Pregnancy in the Context of Urbanicity and Climate Change. The Overall Aim of the Project is to Co-create, Implement, and Test New Clinical Guidelines in Order to Improve the Quality of Care in Antenatal Clinics in the Context of Urbanisation and Climate Change in Dar es Salaam, Tanzania.

The PartoMa ANC study is a district-wide, mixed-methods implementation study designed to co-create, implement, and evaluate a context-tailored antenatal care (ANC) quality improvement intervention in Temeke District, Dar es Salaam, Tanzania. The study is grounded in the premise that pregnancy care in rapidly urbanizing, climate-vulnerable settings is shaped not only by clinical practice, but also by interacting social, environmental, and health-system constraints.

The intervention extends prior PartoMa work in childbirth care by shifting the focus upstream to ANC, with the aim of strengthening prevention, early detection, and initial management of pregnancy-related complications within routine public-sector services. The study is situated in the governmental health sector of Temeke District, which includes 21 facilities providing ANC, including facilties which also provide gynecological and childbirth care.

The scientific rationale for the study is that climate change, urbanization, and sexual and reproductive health and rights are closely interconnected, yet ANC models in low-resource urban settings rarely account for these interacting pressures. In Dar es Salaam, rapid population growth, unplanned settlement patterns, environmental hazards, and overstretched health services may contribute to poor pregnancy care experiences and adverse maternal and perinatal outcomes despite high contact with ANC services.

The protocol further builds on findings from the ongoing PartoMa studies suggesting persistent gaps in antenatal risk detection, birth preparedness, and management of untreated pregnancy complications. The present study therefore seeks to generate evidence on how a locally adapted ANC intervention can be embedded in routine care in a way that is feasible, acceptable, and responsive to the realities of a congested urban health system.

The intervention is informed by an explicit programme theory and by conceptual frameworks drawn from Complex Adaptive Systems and social practice theory. Within this framework, ANC is understood as a dynamic system in which women, families, providers, facilities, referral pathways, and wider contextual influences interact in non-linear ways. The study hypothesizes that intervention effects will arise through multiple linked mechanisms, including improved provider learning and decision-making, improved uptake and integration of ANC guidance into existing practice, and greater alignment between care content and the needs, preferences, and lived realities of pregnant women. This theory-driven approach is intended not only to assess whether the intervention works, but also to understand how and under what contextual conditions it may be implementable and scalable.

The study is organized into four interlinked work packages

1. The first work package is a situational analysis designed to characterize barriers and facilitators affecting the receipt and provision of ANC in this setting. This phase uses interdisciplinary mixed methods to examine structural conditions in ANC clinics, care processes across the antenatal and referral pathway, and the experiences of women and providers. Quantitative activities include facility assessments, mapping of current ANC guidance in use, structured exit interviews following ANC visits, and reviews of antenatal, gynecological, and birth-related records. The qualitative component includes participatory follow-up of women during pregnancy, documentation of care journeys inside and outside the health system, observations, in-depth interviews, and participatory approaches such as Photo Voice. These data are intended to inform both intervention design and interpretation of implementation effects. 2. The second work package focuses on co-creation of the intervention and its implementation strategy. Two synergistic versions of ANC guidance will be developed: one for pregnant women and their partners or families, and one for health providers. Both versions are expected to address routine pregnancy care, early-pregnancy complications, and complications later in pregnancy, while remaining adaptable to locally identified priorities. Co-creation will involve iterative engagement with women, providers, health-system leaders, and policymakers through repeated focus group discussions and other participatory activities. The research team will synthesize these inputs into guidance materials and associated training content, which will then undergo expert review. An embedded ethnographic component will examine how co-creators influence, experience, and shape the intervention development process. 3. The implementation phase will introduce the intervention across all eligible government facilities in Temeke District using a pre-post comparison design. Planned implementation strategies include training selected facilitators who, together with the research team, will support recurring training sessions for healthcare providers, drawing on or integrating with the existing PartoMa training structure. Women attending ANC will receive a booklet version of the guidance, and an mHealth component will supplement in-person care through health- and visit-related text messaging. Because the intervention is delivered at district scale and within routine services, the study is designed to evaluate effectiveness under real-world conditions rather than under tightly controlled experimental conditions.

Evaluation is structured along the proposed causal pathway from intervention exposure to provider learning, service delivery processes, and pregnancy-related endpoints recorded elsewhere in the study record. Pre-intervention measurements generated during the situational analysis will serve as the main baseline, supplemented by an additional baseline period immediately preceding implementation for routinely collected pregnancy outcome data. Post-implementation assessment will draw on multiple complementary data sources, including criterion-based audits of antenatal cards and case files, hospital registers, medical records, structured interviews, and other participant-level and facility-level documentation collected by trained research assistants. Quantitative analyses are planned primarily as comparisons of pre- and post-implementation measures, with stratified and adjusted analyses undertaken when relevant. Qualitative analyses will be used to interpret implementation processes, user experiences, contextual influences, and mechanisms of change. 4. A final work package will synthesize findings relevant to sustainability and scale-up. This phase will examine which contextual conditions and intervention features appear important for sustaining positive changes and for adapting the model to other urban settings. Particular attention will be paid to methodological lessons, delivery processes, and the implications of implementing a complex intervention in routine care environments. The protocol also indicates that recommendations for future research and practice, including a plan for subsequent cost-effectiveness assessment, will be developed if the intervention demonstrates promise.

The study will be conducted in accordance with the Declaration of Helsinki, with ethics approvals sought in Tanzania and informed consent obtained from women and health providers participating in primary data collection activities.

• Preterm births. [Срок оценки: At birth.]
• Uncomplicated postabortion care. [Срок оценки: Until 28 weeks gestational age.]