Reclassifying contraceptives as over-the-counter medicines to improve access.

Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is a substantial unmet need for contraception in many countries, increasing access by establishing sound, affordable and effective regulation of over-the-counter contraceptives could help reduce unintended pregnancies and improve maternal health. We performed a review of 30 globally diverse countries: (i) to assess national regulatory procedures for changing oral contraceptives, emergency contraceptives and injectable contraceptives from prescription-only to over-the-counter products; and (ii) to determine whether national lists of over-the-counter medicines included contraceptives. Of the 30 countries, 13 (43%) had formal regulatory procedures in place for changing prescription-only medicines to over-the-counter medicines, 11 (36%) had national lists of over-the-counter medicines, and four (13%) included contraceptives on those lists. Changing from prescription-only to over-the-counter medicines presents challenges for national medicines regulatory authorities and manufacturers, involving, for example, reporting side-effects, quality control and the often poorly-defined process of switching to over-the-counter products. To facilitate the over-the-counter availability of contraceptives, countries should consider adopting a formal regulatory procedure for reclassifying prescription-only contraceptives as over-the-counter contraceptives. Although the availability of over-the-counter contraceptives can increase users' independence and anonymity and improve access, there may also be disadvantages, such as higher out-of-pocket costs and the need for accurate self-assessment. Basic remedial actions to improve, harmonize and standardize regulatory procedures for the reclassification of contraceptives are proposed with the aim of enabling national medicines regulatory authorities to manage the switch to over-the-counter contraceptives and to control their quality.

Les soins autoadministrés incluent les contraceptifs en vente libre, qui permettent aux individus de prendre des décisions réfléchies et autonomes concernant le contrôle de la fécondité. Vu le besoin criant de contraception dans de nombreux pays, faciliter l'accès en proposant des méthodes de régulation sûres, efficaces et abordables par le biais de contraceptifs en vente libre pourrait contribuer à diminuer le nombre de grossesses non désirées et à améliorer la santé maternelle. Nous avons passé en revue 30 pays aux profils variés: (i) pour évaluer les procédures réglementaires nationales visant à modifier le statut des contraceptifs oraux, d'urgence et injectables afin qu'ils soient en vente libre au lieu d'être considérés comme des médicaments sur ordonnance; et (ii) pour déterminer si les contraceptifs figuraient sur les listes nationales de médicaments en vente libre. Sur les 30 pays observés, 13 (43%) avaient mis en place des procédures réglementaires officielles en vue de modifier le statut des contraceptifs, 11 (36%) possédaient des listes nationales de médicaments en vente libre et quatre (13%) y avaient inscrit les contraceptifs. Le passage du statut de médicament sur ordonnance à celui de médicament en vente libre représente un défi pour les autorités nationales de réglementation pharmaceutique et les fabricants, notamment en matière de déclaration des effets secondaires, de contrôle de la qualité et en raison d'un processus souvent mal défini. S'ils souhaitent favoriser la disponibilité des contraceptifs en vente libre, les pays devraient envisager l'adoption d'une procédure réglementaire officielle destinée à reclassifier les contraceptifs sur ordonnance en contraceptifs en vente libre. Bien que cette disponibilité puisse accroître l'autonomie et l'anonymat des usagers et améliorer l'accès à la contraception, elle présente également des désavantages car elle entraîne une hausse des frais non remboursés et requiert une autoévaluation correcte. Le présent document formule des mesures correctrices élémentaires servant à améliorer, harmoniser et normaliser les procédures réglementaires de reclassification des contraceptifs. Objectif: permettre aux autorités nationales de réglementation pharmaceutique de superviser le passage au statut de médicament en vente libre et de contrôler la qualité.

