Small babies, big risks: global estimates of prevalence and mortality for vulnerable newborns to accelerate change and improve counting.

Small newborns are vulnerable to mortality and lifelong loss of human capital. Measures of vulnerability previously focused on liveborn low-birthweight (LBW) babies, yet LBW reduction targets are off-track. There are two pathways to LBW, preterm birth and fetal growth restriction (FGR), with the FGR pathway resulting in the baby being small for gestational age (SGA). Data on LBW babies are available from 158 (81%) of 194 WHO member states and the occupied Palestinian territory, including east Jerusalem, with 113 (58%) having national administrative data, whereas data on preterm births are available from 103 (53%) of 195 countries and areas, with only 64 (33%) providing national administrative data. National administrative data on SGA are available for only eight countries. Global estimates for 2020 suggest 13·4 million livebirths were preterm, with rates over the past decade remaining static, and 23·4 million were SGA. In this Series paper, we estimated prevalence in 2020 for three mutually exclusive types of small vulnerable newborns (SVNs; preterm non-SGA, term SGA, and preterm SGA) using individual-level data (2010-20) from 23 national datasets (∼110 million livebirths) and 31 studies in 18 countries (∼0·4 million livebirths). We found 11·9 million (50% credible interval [Crl] 9·1-12·2 million; 8·8%, 50% Crl 6·8-9·0%) of global livebirths were preterm non-SGA, 21·9 million (50% Crl 20·1-25·5 million; 16·3%, 14·9-18·9%) were term SGA, and 1·5 million (50% Crl 1·2-4·2 million; 1·1%, 50% Crl 0·9-3·1%) were preterm SGA. Over half (55·3%) of the 2·4 million neonatal deaths worldwide in 2020 were attributed to one of the SVN types, of which 73·4% were preterm and the remainder were term SGA. Analyses from 12 of the 23 countries with national data (0·6 million stillbirths at ≥22 weeks gestation) showed around 74% of stillbirths were preterm, including 16·0% preterm SGA and approximately one-fifth of term stillbirths were SGA. There are an estimated 1·9 million stillbirths per year associated with similar vulnerability pathways; hence integrating stillbirths to burden assessments and relevant indicators is crucial. Data can be improved by counting, weighing, and assessing the gestational age of every newborn, whether liveborn or stillborn, and classifying small newborns by the three vulnerability types. The use of these more specific types could accelerate prevention and help target care for the most vulnerable babies.

National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis.

BACKGROUND: Preterm birth is the leading cause of neonatal mortality and is associated with long-term physical, neurodevelopmental, and socioeconomic effects. This study updated national preterm birth rates and trends, plus novel estimates by gestational age subgroups, to inform progress towards global health goals and targets, and aimed to update country, regional, and global estimates of preterm birth for 2020 in addition to trends between 2010 and 2020. METHODS: We systematically searched population-based, nationally representative data on preterm birth from Jan 1, 2010, to Dec 31, 2020 and study data (26 March-14 April, 2021) for countries and areas with no national-level data. The analysis included 679 data points (86% nationally representative administrative data [582 of 679 data points]) from 103 countries and areas (62% of countries and areas having nationally representative administrative data [64 of 103 data points]). A Bayesian hierarchical regression was used for estimating country-level preterm rates, which incoporated country-specific intercepts, low birthweight as a covariate, non-linear time trends, and bias adjustments based on a data quality categorisation, and other indicators such as method of gestational age estimation. FINDINGS: An estimated 13·4 million (95% credible interval [CrI] 12·3-15·2 million) newborn babies were born preterm (<37 weeks) in 2020 (9·9% of all births [95% CrI 9·1-11·2]) compared with 13·8 million (12·7-15·5 million) in 2010 (9·8% of all births [9·0-11·0]) worldwide. The global annual rate of reduction was estimated at -0·14% from 2010 to 2020. In total, 55·6% of total livebirths are in southern Asia (26·8% [36 099 000 of 134 767 000]) and sub-Saharan Africa (28·7% [38 819 300 of 134 767 000]), yet these two regions accounted for approximately 65% (8 692 000 of 13 376 200) of all preterm births globally in 2020. Of the 33 countries and areas in the highest data quality category, none were in southern Asia or sub-Saharan Africa compared with 94% (30 of 32 countries) in high-income countries and areas. Worldwide from 2010 to 2020, approximately 15% of all preterm births occurred at less than 32 weeks of gestation, requiring more neonatal care (<28 weeks: 4·2%, 95% CI 3·1-5·0, 567 800 [410 200-663 200 newborn babies]); 28-32 weeks: 10·4% [9·5-10·6], 1 392 500 [1 274 800-1 422 600 newborn babies]). INTERPRETATION: There has been no measurable change in preterm birth rates over the last decade at global level. Despite increasing facility birth rates and substantial focus on routine health data systems, there remain many missed opportunities to improve preterm birth data. Gaps in national routine data for preterm birth are most marked in regions of southern Asia and sub-Saharan Africa, which also have the highest estimated burden of preterm births. Countries need to prioritise programmatic investments to prevent preterm birth and to ensure evidence-based quality care when preterm birth occurs. Investments in improving data quality are crucial so that preterm birth data can be improved and used for action and accountability processes. FUNDING: The Children's Investment Fund Foundation and the UNDP, United Nations Population Fund-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

