding or thrombosis. Gaps in knowledge and research priorities were identified, along with three research focused good practice statements. CONCLUSIONS: The 91 statements focused on clinical care will form the basis for standardization and future clinical trials.

Improving neonatal health with family-centered, early postnatal care: A quasi-experimental study in India.

Despite the global decline, neonatal mortality rates (NMR) remain high in India. Family members are often responsible for the postpartum care of neonates and mothers. Yet, low health literacy and varied beliefs can lead to poor health outcomes. Postpartum education for family caregivers, may improve the adoption of evidence-based neonatal care and health outcomes. The Care Companion Program (CCP) is a hospital-based, pre-discharge health training session where nurses teach key healthy behaviors to mothers and family members, including skills and an opportunity to practice them in the hospital. We conducted a quasi-experimental study to assess the effect of the CCP sessions on mortality outcomes among families seeking care in 28 public tertiary facilities across 4 Indian states. Neonatal mortality outcomes were reported post-discharge, collected via phone surveys at four weeks postpartum, between October 2018 to February 2020. Risk ratios (RR), adjusting for hospital-level clustering, were calculated by comparing mortality rates before and after CCP implementation. A total of 46,428 families participated in the pre-intervention group and 87,305 in the post-intervention group; 76% of families completed the phone survey. Among the 33,599 newborns born before the CCP implementation, there were 1386 deaths (NMR: 41.3 deaths per 1000 live births). After the intervention began, there were 2021 deaths out of 60,078 newborns born (crude NMR: 33.6 deaths per 1000 live births, RR = 0.82, 95% CI: 0.76, 0.87; cluster-adjusted RR = 0.82, 95% CI: 0.71, 0.94). There may be a substantial benefit to family-centered education in the early postnatal period to reduce neonatal mortality.

Qualitative assessment of family caregiver-centered neonatal education program in Karnataka, India.

Globally 2.5 million newborns die every year before they reach the age of one month; the majority of these deaths occur in low- and middle-income countries. Among other factors, inadequate knowledge and skills to take care of newborns contribute to these deaths. To fill this gap, training patients and family members on the behaviors needed to improve essential newborn care practices at home is a promising opportunity. One program that aims to do this is the Care Companion Program (CCP) which provides in-hospital, skills-based training on care of mothers and newborns to families. This study uses semi-structured interviews to understand how and why knowledge and behaviors of maternal and newborn care behaviors change (or don't change) as a result of CCP sessions and participants' perception of the impact of CCP on change. Interviews focused on knowledge and behaviors around key neonatal and newborn topics and health seeking behaviors for health complications. Forty-two in-depth interviews were conducted among families with recently-delivered babies at their homes from four districts in Karnataka, India. Respondents have a positive perception about CCP, found training useful and appreciated other family members presence during the training. CCP increased knowledge and awareness and provided critical details to key behaviors like breastfeeding. Respondents were more likely to be receptive toward details on already known topics, like hand washing before touching the baby. Awareness increased on newly learned behaviors, like skin-to-skin care, which don't conflict with cultural norms. The CCP did not influence nonrestrictive maternal diet as much, which cultural norms heavily influence. In-hospital family caregiver education programs, like CCP, can positively influence key neonatal behaviors by imparting knowledge and key skills. However, the effect is not universal across health behaviors.

Does Quality Certification Work? An Assessment of Manyata, a Childbirth Quality Program in India's Private Sector.