Las intervenciones de cuidado personal incluyen los anticonceptivos de venta libre, que permiten a las personas tomar decisiones informadas y autónomas sobre la gestión de la fertilidad. Dado que en muchos países existe una importante necesidad insatisfecha de anticoncepción, aumentar el acceso mediante el establecimiento de una normativa sólida, asequible y eficaz de los anticonceptivos de venta libre podría ayudar a reducir los embarazos no deseados y mejorar la salud materna. Se realizó una revisión de 30 países de todo el mundo: (i) para evaluar los procedimientos normativos nacionales relativos al cambio de los anticonceptivos orales, los anticonceptivos de urgencia y los anticonceptivos inyectables de medicamentos de venta con receta a productos de venta libre; y (ii) para determinar si las listas nacionales de medicamentos de venta libre incluían los anticonceptivos. De los 30 países, 13 (43 %) contaban con procedimientos normativos formales para el cambio de medicamentos de venta con receta a medicamentos de venta libre, 11 (36 %) tenían listas nacionales de medicamentos de venta libre, y cuatro (13 %) incluían los anticonceptivos en esas listas. El cambio de los medicamentos de venta con receta a los de venta libre supone un desafío para las autoridades nacionales de regulación de medicamentos y para los fabricantes, ya que implica, por ejemplo, la notificación de los efectos secundarios, el control de calidad y el proceso, que suele estar mal definido, de pasar a los productos de venta libre. Para facilitar la disponibilidad de los anticonceptivos sin receta, los países deberían considerar la adopción de un procedimiento normativo formal para reclasificar los anticonceptivos de venta con receta como anticonceptivos de venta sin receta. Aunque la disponibilidad de los anticonceptivos de venta libre puede aumentar la independencia y el anonimato de los usuarios y mejorar el acceso, también puede haber desventajas, como los mayores costos de bolsillo y la necesidad de una autoevaluación precisa. Se proponen acciones correctivas básicas para mejorar, armonizar y estandarizar los procedimientos normativos para la reclasificación de los anticonceptivos, con el objetivo de que las autoridades nacionales de regulación de medicamentos puedan gestionar el cambio a los anticonceptivos sin receta y controlar su calidad.

Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

OBJECTIVE: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care. METHODS: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. CONCLUSION: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014-004445-26. Date of registration 14 August 2014 Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding.

Cost of goods sold analysis and recommendations to reduce costs of co-packaged mifepristone-misoprostol for medical abortion.

OBJECTIVE: Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use. METHODS: We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging. RESULTS: Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer's profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour. CONCLUSIONS: It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard.

How women are treated during facility-based childbirth in four countries: a cross-sectional study with labour observations and community-based surveys.

BACKGROUND: Women across the world are mistreated during childbirth. We aimed to develop and implement evidence-informed, validated tools to measure mistreatment during childbirth, and report results from a cross-sectional study in four low-income and middle-income countries. METHODS: We prospectively recruited women aged at least 15 years in twelve health facilities (three per country) in Ghana, Guinea, Myanmar, and Nigeria between Sept 19, 2016, and Jan 18, 2018. Continuous observations of labour and childbirth were done from admission up to 2 h post partum. Surveys were administered by interviewers in the community to women up to 8 weeks post partum. Labour observations were not done in Myanmar. Data were collected on sociodemographics, obstetric history, and experiences of mistreatment. FINDINGS: 2016 labour observations and 2672 surveys were done. 838 (41·6%) of 2016 observed women and 945 (35·4%) of 2672 surveyed women experienced physical or verbal abuse, or stigma or discrimination. Physical and verbal abuse peaked 30 min before birth until 15 min after birth (observation). Many women did not consent for episiotomy (observation: 190 [75·1%] of 253; survey: 295 [56·1%] of 526) or caesarean section (observation: 35 [13·4%] of 261; survey: 52 [10·8%] of 483), despite receiving these procedures. 133 (5·0%) of 2672 women or their babies were detained in the facility because they were unable to pay the bill (survey). Younger age (15-19 years) and lack of education were the primary determinants of mistreatment (survey). For example, younger women with no education (odds ratio [OR] 3·6, 95% CI 1·6-8·0) and younger women with some education (OR 1·6, 1·1-2·3) were more likely to experience verbal abuse, compared with older women (≥30 years), adjusting for marital status and parity. INTERPRETATION: More than a third of women experienced mistreatment and were particularly vulnerable around the time of birth. Women who were younger and less educated were most at risk, suggesting inequalities in how women are treated during childbirth. Understanding drivers and structural dimensions of mistreatment, including gender and social inequalities, is essential to ensure that interventions adequately account for the broader context. FUNDING: United States Agency for International Development and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO.

Global inequities in dietary calcium intake during pregnancy: a systematic review and meta-analysis.