National routine data for low birthweight and preterm births: Systematic data quality assessment for United Nations member states (2000-2020).

OBJECTIVE: Low birthweight (<2500 g) and preterm birth (<37 weeks) are markers of newborn vulnerability. To facilitate informed decisions about investments in prevention and care, it is imperative to enhance data quality and use. Hence, the objective of this study is to systematically assess the quality of data concerning low birthweight and preterm births within routine administrative data sources. DESIGN: Systematic data quality assessment by adopting the WHO Data Quality Framework. SETTING: National routine data system from UN member states. POPULATION: Livebirths. METHODS: National routine administrative data on low birthweight and preterm births for 195 countries from 2000 to 2020 were systematically collated, totalling >700 million live births. The WHO data quality framework was adapted to undertake standardised data quality assessments. MAIN OUTCOME MEASURES: Availability, reporting quality, internal and external consistency of low birthweight and preterm data. RESULTS: Most United States Member States (64%: 124/195) had national data on low birthweight and (40%: 82/195) had data on preterm birth. Routine data system reporting was highest in North America, Australasia and Europe, where more than 95% live births had data on low birthweight and over 75% had data preterm births. In contrast, data reporting was lowest in sub-Saharan Africa (13% for low birthweight, 8% for preterm births) and Southern Asia (16% for low birthweight, 5% for preterm births). Most countries collect individual-level data; but, aggregate data reporting from hospital-based systems remain common in sub-Saharan Africa and Southern Asia. While data quality was generally high in North America, Australasia and Europe, gaps remain in the availability of gestational age metadata. Consistency between low birthweight and preterm rates were poor in Southern Asia and sub-Saharan Africa regions across time. There was high external consistency between low birthweight rates obtained from routine administrative data compared with low birthweight rates obtained from survey data for countries with high data quality. CONCLUSIONS: Sub-Saharan Africa and South Asia countries have data gaps but also opportunities for rapid progress. Most births occure in facilities, electronic health information systems already include low birthweight, and adding accurate gestational age including with ultrasound assessment is becoming increasingly attainable. Moving toward the collection of individual level data would enable monitoring of quality of care and longer-term outcomes. This is crucial for every child and family and essential for measuring progress towards relevant sustainable development goals. The assessment will inform countries' actions for data quality improvement at national level and use of data for impact.

Associations between self-reported obstetric complications and experience of care: a secondary analysis of survey data from Ghana, Kenya, and India.