BACKGROUND: In India, more than 60% of hospital beds are in private facilities, yet several studies have observed suboptimal quality of care in private facilities. We aimed to understand the role of Manyata, a quality improvement initiative in private facilities focused on mentorship and clinical standards, to improve the knowledge and skills of health care providers, their adherence to key childbirth-related clinical practices, and health outcomes for women and newborns. METHODS: We conducted a secondary analysis of Manyata program data collected from 466 private facilities across 3 states (Jharkhand, Maharashtra, and Uttar Pradesh) in India from October 2016 to February 2019. We calculated means and 95% confidence intervals for knowledge and skills assessment, adherence to facility standards was analyzed by calculating the proportion of facilities passing a given quality standard at baseline and endline, and changes in pregnancy outcomes were assessed with autoregression modeling. RESULTS: From assessments conducted before and after training among providers in Manyata, we observed a significant increase in average knowledge score (6.3 vs. 13.2 of 20) and skill score (8.0 vs. 34.3 of 40). Overall, a significant increase occurred in adherence to clinical standards between baseline and endline assessments (29% vs. 93%). The standards with the greatest improvements were identification and management of eclampsia/preeclampsia, postpartum hemorrhage, and neonatal resuscitation. There were no significant changes over time in absolute rate of reported complications; however, referral rates from private facilities for preeclampsia and newborn sepsis identification and management declined. CONCLUSION: Our analysis indicates private facilities' adherence to quality standards and nurses' childbirth knowledge and practical skills increased during Manyata. Additional efforts are needed to ensure high-quality care during cesarean deliveries at private facilities. Future studies with rigorous design are required to evaluate the impact of this quality improvement initiative in improving pregnancy outcomes.

Estimating maternity ward birth attendant time use in India: a microcosting study.

OBJECTIVES: Despite global concern over the quality of maternal care, little is known about the time requirements to complete the essential birth practices. Using three microcosting data collection methods within the BetterBirth trial, we aimed to assess time use and the specific time requirements to incorporate the WHO Safe Childbirth Checklist into clinical practice. SETTING: We collected detailed survey data on birth attendant time use within the BetterBirth trial in Uttar Pradesh, India. The BetterBirth trial tested whether the peer-coaching-based implementation of the WHO Checklist was effective in improving the quality of facility-based childbirth care. PARTICIPANTS: We collected measurements of time to completion for 18 essential birth practices from July 2016 through October 2016 across 10 facilities in five districts (1559 total timed observations). An anonymous survey asked about the impact of the WHO Checklist on birth attendants at every intervention facility (15 facilities, 83 respondents) in the Lucknow hub. Additionally, data collectors visited facilities to conduct a census of patients and birth attendants across 20 facilities in seven districts between June 2016 and November 2016 (six hundred and ten 2-hour facility observations). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure of this study is the per cent of staff time required to complete the essential birth practices included in the WHO Checklist. RESULTS: When birth attendants were timed, we found practices were completed rapidly (18 s to 2 min). As the patient load increased, time dedicated to clinical care increased but remained low relative to administrative and downtime. On average, WHO Checklist clinical care accounted for less than 7% of birth attendant time use per hour. CONCLUSIONS: We did not find that a coaching-based implementation of the WHO Checklist was a burden on birth attendant's time use. However, questions remain regarding the performance quality of practices and how to accurately capture and interpret idle and break time. TRIAL REGISTRATION NUMBER: NCT02148952.

Principled Subpopulation Analysis of the BetterBirth Study and the Impact of WHO's Safe Childbirth Checklist Intervention.

The World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. The original study reported that the intervention did not significantly improve the outcomes. In this work, we employ a principled data-driven analysis to identify subpopulations with divergent characteristics: 1) vulnerable subgroups with the highest risk of neonatal deaths and 2) subgroups in the intervention arm that benefited from the Checklist intervention with significantly reduced risks of deaths and complications. Results demonstrate that low birth weight represented the most vulnerable group, whereas mother-baby dyads described by normal gestational age at birth, known parity, and unknown number of abortions was found to benefit from the Checklist intervention (OR : 0.70, 95%CI : 0.62-0.79, p < 0.001). Generally, the flexibility of our approach helps to answer subgroup-based queries in the broader global health domain, which also provides further insights to domain experts.

Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol.

INTRODUCTION: Ending 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, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%-80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy. METHODS AND ANALYSIS: LIFE 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 DISSEMINATION: This 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 NUMBERS: NCT04002908 and CTRI/2019/02/017475.

The effect of milk type and fortification on the growth of low-birthweight infants: An umbrella review of systematic reviews and meta-analyses.