BACKGROUND: Evidence shows that adequate calcium intake during pregnancy reduces the risk of hypertensive disorders of pregnancy. In most low- and middle-income countries (LMICs) the daily calcium intake is well below recommendations. Mapping calcium intake during pregnancy worldwide and identifying populations with low calcium intake will provide the evidence base for more targeted actions to improve calcium intake. OBJECTIVE: To assess dietary calcium intake during pregnancy worldwide. SEARCH STRATEGY: MEDLINE and EMBASE (from July 2004 to November 2017). SELECTION CRITERIA: Cross-sectional, cohort, and intervention studies reporting calcium intake during pregnancy. DATA COLLECTION AND ANALYSIS: Five reviewers working in pairs independently performed screening, extraction, and quality assessment. We reported summary measures of calcium intake and calculated the weighted arithmetic mean for high-income countries (HICs) and LMICs independently, and for geographic regions, among studies reporting country of recruitment, mean intake, and total number of participants. When available, inadequate intakes were reported. MAIN RESULTS: From 1880 citations 105 works met the inclusion criteria, providing data for 73 958 women in 37 countries. The mean calcium intake was 948.3 mg/day (95% CI 872.1-1024.4 mg/day) for HICs and 647.6 mg/day (95% CI 568.7-726.5 mg/day) for LMICs. Calcium intakes below 800 mg/day were reported in five (29%) countries from HICs and in 14 (82%) countries from LMICs. CONCLUSION: These results are consistent with a lack of improvement in calcium dietary intake during pregnancy and confirm the gap between HICs and LMICs, with alarmingly low intakes recorded for pregnant women in LMICs. From the public health perspective, in the absence of specific local data, calcium supplementation of pregnant women in these countries should be universal. TWEETABLE ABSTRACT: Despite dietary recommendations, women in LMICs face pregnancy with diets low in calcium.

Methodological development of tools to measure how women are treated during facility-based childbirth in four countries: labor observation and community survey.

BACKGROUND: Efforts to improve maternal health are increasingly focused on improving the quality of care provided to women at health facilities, including the promotion of respectful care and eliminating mistreatment of women during childbirth. A WHO-led multi-country research project aims to develop and validate two tools (labor observation and community survey) to measure how women are treated during facility-based childbirth. This paper describes the development process for these measurement tools, and how they were implemented in a multi-country study (Ghana, Guinea, Myanmar and Nigeria). METHODS: An iterative mixed-methods approach was used to develop two measurement tools. Methodological development was conducted in four steps: (1) initial tool development; (2) validity testing, item adjustment and piloting of paper-based tools; (3) conversion to digital, tablet-based tools; and (4) data collection and analysis. These steps included systematic reviews, primary qualitative research, mapping of existing tools, item consolidation, peer review by key stakeholders and piloting. RESULTS: The development, structure, administration format, and implementation of the labor observation and community survey tools are described. For the labor observations, a total of 2016 women participated: 408 in Nigeria, 682 in Guinea, and 926 in Ghana. For the community survey, a total of 2672 women participated: 561 in Nigeria, 644 in Guinea, 836 in Ghana, and 631 in Myanmar. Of the 2016 women who participated in the labor observations, 1536 women (76.2%) also participated in the community survey and have linked data: 779 in Ghana, 425 in Guinea, and 332 in Nigeria. CONCLUSIONS: An important step to improve the quality of maternity care is to understand the magnitude and burden of mistreatment across contexts. Researchers and healthcare providers in maternal health are encouraged to use and implement these tools, to inform the development of more women-centered, respectful maternity healthcare services. By measuring the prevalence of mistreatment of women during childbirth, we will be able to design and implement programs and policies to transform maternity services.

What matters to women during childbirth: A systematic qualitative review.

INTRODUCTION: Design and provision of good quality maternity care should incorporate what matters to childbearing women. This qualitative systematic review was undertaken to inform WHO intrapartum guidelines. METHODS: Using a pre-determined search strategy, we searched Medline, CINAHL, PsycINFO, AMED, EMBASE, LILACS, AJOL, and reference lists of eligible studies published 1996-August 2016 (updated to January 2018), reporting qualitative data on womens' childbirth beliefs, expectations, and values. Studies including specific interventions or health conditions were excluded. PRISMA guidelines were followed. DATA COLLECTION AND ANALYSIS: Authors' findings were extracted, logged on a study-specific data form, and synthesised using meta-ethnographic techniques. Confidence in the quality, coherence, relevance and adequacy of data underpinning the resulting themes was assessed using GRADE-CERQual. A line of argument synthesis was developed. RESULTS: 35 studies (19 countries) were included in the primary search, and 2 in the update. Confidence in most results was moderate to high. What mattered to most women was a positive experience that fulfilled or exceeded their prior personal and socio-cultural beliefs and expectations. This included giving birth to a healthy baby in a clinically and psychologically safe environment with practical and emotional support from birth companions, and competent, reassuring, kind clinical staff. Most wanted a physiological labour and birth, while acknowledging that birth can be unpredictable and frightening, and that they may need to 'go with the flow'. If intervention was needed or wanted, women wanted to retain a sense of personal achievement and control through active decision-making. These values and expectations were mediated through womens' embodied (physical and psychosocial) experience of pregnancy and birth; local familial and sociocultural norms; and encounters with local maternity services and staff. CONCLUSIONS: Most healthy childbearing women want a positive birth experience. Safety and psychosocial wellbeing are equally valued. Maternity care should be designed to fulfil or exceed womens' personal and socio-cultural beliefs and expectations.

