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BACKGROUND: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. METHODS/DESIGN: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up).

BACKGROUND: Most complications during labour and childbirth could be averted with timely interventions by skilled healthcare providers. Yet, the quality and outcomes of childbirth care remains suboptimal in many health facilities in low-resource settings. To accelerate the reduction of childbirth-related maternal, fetal and newborn mortality and morbidity, the World Health Organization has initiated the "Better Outcomes in Labour Difficulty" (BOLD) project to address weaknesses in labour care processes and better connect health systems and communities. The project seeks to develop a "Simplified, Effective, Labour Monitoring-to-Action" tool (SELMA) to assist healthcare providers to monitor labour and take decisive actions more efficiently; and by developing an innovative set of service prototypes and/or tools termed "Passport to Safer Birth", designed with communities and healthcare providers, to promote access to quality care for women during childbirth. This protocol describes the formative research activities to support the development of these tools. METHODS/DESIGN: We will employ qualitative research and service design methodologies in eight health facilities and their catchment communities in Nigeria and Uganda. In the health facilities, focus group discussions (FGD) and in-depth interviews (IDI) will be conducted among different cadres of healthcare providers and facility administrators. In the communities, FGDs and IDIs will be conducted among women who have delivered in a health facility. We will use service design methods to explore women's journey to access and receive childbirth care in order to innovate and design services around the needs and expectations of women, within the context of the health system. DISCUSSION: This formative research will serve several roles. First, it will provide an in-depth understanding of healthcare providers and health system issues to be accounted for in the final design and implementation of SELMA. Second, it will help to

As most pregnancy-related deaths and morbidities are clustered around the time of childbirth, quality of care during this period is critical to the survival of pregnant women and their babies. Despite the wide acceptance of partograph as the central tool to optimize labour outcomes for over 40 years, its use has not successfully improved outcomes in many settings for several reasons. There are also increasing questions about the validity and applicability of its central feature - "the alert line" - to all women regardless of their labour characteristics. Apart from the known deficiencies in labour care, attempts to improve quality of care in low resource settings have also failed to address and integrate women's birth experience into quality improvement processes. It was against this background that the World Health Organization (WHO) embarked on the Better Outcomes in Labour Difficulty (BOLD) project to improve the quality of intrapartum care in low- and middle-income countries. The main goal of the BOLD project is to reduce intrapartum-related stillbirths, maternal and newborn mortalities and morbidities by addressing the critical barriers to the process of good quality intrapartum care and enhancing the connection between health systems and communities. The project seeks to achieve this goal by (1) developing an evidence-based, easy to use, labour monitoring-to-action decision-support tool (currently termed Simplified, Effective, Labour Monitoring-to-Action - SELMA); and (2) by developing innovative service prototypes/tools, co-designed with users of health services (women, their families and communities) and health providers, to promote access to respectful, dignified and emotionally supportive care for pregnant women and their companions at the time of birth ("Passport to Safer Birth"). This two-pronged approach is expected to positively impact on important domains of quality of care relating to both provision and experience of care. In this paper, we briefly d

BACKGROUND: Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required. METHODS: We adapted the methods of the Child Health and Nutrition Research Initiative (CHNRI) to identify and set global research priorities for maternal and perinatal health for the period 2015 to 2025. Priority research questions were received from various international stakeholders constituting a large reference group, and consolidated into a final list of research questions by a technical working group. Questions on this list were then scored by the reference working group according to five independent and equally weighted criteria. Normalized research priority scores (NRPS) were calculated, and research priority questions were ranked accordingly. RESULTS: A list of 190 priority research questions for improving maternal and perinatal health was scored by 140 stakeholders. Most priority research questions (89%) were concerned with the evaluation of implementation and delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. CONCLUSIONS: Key research priorities in maternal and perinatal health were identified. The resulting ranked list of research questions provides a valuable resource for health research investors, researchers and other stakeholders. We are hopeful that this exercise will inform the post-2015 Development Agenda and assist donors, research-policy decision makers and researchers to invest in research that will ultimately make the most sig