Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to meet the Sustainable Development Goals. South Asia and sub-Saharan Africa bear most of the burden of maternal and child morbidity and mortality. Major gaps persist in our understanding of the causes, timing, diagnostic thresholds and risk factors for adverse outcomes in these regions. Addressing these gaps requires new ways to prevent and treat disease, from novel diagnostics to precision public health strategies, all of which rely on high-quality clinical data from diverse populations. The Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study aims to estimate population-level prevalence of morbidities and mortality and to assess biological, clinical and sociodemographic risk among mother–infant pairs in India, Pakistan, Kenya, Ghana and Zambia.

This study is a prospective, open cohort study with a planned recruitment of about 6000 women annually across six research sites in five countries. Participants are pregnant women enrolled less than 20 weeks gestation, as determined by ultrasound, identified through active house-to-house and facility-based surveillance. Robust clinical data will be collected at 12 scheduled study visits during antenatal care, labour and delivery, and through 1 year postpartum. A total of 34 outcomes will be captured. The primary analysis will estimate the burden of adverse outcomes and examine associated risk factors to inform future intervention strategies. Data will also be used to develop normative values for pregnant and postpartum women, as well as predictive models to assess pregnancy risk.

PRISMA received institutional and national ethical approvals. Findings will be published in peer-reviewed open-access journals and disseminated at national and international forums to inform clinical guidelines and public health practice.

NCT05904145.

The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.

This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.

Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022–17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.

Clinical Trials Registry – India, CTRI/2021/03/031622.