Evaluating implementation of the World Health Organization's Strategic Approach to strengthening sexual and reproductive health policies and programs to address unintended pregnancy and unsafe abortion.

BACKGROUND: We conducted a process evaluation to assess how the World Health Organization's (WHO) Strategic Approach to strengthening sexual and reproductive health policies and programs ("the SA") was used in 15 countries that requested WHO's technical support in addressing unintended pregnancy and unsafe abortion. The SA is a three-stage planning, policy, and program implementation process. We used the social ecological model (SEM) to analyze the contextual factors that influenced SA implementation. METHODS: We used a two-phased sequential approach to data collection and analysis. In Phase A, we conducted a document and literature review and synthesized data thematically. In Phase B, we conducted interviews with stakeholders who used the SA in the countries of interest. We used a qualitative method triangulation technique to analyze and combine data from both phases to understand how the SA was implemented in each country. RESULTS: Data from 145 documents and 19 interviews described the SA process and activities in each country. All 15 countries completed Stage 1 activities. The activities of Stage 1 determined activities in subsequent stages and varied across countries. Following Stage 1, some countries focused on reforming policies to improve access to sexual and reproductive health (SRH) services whereas others focused on improving provider-level capacity to enhance SRH service quality and improving community-level SRH education. We identified factors across SEM levels that affected SA implementation, including individual- and community-level perceptions of using the SA and the recommendations that emerged from its use, organizational capacity to conduct SA activities, and how well these activities aligned with the existing political climate. Stakeholders perceived SA implementation to be country-driven and systematic in bringing attention to important SRH issues in their countries. CONCLUSION: We identified key success factors for influencing the individual, organization, and system change required for implementing the SA. These include sustaining stakeholder engagement for all SA stages, monitoring and reporting on activities, and leveraging activities and outputs from each SA stage to obtain technical and financial support for subsequent stages. Results may be used to optimize ongoing implementation efforts to improve access to and the quality of SRH services.

Mistreatment of women during childbirth in Abuja, Nigeria: a qualitative study on perceptions and experiences of women and healthcare providers.

BACKGROUND: Global efforts have increased facility-based childbirth, but substantial barriers remain in some settings. In Nigeria, women report that poor provider attitudes influence their use of maternal health services. Evidence also suggests that women in Nigeria may experience mistreatment during childbirth; however, there is limited understanding of how and why mistreatment this occurs. This study uses qualitative methods to explore women and providers' experiences and perceptions of mistreatment during childbirth in two health facilities and catchment areas in Abuja, Nigeria. METHODS: In-depth interviews (IDIs) and focus group discussions (FGDs) were used with a purposive sample of women of reproductive age, midwives, doctors and facility administrators. Instruments were semi-structured discussion guides. Participants were asked about their experiences and perceptions of, and perceived factors influencing mistreatment during childbirth. Thematic analysis was used to synthesize findings into meaningful sub-themes, narrative text and illustrative quotations, which were interpreted within the context of this study and an existing typology of mistreatment during childbirth. RESULTS: Women and providers reported experiencing or witnessing physical abuse including slapping, physical restraint to a delivery bed, and detainment in the hospital and verbal abuse, such as shouting and threatening women with physical abuse. Women sometimes overcame tremendous barriers to reach a hospital, only to give birth on the floor, unattended by a provider. Participants identified three main factors contributing to mistreatment: poor provider attitudes, women's behavior, and health systems constraints. CONCLUSIONS: Moving forward, findings from this study must be communicated to key stakeholders at the study facilities. Measurement tools to assess how often mistreatment occurs and in what manner must be developed for monitoring and evaluation. Any intervention to prevent mistreatment will need to be multifaceted, and implementers should consider lessons learned from related interventions, such as increasing audit and feedback including from women, promoting labor companionship and encouraging stress-coping training for providers.