BACKGROUND: Although several indicators have been proposed to measure women's experience of care in health facilities during the intrapartum period, it is unknown if these indicators perform differently in the context of obstetric emergencies. We examined the relationship between experience of care indicators from the Person-Centered Maternity Care (PCMC) scale and obstetric complications. METHODS: We used data from four cross-sectional surveys conducted in Kenya (rural: N = 873; urban: N = 531), Ghana (N = 531), and India (N = 2018) between August 2016 and October 2017. The pooled sample included 3953 women aged 15-49 years who gave birth within 9 weeks prior to the survey. Experience of care was measured using the PCMC scale. Univariate, bivariate, and multivariable analyses were conducted to examine the associations between the composite and 31 individual PCMC indicators with (1) obstetric complications; (2) severity of complications; and (3) delivery by cesarean section (c-section). RESULTS: 16% (632) of women in the pooled sample reported obstetric complications; and 4% (132) reported having given birth via c-Sect. (10.5% among those with complications). The average standardized PCMC scores (range 0-100) were 63.5 (SD = 14.1) for the full scale, 43.2 (SD = 20.6) for communication and autonomy, 67.8 (SD = 14.1) for supportive care, and 80.1 (SD = 18.2) for dignity and respect sub-scales. Women with complications had higher communication and autonomy scores (45.6 [SD = 20.2]) on average compared to those without complications (42.7 [SD = 20.6]) (p < 0.001), but lower supportive care scores, and about the same scores for dignity and respect and for the overall PCMC. 18 out of 31 experience of care indicators showed statistically significant differences by complications, but the magnitudes of the differences were generally small, and the direction of the associations were inconsistent. In general, women who delivered by c-section reported better experiences. CONCLUSIONS: There is insufficient evidence based on our analysis to suggest that women with obstetric complications report consistently better or worse experiences of care than women without. Women with complications appear to experience better care on some indicators and worse care on others. More studies are needed to understand the relationship between obstetric complications and women's experience of care and to explore why women who deliver by c-section may report better experience of care.

In several studies and reports, women have described mistreatment by health providers during childbirth in health facilities. Particularly in low- and middle-income countries, such mistreatment has negative effects on women's decisions to seek maternity care in health facilities. It is unclear if women with complications are more or less likely to experience some forms of mistreatment compared to women without complications. In this study, we examined 31 experience of care indicators in three domains: (1) Supportive Care; (2) Respect and Dignity; and (3) Communication and Autonomy from the validated Person-Centered Maternity Care (PCMC) questionnaire. We compare these experience of care indicators between women who report obstetric complications and those who don't report complications, by the reported severity of the complications, and by their mode of delivery. The study included data from three countries: Ghana, Kenya, and India. The results showed that the experience of care among women who reported obstetric complications was not consistently better or worse than that of those who did not have complications. Therefore, efforts should be made to improve the experience of care in health facilities for every birthing woman. Additionally, women who delivered via c-section had consistently better experiences than women who delivered vaginally. More studies are needed to understand the relationship between mode of delivery and women's experience of care.

Global core indicators for measuring WHO's paediatric quality-of-care standards in health facilities: development and expert consensus.

BACKGROUND: There are currently no global recommendations on a parsimonious and robust set of indicators that can be measured routinely or periodically to monitor quality of hospital care for children and young adolescents. We describe a systematic methodology used to prioritize and define a core set of such indicators and their metadata for progress tracking, accountability, learning and improvement, at facility, (sub) national, national, and global levels. METHODS: We used a deductive methodology which involved the use of the World Health Organization Standards for improving the quality-of-care for children and young adolescents in health facilities as the organizing framework for indicator development. The entire process involved 9 complementary steps which included: a rapid literature review of available evidence, the application of a peer-reviewed systematic algorithm for indicator systematization and prioritization, and multiple iterative expert consultations to establish consensus on the proposed indicators and their metadata. RESULTS: We derived a robust set of 25 core indicators and their metadata, representing all 8 World Health Organization quality standards, 40 quality statements and 520 quality measures. Most of these indicators are process-related (64%) and 20% are outcome/impact indicators. A large proportion (84%) of indicators were proposed for measurement at both outpatient and inpatient levels. By virtue of being a parsimonious set and given the stringent criteria for prioritizing indicators with "quality measurement" attributes, the recommended set is not evenly distributed across the 8 quality standards. CONCLUSIONS: To support ongoing global and national initiatives around paediatric quality-of-care programming at country level, the recommended indicators can be adopted using a tiered approach that considers indicator measurability in the short-, medium-, and long-terms, within the context of the country's health information system readiness and maturity. However, there is a need for further research to assess the feasibility of implementing these indicators across contexts, and the need for their validation for global common reporting.

