To end the international crisis of preventable deaths in low-income and middle-income countries, evidence-informed and cost-efficient health care is urgently needed, and contextualised clinical practice guidelines are pivotal. However, as exposed by indirect consequences of poorly adapted COVID-19 guidelines, fundamental gaps continue to be reported between international recommendations and realistic best practice. To address this long-standing injustice of leaving health providers without useful guidance, we draw on examples from maternal health and the COVID-19 pandemic. We propose a framework for how global guideline developers can more effectively stratify recommendations for low-resource settings and account for predictable contextual barriers of implementation (eg, human resources) as well as gains and losses (eg, cost-efficiency). Such development of more realistic clinical practice guidelines at the global level will pave the way for simpler and achievable adaptation at local levels. We also urge the development and adaptation of high-quality clinical practice guidelines at national and subnational levels in low-income and middle-income countries through co-creation with end-users, and we encourage global sharing of these experiences.

Despite its worldwide use, reviews of oxytocin for labor augmentation include mainly studies from high-income countries. Meanwhile, oxytocin is a potentially harmful medication and risks may be higher in low-resource settings. We conducted a systematic review and meta-analysis of practices, benefits, and risks of oxytocin for labor augmentation in low- and lower-middle-income countries. PubMed, Embase, PsycINFO, Index Medicus, Cochrane, and Google Scholar were searched for publications until January 1, 2022. All studies evaluating oxytocin augmentation rates were included. To investigate benefits and risks, randomized and quasi-randomized trials comparing oxytocin augmentation with placebo or no oxytocin were included. To explore risks more broadly, cohort and case–control studies were also included. Data were extracted and quality-assessed by 2 researchers using a modified Newcastle–Ottawa scale. Generic inverse variance outcome and a random-effects model were used. Adjusted or crude effect measures with 95% confidence intervals were used. In total, 42 studies were included, presenting data from 885 health facilities in 25 low- and lower-middle-income countries (124,643 women). Rates of oxytocin for labor augmentation varied from 0.7% to 97.0%, exceeding 30% in 14 countries. Four studies investigated timing of oxytocin for augmentation and found that 89.5% (2745) of labors augmented with oxytocin did not cross the partograph's action line. Four cohort and 7 case–control studies assessed perinatal outcomes. Meta-analysis revealed that oxytocin was associated with: stillbirth and day-1 neonatal mortality (relative risk, 1.45; 95% confidence interval, 1.02–2.06; N=84,077; 6 studies); low Apgar score (relative risk, 1.54; 95% confidence interval, 1.21–1.96; N=80,157; 4 studies); neonatal resuscitation (relative risk, 2.69; 95% confidence interval, 1.87–3.88; N=86,750; 3 studies); and neonatal encephalopathy (relative risk, 2.90; 95% confidence interval, 1.87–4.49; N=1383; 2 studies). No studies assessed effects on cesarean birth rate and uterine rupture. This review discloses a concerning level of oxytocin use, including in labors that often did not fulfill criteria for dystocia. Although this finding is limited by confounding by indication, oxytocin seems associated with increased perinatal risks, which are likely mediated by inadequate fetal monitoring. We call for cautious use on clear indications and robust implementation research to support evidence-based guidelines for labor augmentation, particularly in low-resource settings.

While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants’ perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers’ clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained. Trial registration number: NCT04685668

Effective, low-cost clinical interventions to improve facility-based care during childbirth are critical to reduce maternal and perinatal mortality and morbidity in low-resource settings. While health interventions for low- and lower-middle-income countries are often developed and implemented top-down, needs and circumstances vary greatly across locations. Our pilot study in Zanzibar improved care through locally co-created intrapartum clinical practice guidelines (CPGs) and associated training (the PartoMa intervention). This intervention was context-tailored with health-care providers in Zanzibar and now scaled up within five maternity units in Dar es Salaam, Tanzania. This PartoMa Scale-up Study thereby provides an opportunity to explore the co-creation process and modification of the intervention in another context and how scale-up might be successfully achieved. The overall protocol is presented in a separate paper. The aim of the present paper is to account for the Scale-up Study’s programme theory and qualitative methodology. We introduce social practice theory and argue for its value within the programme theory and towards qualitative explorations of shifts in clinical practice. The theory recognizes that the practice we aim to strengthen – safe and respectful clinical childbirth care – is not practiced in a vacuum but embedded within a socio-material context and intertwined with other practices. Methodologically, the project draws on ethnographic and participatory methodologies to explore current childbirth care practices. In line with our programme theory, explorations will focus on meanings of childbirth care, material tools and competencies that are being drawn upon, birth attendants’ motivations and relational contexts, as well as other everyday practices of childbirth care. Insights generated from this study will not only elucidate active ingredients that make the PartoMa intervention feasible (or not) but develop the knowledge foundation for scaling-up and replicability of future interventions based on the principles of co-creation and contextualisation.