Classification systems for causes of stillbirth and neonatal death, 2009-2014: an assessment of alignment with characteristics for an effective global system.

BACKGROUND: To reduce the burden of 5.3 million stillbirths and neonatal deaths annually, an understanding of causes of deaths is critical. A systematic review identified 81 systems for classification of causes of stillbirth (SB) and neonatal death (NND) between 2009 and 2014. The large number of systems hampers efforts to understand and prevent these deaths. This study aimed to assess the alignment of current classification systems with expert-identified characteristics for a globally effective classification system. METHODS: Eighty-one classification systems were assessed for alignment with 17 characteristics previously identified through expert consensus as necessary for an effective global system. Data were extracted independently by two authors. Systems were assessed against each characteristic and weighted and unweighted scores assigned to each. Subgroup analyses were undertaken by system use, setting, type of death included and type of characteristic. RESULTS: None of the 81 systems were aligned with more than 9 of the 17 characteristics; most (82 %) were aligned with four or fewer. On average, systems were aligned with 19 % of characteristics. The most aligned system (Frøen 2009-Codac) still had an unweighted score of only 9/17. Alignment with individual characteristics ranged from 0 to 49 %. Alignment was somewhat higher for widely used as compared to less used systems (22 % v 17 %), systems used only in high income countries as compared to only in low and middle income countries (20 % vs 16 %), and systems including both SB and NND (23 %) as compared to NND-only (15 %) and SB-only systems (13 %). Alignment was higher with characteristics assessing structure (23 %) than function (15 %). CONCLUSIONS: There is an unmet need for a system exhibiting all the characteristics of a globally effective system as defined by experts in the use of systems, as none of the 81 contemporary classification systems assessed was highly aligned with these characteristics. A particular concern in terms of global effectiveness is the lack of alignment with "ease of use" among all systems, including even the most-aligned. A system which meets the needs of users would have the potential to become the first truly globally effective classification system.

Association between rates of caesarean section and maternal and neonatal mortality in the 21st century: a worldwide population-based ecological study with longitudinal data.

OBJECTIVE: Caesarean section was initially performed to save the lives of the mother and/or her baby. Caesarean section rates have risen substantially worldwide over the past decades. In this study, we set out to compile all available caesarean section rates worldwide at the country level, and to identify the appropriate caesarean section rate at the population level associated with the minimal maternal and neonatal mortality. DESIGN: Ecological study using longitudinal data. SETTING: Worldwide country-level data. POPULATION: A total of 159 countries were included in the analyses, representing 98.0% of global live births (2005). METHODS: Nationally representative caesarean section rates from 2000 to 2012 were compiled. We assessed the relationship between caesarean section rates and mortality outcomes, adjusting for socio-economic development by means of human development index (HDI) using fractional polynomial regression models. MAIN OUTCOME MEASURES: Maternal mortality ratio and neonatal mortality rate. RESULTS: Most countries have experienced increases in caesarean section rate during the study period. In the unadjusted analysis, there was a negative association between caesarean section rates and mortality outcomes for low caesarean section rates, especially among the least developed countries. After adjusting for HDI, this effect was much smaller and was only observed below a caesarean section rate of 5-10%. No important association between the caesarean section rate and maternal and neonatal mortality was observed when the caesarean section rate exceeded 10%. CONCLUSIONS: Although caesarean section is an effective intervention to save maternal and infant lives, based on the available ecological evidence, caesarean section rates higher than around 10% at the population level are not associated with decreases in maternal and neonatal mortality rates, and thus may not be necessary to achieve the lowest maternal and neonatal mortality. TWEETABLE ABSTRACT: The caesarean section rate of around 10% may be the optimal rate to achieve the lowest mortality.

"By slapping their laps, the patient will know that you truly care for her": A qualitative study on social norms and acceptability of the mistreatment of women during childbirth in Abuja, Nigeria.