Routine Vaccination Coverage - Worldwide, 2020.

Endorsed by the World Health Assembly in 2020, the Immunization Agenda 2030 (IA2030) strives to reduce morbidity and mortality from vaccine-preventable diseases across the life course (1). This report, which updates a previous report (2), presents global, regional,* and national vaccination coverage estimates and trends as of 2020. Changes are described in vaccination coverage and the numbers of unvaccinated and undervaccinated children as measured by receipt of the first and third doses of diphtheria, tetanus, and pertussis-containing vaccine (DTP) in 2020, when the COVID-19 pandemic began, compared with 2019. Global estimates of coverage with the third dose of DTP (DTP3) and a polio vaccine (Pol3) decreased from 86% in 2019 to 83% in 2020. Similarly, coverage with the first dose of measles-containing vaccine (MCV1) dropped from 86% in 2019 to 84% in 2020. The last year that coverage estimates were at 2020 levels was 2009 for DTP3 and 2014 for both MCV1 and Pol3. Worldwide, 22.7 million children (17% of the target population) were not vaccinated with DTP3 in 2020 compared with 19.0 million (14%) in 2019. Children who did not receive the first DTP dose (DTP1) by age 12 months (zero-dose children) accounted for 95% of the increased number. Among those who did not receive DTP3 in 2020, approximately 17.1 million (75%) were zero-dose children. Global coverage decreased in 2020 compared with 2019 estimates for the completed series of Haemophilus influenzae type b (Hib), hepatitis B vaccine (HepB), human papillomavirus vaccine (HPV), and rubella-containing vaccine (RCV). Full recovery from COVID-19-associated disruptions will require targeted, context-specific strategies to identify and catch up zero-dose and undervaccinated children, introduce interventions to minimize missed vaccinations, monitor coverage, and respond to program setbacks (3).

Survey of women's report for 33 maternal and newborn indicators: EN-BIRTH multi-country validation study.

BACKGROUND: Population-based household surveys, notably the Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS), remain the main source of maternal and newborn health data for many low- and middle-income countries. As part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study, this paper focuses on testing validity of measurement of maternal and newborn indicators around the time of birth (intrapartum and postnatal) in survey-report. METHODS: EN-BIRTH was an observational study testing the validity of measurement for selected maternal and newborn indicators in five secondary/tertiary hospitals in Bangladesh, Nepal and Tanzania, conducted from July 2017 to July 2018. We compared women's report at exit survey with the gold standard of direct observation or verification from clinical records for women with vaginal births. Population-level validity was assessed by validity ratios (survey-reported coverage: observer-assessed coverage). Individual-level accuracy was assessed by sensitivity, specificity and percent agreement. We tested indicators already in DHS/MICS as well as indicators with potential to be included in population-based surveys, notably the first validation for small and sick newborn care indicators. RESULTS: 33 maternal and newborn indicators were evaluated. Amongst nine indicators already present in DHS/MICS, validity ratios for baby dried or wiped, birthweight measured, low birthweight, and sex of baby (female) were between 0.90-1.10. Instrumental birth, skin-to-skin contact, and early initiation of breastfeeding were highly overestimated by survey-report (2.04-4.83) while umbilical cord care indicators were massively underestimated (0.14-0.22). Amongst 24 indicators not currently in DHS/MICS, two newborn contact indicators (kangaroo mother care 1.00, admission to neonatal unit 1.01) had high survey-reported coverage amongst admitted newborns and high sensitivity. The remaining indicators did not perform well and some had very high "don't know" responses. CONCLUSIONS: Our study revealed low validity for collecting many maternal and newborn indicators through an exit survey instrument, even with short recall periods among women with vaginal births. Household surveys are already at risk of overload, and some specific clinical care indicators do not perform well and may be under-powered. Given that approximately 80% of births worldwide occur in facilities, routine registers should also be explored to track coverage of key maternal and newborn health interventions, particularly for clinical care.