Approximately 15% of infants worldwide are born with low birthweight (<2500 g). These children are at risk for growth failure. The aim of this umbrella review is to assess the relationship between infant milk type, fortification and growth in low-birthweight infants, with particular focus on low- and lower middle-income countries. We conducted a systematic review in PubMed, CINAHL, Embase and Web of Science comparing infant milk options and growth, grading the strength of evidence based on standard umbrella review criteria. Twenty-six systematic reviews qualified for inclusion. They predominantly focused on infants with very low birthweight (<1500 g) in high-income countries. We found the strongest evidence for (1) the addition of energy and protein fortification to human milk (donor or mother's milk) leading to increased weight gain (mean difference [MD] 1.81 g/kg/day; 95% confidence interval [CI] 1.23, 2.40), linear growth (MD 0.18 cm/week; 95% CI 0.10, 0.26) and head growth (MD 0.08 cm/week; 95% CI 0.04, 0.12) and (2) formula compared with donor human milk leading to increased weight gain (MD 2.51 g/kg/day; 95% CI 1.93, 3.08), linear growth (MD 1.21 mm/week; 95% CI 0.77, 1.65) and head growth (MD 0.85 mm/week; 95% CI 0.47, 1.23). We also found evidence of improved growth when protein is added to both human milk and formula. Fat supplementation did not seem to affect growth. More research is needed for infants with birthweight 1500-2500 g in low- and lower middle-income countries.

Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial.

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.

Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India.

BACKGROUND: Evidence-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. METHODS: Within 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. FINDINGS: Across 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. INTERPRETATION: Adherence 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. FUNDING: Bill & Melinda Gates Foundation. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.

Who's your coach? The relationship between coach characteristics and birth attendants' adherence to the WHO Safe Childbirth Checklist.

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.

Just-in-time postnatal education programees to improve newborn care practices: needs and opportunities in low-resource settings.

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.

Coaching Intensity, Adherence to Essential Birth Practices, and Health Outcomes in the BetterBirth Trial in Uttar Pradesh, India.

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.

Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial.

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.

Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth).

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 (<95 births per month), our models estimated perinatal mortality was 17 (95% CI 11·7-24·8) per 1000 births in the intervention group versus 38 (31·6-44·8) per 1000 in the control group (p<0·0001). INTERPRETATION: Mortality was not directly associated with measured facility-level indicators but was associated with general risk factors. The absence of correlation between expected predictors and patient outcomes and the association between improved outcomes and the intervention in smaller facilities suggest a need for additional measures of quality of care that take into account complexity. FUNDING: Bill & Melinda Gates Foundation.

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India.

OBJECTIVE: To evaluate whether integration of the Opportunity-Ability-Motivation plus Supplies (OAMS) framework into coaching improved the delivery of essential birth practices in a low-resource setting. METHODS: This prospective mixed-methods study used routine coaching visit data obtained from the first eight intervention facilities of the BetterBirth trial in Uttar Pradesh, India, between December 19, 2014, and October 21, 2015. The 8-month intervention was peer coaching that integrated the OAMS framework to support uptake of the WHO Safe Childbirth Checklist. Descriptive statistics were used to measure nonadherence to essential birth practices. The frequency and accuracy of coaches' coding of barriers and the appropriateness of chosen resolution strategies to measure feasibility, acceptability, and fidelity of using OAMS, were assessed. RESULTS: Coaches observed 666 deliveries, including 12 602 practices. Overall, essential practice nonadherence decreased from 15.6% (262/1675 practices observed) to 4.5% (4/88 practices) (P<0.001). Of the 1048 barriers identified, opportunity (556 [53.1%]) and motivation (287 [27.4%]) were the most frequently reported categories; the frequency of both decreased over time (P=0.003 and P<0.001, respectively). The coaches appropriately categorized 930 (99.8%) of 932 barriers and provided an appropriate strategy for 800 (85.8%). The commonest reason for unaddressed barriers was lack of coaching opportunities. CONCLUSION: Successful integration of OAMS framework into delivery attendant coaching enabled coaches to rapidly diagnose barriers to practice adherence and develop responsive strategies. CLINICALTRIALS.GOV: NCT2148952 (WHO Universal Trial Number: U11111-1315-647).

Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India.

BACKGROUND: The prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes. METHODS: We conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention. RESULTS: Of 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes. CONCLUSIONS: Birth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).