BACKGROUND: Many women experience mistreatment during childbirth in health facilities across the world. However, limited evidence exists on how social norms and attitudes of both women and providers influence mistreatment during childbirth. Contextually-specific evidence is needed to understand how normative factors affect how women are treated. This paper explores the acceptability of four scenarios of mistreatment during childbirth. METHODS: Two facilities were identified in Abuja, Nigeria. Qualitative methods (in-depth interviews (IDIs) and focus group discussions (FGDs)) were used with a purposive sample of women, midwives, doctors and administrators. Participants were presented with four scenarios of mistreatment during childbirth: slapping, verbal abuse, refusing to help the woman and physical restraint. Thematic analysis was used to synthesize findings, which were interpreted within the study context and an existing typology of mistreatment during childbirth. RESULTS: Eighty-four IDIs and 4 FGDs are included in this analysis. Participants reported witnessing and experiencing mistreatment during childbirth, including slapping, physical restraint to a delivery bed, shouting, intimidation, and threats of physical abuse or poor health outcomes. Some women and providers considered each of the four scenarios as mistreatment. Others viewed these scenarios as appropriate and acceptable measures to gain compliance from the woman and ensure a good outcome for the baby. Women and providers blamed a woman's "disobedience" and "uncooperativeness" during labor for her experience of mistreatment. CONCLUSIONS: Blaming women for mistreatment parallels the intimate partner violence literature, demonstrating how traditional practices and low status of women potentiate gender inequality. These findings can be used to facilitate dialogue in Nigeria by engaging stakeholders to discuss how to challenge these norms and hold providers accountable for their actions. Until women and their families are able to freely condemn poor quality care in facilities and providers are held accountable for their actions, there will be little incentive to foster change.

Scaling up quality care for mothers and newborns around the time of birth: an overview of methods and analyses of intervention-specific bottlenecks and solutions.

BACKGROUND: The Every Newborn Action Plan (ENAP) and Ending Preventable Maternal Mortality targets cannot be achieved without high quality, equitable coverage of interventions at and around the time of birth. This paper provides an overview of the methodology and findings of a nine paper series of in-depth analyses which focus on the specific challenges to scaling up high-impact interventions and improving quality of care for mothers and newborns around the time of birth, including babies born small and sick. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the ENAP process. Country workshops engaged technical experts to complete a tool designed to synthesise "bottlenecks" hindering the scale up of maternal-newborn intervention packages across seven health system building blocks. We used quantitative and qualitative methods and literature review to analyse the data and present priority actions relevant to different health system building blocks for skilled birth attendance, emergency obstetric care, antenatal corticosteroids (ACS), basic newborn care, kangaroo mother care (KMC), treatment of neonatal infections and inpatient care of small and sick newborns. RESULTS: The 12 countries included in our analysis account for the majority of global maternal (48%) and newborn (58%) deaths and stillbirths (57%). Our findings confirm previously published results that the interventions with the most perceived bottlenecks are facility-based where rapid emergency care is needed, notably inpatient care of small and sick newborns, ACS, treatment of neonatal infections and KMC. Health systems building blocks with the highest rated bottlenecks varied for different interventions. Attention needs to be paid to the context specific bottlenecks for each intervention to scale up quality care. Crosscutting findings on health information gaps inform two final papers on a roadmap for improvement of coverage data for newborns and indicate the need for leadership for effective audit systems. CONCLUSIONS: Achieving the Sustainable Development Goal targets for ending preventable mortality and provision of universal health coverage will require large-scale approaches to improving quality of care. These analyses inform the development of systematic, targeted approaches to strengthening of health systems, with a focus on overcoming specific bottlenecks for the highest impact interventions.

Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth complications are the leading cause of deaths for children under five years. Antenatal corticosteroids (ACS) are effective at reducing mortality and serious morbidity amongst infants born at <34 weeks gestation. WHO guidelines strongly recommend use of ACS for women at risk of imminent preterm birth where gestational age, imminent preterm birth, and risk of maternal infection can be assessed, and appropriate maternal/newborn care provided. However, coverage remains low in high-burden countries for reasons not previously systematically investigated. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for ACS. RESULTS: Eleven out of twelve countries provided data in response to the ACS questionnaire. Health system building blocks most frequently reported as having significant or very major bottlenecks were health information systems (11 countries), essential medical products and technologies (9 out of 11 countries) and health service delivery (9 out of 11 countries). Bottlenecks included absence of coverage data, poor gestational age metrics, lack of national essential medicines listing, discrepancies between prescribing authority and provider cadres managing care, delays due to referral, and lack of supervision, mentoring and quality improvement systems. CONCLUSIONS: Analysis centred on health system building blocks in which 9 or more countries (>75%) reported very major or significant bottlenecks. Health information systems should include improved gestational age assessment and track ACS coverage, use and outcomes. Better health service delivery requires clarified policy assigning roles by level of care and cadre of provider, dependent on capability to assess gestational age and risk of preterm birth, and the implementation of guidelines with adequate supervision, mentoring and quality improvement systems, including audit and feedback. National essential medicines lists should include dexamethasone for antenatal use, and dexamethasone should be integrated into supply logistics.