Barriers and enablers to routine register data collection for newborns and mothers: EN-BIRTH multi-country validation study.

BACKGROUND: Policymakers need regular high-quality coverage data on care around the time of birth to accelerate progress for ending preventable maternal and newborn deaths and stillbirths. With increasing facility births, routine Health Management Information System (HMIS) data have potential to track coverage. Identifying barriers and enablers faced by frontline health workers recording HMIS source data in registers is important to improve data for use. METHODS: The EN-BIRTH study was a mixed-methods observational study in five hospitals in Bangladesh, Nepal and Tanzania to assess measurement validity for selected Every Newborn coverage indicators. We described data elements required in labour ward registers to track these indicators. To evaluate barriers and enablers for correct recording of data in registers, we designed three interview tools: a) semi-structured in-depth interview (IDI) guide b) semi-structured focus group discussion (FGD) guide, and c) checklist assessing care-to-documentation. We interviewed two groups of respondents (January 2018-March 2019): hospital nurse-midwives and doctors who fill ward registers after birth (n = 40 IDI and n = 5 FGD); and data collectors (n = 65). Qualitative data were analysed thematically by categorising pre-identified codes. Common emerging themes of barriers or enablers across all five hospitals were identified relating to three conceptual framework categories. RESULTS: Similar themes emerged as both barriers and enablers. First, register design was recognised as crucial, yet perceived as complex, and not always standardised for necessary data elements. Second, register filling was performed by over-stretched nurse-midwives with variable training, limited supervision, and availability of logistical resources. Documentation complexity across parallel documents was time-consuming and delayed because of low staff numbers. Complete data were valued more than correct data. Third, use of register data included clinical handover and monthly reporting, but little feedback was given from data users. CONCLUSION: Health workers invest major time recording register data for maternal and newborn core health indicators. Improving data quality requires standardised register designs streamlined to capture only necessary data elements. Consistent implementation processes are also needed. Two-way feedback between HMIS levels is critical to improve performance and accurately track progress towards agreed health goals.

Monitoring climate change and child health: The case for putting children in all policies.

Climate change is threatening the health of current and future generations of children. The most recent evidence from the Lancet Countdown: Tracking Progress on Health and Climate Change finds declining trends in yield potential of major crops, rising heatwave exposures, and increasing climate suitability for the transmission of infectious diseases, putting at risk the health and wellbeing of children around the world. However, if children are considered at the core of planning and implementation, the policy responses to climate change could yield enormous benefits for the health and wellbeing of children throughout their lives. Child health professionals have a role to play in ensuring this, with the beneficiaries of their involvement ranging from the individual child to the global community. The newly established Children in All Policies 2030 initiative will work with the Lancet Countdown to provide the evidence on the climate change responses necessary to protect and promote the health of children.

Progress in adolescent health and wellbeing: tracking 12 headline indicators for 195 countries and territories, 1990-2016.

BACKGROUND: Rapid demographic, epidemiological, and nutritional transitons have brought a pressing need to track progress in adolescent health. Here, we present country-level estimates of 12 headline indicators from the Lancet Commission on adolescent health and wellbeing, from 1990 to 2016. METHODS: Indicators included those of health outcomes (disability-adjusted life-years [DALYs] due to communicable, maternal, and nutritional diseases; injuries; and non-communicable diseases); health risks (tobacco smoking, binge drinking, overweight, and anaemia); and social determinants of health (adolescent fertility; completion of secondary education; not in education, employment, or training [NEET]; child marriage; and demand for contraception satisfied with modern methods). We drew data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2016, International Labour Organisation, household surveys, and the Barro-Lee education dataset. FINDINGS: From 1990 to 2016, remarkable shifts in adolescent health occurred. A decrease in disease burden in many countries has been offset by population growth in countries with the poorest adolescent health profiles. Compared with 1990, an additional 250 million adolescents were living in multi-burden countries in 2016, where they face a heavy and complex burden of disease. The rapidity of nutritional transition is evident from the 324·1 million (18%) of 1·8 billion adolescents globally who were overweight or obese in 2016, an increase of 176·9 million compared with 1990, and the 430·7 million (24%) who had anaemia in 2016, an increase of 74·2 million compared with 1990. Child marriage remains common, with an estimated 66 million women aged 20-24 years married before age 18 years. Although gender-parity in secondary school completion exists globally, prevalence of NEET remains high for young women in multi-burden countries, suggesting few opportunities to enter the workforce in these settings. INTERPRETATION: Although disease burden has fallen in many settings, demographic shifts have heightened global inequalities. Global disease burden has changed little since 1990 and the prevalence of many adolescent health risks have increased. Health, education, and legal systems have not kept pace with shifting adolescent needs and demographic changes. Gender inequity remains a powerful driver of poor adolescent health in many countries. FUNDING: Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation.

Reducing unnecessary caesarean sections: scoping review of financial and regulatory interventions.

BACKGROUND: Caesarean sections (CS) are increasing worldwide. Financial incentives and related regulatory and legislative factors are important determinants of CS rates. This scoping review examines the evidence base of financial, regulatory and legislative interventions intended to reduce CS rates. METHODS: We searched MEDLINE, EMBASE, CINAHL and two trials registers in June 2019. Both experimental and observational intervention studies were eligible for inclusion. Primary outcome measures were: CS, spontaneous vaginal and instrumental birth rates. We assessed quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. RESULTS: We identified 9057 articles and assessed 65 full-texts. We included 16 observational studies. Most of the studies were conducted in high-income countries. Three studies assessed payment methods for health workers: equalising physician fees for vaginal and caesarean delivery reduced CS rates in one study; however, little or no difference in CS rates was found in the remaining two studies. Nine studies assessed payment methods for health organisations: There was no difference in CS rates between diagnosis-related group (DRG) payment system compared to fee-for-service system in one study. However, DRG system was associated with lower odds for CS in another study. There was little or no difference in CS rates following implementation of global budget payment (GBP) system in two studies. Vaginal birth after caesarean section (VBAC) increased after implementation of a case-based payment system in one study. Caesarean section increased while VBAC rates decreased following implementation of a cap-based payment system in another study. Financial incentive for providers to promote vaginal delivery combined with free vaginal delivery policy was found to reduce CS rates in one study. Studied regulatory and legislative interventions (comprising legislatively imposed practice guidelines for physicians in one study and multi-faceted strategy which included policies to control CS on maternal request in another study) were found to reduce CS rates. The GRADE quality of evidence varied from very low to low. CONCLUSIONS: Available evidence on the effects of financial and regulatory strategies intended to reduce unnecessary CS is inconclusive given inconsistency in effects and low quality of the available evidence. More rigorous studies are needed.

Does women's age matter in the SDGs era: coverage of demand for family planning satisfied with modern methods and institutional delivery in 91 low- and middle-income countries.

BACKGROUND: The Sustainable Development Goals (SDGs) include specific targets for family planning (SDG 3.7) and birth attendance (SDG 3.1.2), and require analyses disaggregated by age and other dimensions of inequality (SDG 17.18). We aimed to describe coverage with demand for family planning satisfied with modern methods (DFPSm) and institutional delivery in low- and middle-income countries across the reproductive age spectrum. We attempted to identify a typology of patterns of coverage by age and compare their distribution according to geographic regions, World Bank income groups and intervention coverage levels. METHODS: We used Demographic and Health Survey and Multiple Indicator Cluster Surveys. For DFPSm, we considered the woman's age at the time of the survey, whereas for institutional delivery we considered the woman's age at birth of the child. Both age variables were categorized into seven groups of 5 year-intervals, 15-19 up to 45-49. Five distinct patterns were identified: (a) increasing coverage with age; (b) similar coverage in all age groups; (c) U-shaped; (d) inverse U-shaped; and (e) declining coverage with age. The frequency of the five patterns was examined according to UNICEF regions, World Bank income groups, and coverage at national level of the given indicator. RESULTS: We analyzed 91 countries. For DFPSm, the most frequent age patterns were inverse U-shaped (53%, 47 countries) and increasing coverage with age (41%, 36 countries). Inverse-U shaped patterns for DFPSm was the commonest pattern among lower-middle income countries, while low- and upper middle-income countries showed a more balanced distribution between increasing with age and U-shaped patterns. In the first and second tertiles of national coverage of DFPSm, inverse U-shaped was observed in more than half of countries. For institutional delivery, declining coverage with age was the prevailing pattern (44%, 39 countries), followed by similar coverage across age groups (39%, 35 countries). Most (79%) upper-middle income countries showed no variation by age group while most low-income countries showed declining coverage with age (71%). CONCLUSION: Large inequalities in DFPSm and institutional delivery were identified by age, varying from one intervention to the other. Policy and programmatic approaches must be tailored to national patterns, and in most cases older women and adolescents will require special attention due to lower coverage and because they are at higher risk for maternal mortality and other poor obstetrical outcomes.

Ending preventable maternal mortality: phase II of a multi-step process to develop a monitoring framework, 2016-2030.

BACKGROUND: In February 2015, the World Health Organization (WHO) released "Strategies toward ending preventable maternal mortality (EPMM)" (EPMM Strategies), a direction-setting report outlining global targets and strategies for reducing maternal mortality in the Sustainable Development Goal (SDG) period. In May 2015, the EPMM Working Group outlined a plan to develop a comprehensive monitoring framework to track progress toward the achievement of these targets and priorities. This monitoring framework was developed in two phases. Phase I, which focused on identifying indicators related to the proximal causes of maternal mortality, was completed in October 2015. This paper describes the process and results of Phase II, which was completed in November 2016 and aimed to build consensus on a set of indicators that capture information on the social, political, and economic determinants of maternal health and mortality. FINDINGS: A total of 150 experts from more than 78 organizations worldwide participated in this second phase of the process to develop a comprehensive monitoring framework for EPMM. The experts considered a total of 118 indicators grouped into the 11 key themes outlined in the EPMM report, ultimately reaching consensus on a set of 25 indicators, five equity stratifiers, and one transparency stratifier. CONCLUSION: The indicators identified in Phase II will be used along with the Phase I indicators to monitor progress towards ending preventable maternal deaths. Together, they provide a means for monitoring not only the essential clinical interventions needed to save lives but also the equally important political, social, economic and health system determinants of maternal health and survival. These distal factors are essential to creating the enabling environment and high-performing health systems needed to ensure high-quality clinical care at the point of service for every woman, her fetus and newborn. They complement and support other monitoring efforts, in particular the "Survive, Thrive, and Transform" agenda laid out by the Global Strategy for Women's, Children's and Adolescents' Health (2016-2030) and the SDG3 global target on maternal mortality.

How to assure access of essential RMNCH medicines by looking at policy and systems factors: an analysis of countdown to 2015 countries.

BACKGROUND: In 2000, the Millennium Development Goals set targets for social achievements by 2015 including goals related to maternal and child health, with mixed success. Several initiatives supported these goals including assuring availability of appropriate medicines and commodities to meet health service targets. To reach the new Sustainable Development Goals by 2030, information is needed to address policy and systems factors to improve access to lifesaving commodities. METHODS: We compiled indicator data on 15 commodities related to reproductive, maternal, newborn, and child health (RMNCH) and analyzed them across 75 Countdown to 2015 countries from eight regions to identify problems with specific commodities and determinants of access. The determinants related to policy, regulatory environment, financing, pharmaceutical procurement and supply chain, and information systems. We mapped commodity information from four datasets from the World Health Organization and the United Nation's Commission on Life Saving Commodities creating a stoplight dashboard to illustrate countries' environment to assure access. We also developed a dashboard for policy and systems indicators for select countries. RESULTS: The commodities we identified as having the fewest barriers to access had been in use longer, including oral rehydration solution and oxytocin injection. Looking across the different systems and policy determinants of access, only Zimbabwe had all 15 commodities on both its essential medicines list and in its standard treatment guidelines, and only Cameroon and Zambia had at least one product registered for each commodity. Senegal alone procured all tracer commodities centrally in the previous year, and 70% of responding countries had costed plans for maternal, newborn, and child health. No country reported recent stock-outs of all the 15 commodities at the central level-countries always had some of the 15 commodities available; however, products with frequent stock-outs included misoprostol, calcium gluconate, penicillin injections, ceftriaxone, and amoxicillin dispersible tablets. CONCLUSIONS: This analysis highlights country deficiencies in policies and systems, such as incoherent policy guidelines, problems in product registration, lack of logistics data, and central-level stock-outs that may affect access to essential RMNCH commodities. To tackle these deficiencies, countries need to integrate commodity-related indicators into other health monitoring activities to improve service quality.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Countdown to 2015: a decade of tracking progress for maternal, newborn, and child survival.

Conceived in 2003 and born in 2005 with the launch of its first report and country profiles, the Countdown to 2015 for Maternal, Newborn, and Child Survival has reached its originally proposed lifespan. Major reductions in the deaths of mothers and children have occurred since Countdown's inception, even though most of the 75 priority countries failed to achieve Millennium Development Goals 4 and 5. The coverage of life-saving interventions tracked in Countdown increased steadily over time, but wide inequalities persist between and within countries. Key drivers of coverage such as financing, human resources, commodities, and conducive health policies also showed important, yet insufficient increases. As a multistakeholder initiative of more than 40 academic, international, bilateral, and civil society institutions, Countdown was successful in monitoring progress and raising the visibility of the health of mothers, newborns, and children. Lessons learned from this initiative have direct bearing on monitoring progress during the Sustainable Development Goals era.

Countdown to 2015 and beyond: fulfilling the health agenda for women and children.

The end of 2015 will signal the end of the Millennium Development Goal era, when the world can take stock of what has been achieved. The Countdown to 2015 for Maternal, Newborn, and Child Survival (Countdown) has focused its 2014 report on how much has been achieved in intervention coverage in these groups, and on how best to sustain, focus, and intensify efforts to progress for this and future generations. Our 2014 results show unfinished business in achievement of high, sustained, and equitable coverage of essential interventions. Progress has accelerated in the past decade in most Countdown countries, suggesting that further gains are possible with intensified actions. Some of the greatest coverage gaps are in family planning, interventions addressing newborn mortality, and case management of childhood diseases. Although inequities are pervasive, country successes in reaching of the poorest populations provide lessons for other countries to follow. As we transition to the next set of global goals, we must remember the centrality of data to accountability, and the importance of support of country capacity to collect and use high-quality data on intervention coverage and inequities for decision making. To fulfill the health agenda for women and children both now and beyond 2015 requires continued monitoring of country and global progress; Countdown is committed to playing its part in this effort.