Count every newborn; a measurement improvement roadmap for coverage data.

BACKGROUND: The Every Newborn Action Plan (ENAP), launched in 2014, aims to end preventable newborn deaths and stillbirths, with national targets of ≤12 neonatal deaths per 1000 live births and ≤12 stillbirths per 1000 total births by 2030. This requires ambitious improvement of the data on care at birth and of small and sick newborns, particularly to track coverage, quality and equity. METHODS: In a multistage process, a matrix of 70 indicators were assessed by the Every Newborn steering group. Indicators were graded based on their availability and importance to ENAP, resulting in 10 core and 10 additional indicators. A consultation process was undertaken to assess the status of each ENAP core indicator definition, data availability and measurement feasibility. Coverage indicators for the specific ENAP treatment interventions were assigned task teams and given priority as they were identified as requiring the most technical work. Consultations were held throughout. RESULTS: ENAP published 10 core indicators plus 10 additional indicators. Three core impact indicators (neonatal mortality rate, maternal mortality ratio, stillbirth rate) are well defined, with future efforts needed to focus on improving data quantity and quality. Three core indicators on coverage of care for all mothers and newborns (intrapartum/skilled birth attendance, early postnatal care, essential newborn care) have defined contact points, but gaps exist in measuring content and quality of the interventions. Four core (antenatal corticosteroids, neonatal resuscitation, treatment of serious neonatal infections, kangaroo mother care) and one additional coverage indicator for newborns at risk or with complications (chlorhexidine cord cleansing) lack indicator definitions or data, especially for denominators (population in need). To address these gaps, feasible coverage indicator definitions are presented for validity testing. Measurable process indicators to help monitor health service readiness are also presented. A major measurement gap exists to monitor care of small and sick babies, yet signal functions could be tracked similarly to emergency obstetric care. CONCLUSIONS: The ENAP Measurement Improvement Roadmap (2015-2020) outlines tools to be developed (e.g., improved birth and death registration, audit, and minimum perinatal dataset) and actions to test, validate and institutionalise proposed coverage indicators. The roadmap presents a unique opportunity to strengthen routine health information systems, crosslinking these data with civil registration and vital statistics and population-based surveys. Real measurement change requires intentional transfer of leadership to countries with the greatest disease burden and will be achieved by working with centres of excellence and existing networks.

Facilitators and barriers to facility-based delivery in low- and middle-income countries: a qualitative evidence synthesis.

High-quality obstetric delivery in a health facility reduces maternal and perinatal morbidity and mortality. This systematic review synthesizes qualitative evidence related to the facilitators and barriers to delivering at health facilities in low- and middle-income countries. We aim to provide a useful framework for better understanding how various factors influence the decision-making process and the ultimate location of delivery at a facility or elsewhere. We conducted a qualitative evidence synthesis using a thematic analysis. Searches were conducted in PubMed, CINAHL and gray literature databases. Study quality was evaluated using the CASP checklist. The confidence in the findings was assessed using the CERQual method. Thirty-four studies from 17 countries were included. Findings were organized under four broad themes: (1) perceptions of pregnancy and childbirth; (2) influence of sociocultural context and care experiences; (3) resource availability and access; (4) perceptions of quality of care. Key barriers to facility-based delivery include traditional and familial influences, distance to the facility, cost of delivery, and low perceived quality of care and fear of discrimination during facility-based delivery. The emphasis placed on increasing facility-based deliveries by public health entities has led women and their families to believe that childbirth has become medicalized and dehumanized. When faced with the prospect of facility birth, women in low- and middle-income countries may fear various undesirable procedures, and may prefer to deliver at home with a traditional birth attendant. Given the abundant reports of disrespectful and abusive obstetric care highlighted by this synthesis, future research should focus on achieving respectful, non-abusive, and high-quality obstetric care for all women. Funding for this project was provided by The United States Agency for International Development (USAID) and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization.