Scaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study).

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.

Scaling up Locally Adapted Clinical Practice Guidelines for Improving Childbirth Care in Tanzania: A Protocol for Programme Theory and Qualitative Methods of the PartoMa Scale-up Study.

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.

Validity of WHO's near-miss approach in a high maternal mortality setting.

OBJECTIVE: To evaluate the validity of WHO's near-miss approach in a low-resource, high maternal mortality setting. DESIGN: Prospective cohort study. SETTING: Mnazi Mmoja Hospital, the main referral hospital of Zanzibar, Tanzania, from 1 April 2017 until 31 December 2018. POPULATION: All women, pregnant or until 42 days after the end of pregnancy, admitted at Mnazi Mmoja Hospital, the tertiary referral hospital in Zanzibar. METHODS: Cases of maternal morbidity and mortality were evaluated according to WHO's near-miss approach. The approach's performance was determined by calculating its accuracy through sensitivity, specificity and positive and negative likelihood ratios. The approach's validity was assessed with Pearson's correlation coefficient between the number of organ dysfunction markers and risk of mortality. MAIN OUTCOMES MEASURES: Correlation between number of organ dysfunction markers and risk of mortality, sensitivity and specificity. RESULTS: 26,842 women were included. There were 335 with a severe maternal outcome: 256 maternal near-miss cases and 79 maternal deaths. No signs of organ dysfunction were documented in only 4 of the 79 cases of maternal death. The number of organ dysfunction markers was highly correlated to the risk of mortality with Pearson's correlation coefficient of 0.89. CONCLUSIONS: WHO's near-miss approach adequately identifies women at high risk of maternal mortality in Zanzibar's referral hospital. There is a strong correlation between the number of markers of organ dysfunction and mortality risk.

Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions.

BACKGROUND: While international guidelines for intrapartum care appear to have increased rapidly since 2000, literature suggests that it has only in few instances been matched with reviews of local modifications, use, and impact at the targeted low resource facilities. At a Tanzanian referral hospital, this paper describes the development process of locally achievable, partograph-associated, and peer-reviewed labour management guidelines, and it presents an assessment of professional birth attendants' perceptions. METHODS: Part 1: Modification of evidence-based international guidelines through repeated evaluation cycles by local staff and seven external specialists in midwifery/obstetrics. Part 2: Questionnaire evaluation 12 months post-implementation of perceptions and use among professional birth attendants. RESULTS: Part 1: After the development process, including three rounds of evaluation by staff and two external peer-review cycles, there were no major concerns with the guidelines internally nor externally. Thereby, international recommendations were condensed to the eight-paged 'PartoMa guidelines ©'. This pocket booklet includes routine assessments, supportive care, and management of common abnormalities in foetal heart rate, labour progress, and maternal condition. It uses colour codes indicating urgency. Compared to international guidelines, reductions were made in frequency of assessments, information load, and ambiguity. Part 2: Response rate of 84% (n = 84). The majority of staff (93%) agreed that the guidelines helped to improve care. They found the guidelines achievable (89%), and the graphics worked well (90%). Doctors more often than nurse-midwives (89% versus 74%) responded to use the guidelines daily. CONCLUSIONS: The PartoMa guidelines ensure readily available, locally achievable, and acceptable support for intrapartum surveillance, triage, and management. This is a crucial example of adapting evidence-based international recommendations to local reality. TRIAL REGISTRATION: This paper describes the intervention of the PartoMa trial, which is registered on ClinicalTrials.org ( NCT02318420 , 4th November 2014).

Stillbirths and quality of care during labour at the low resource referral hospital of Zanzibar: a case-control study.

BACKGROUND: To study determinants of stillbirths as indicators of quality of care during labour in an East African low resource referral hospital. METHODS: A criterion-based unmatched unblinded case-control study of singleton stillbirths with birthweight ≥2000 g (n = 139), compared to controls with birthweight ≥2000 g and Apgar score ≥7 (n = 249). RESULTS: The overall facility-based stillbirth rate was 59 per 1000 total births, of which 25 % was not reported in the hospital's registers. The majority of singletons had birthweight ≥2000 g (n = 139; 79 %), and foetal heart rate was present on admission in 72 (52 %) of these (intra-hospital stillbirths). Overall, poor quality of care during labour was the prevailing determinant of 71 (99 %) intra-hospital stillbirths, and median time from last foetal heart assessment till diagnosis of foetal death or delivery was 210 min. (interquartile range: 75-315 min.). Of intra-hospital stillbirths, 26 (36 %) received oxytocin augmentation (23 % among controls; odds ratio (OR) 1.86, 95 % confidential interval (CI) 1.06-3.27); 15 (58 %) on doubtful indication where either labour progress was normal or less dangerous interventions could have been effective, e.g. rupture of membranes. Substandard management of prolonged labour frequently led to unnecessary caesarean sections. The caesarean section rate among all stillbirths was 26 % (11 % among controls; OR 2.94, 95 % CI 1.68-5.14), and vacuum extraction was hardly ever done. Of women experiencing stillbirth, 27 (19 %) had severe hypertensive disorders (4 % among controls; OR 5.76, 95 % CI 2.70-12.31), but 18 (67 %) of these did not receive antihypertensives. An additional 33 (24 %) did not have blood pressure recorded during active labour. When compared to controls, stillbirths were characterized by longer admissions during labour. However, substandard care was prevalent in both cases and controls and caused potential risks for the entire population. Notably, women with foetal death on admission were in the biggest danger of neglect. CONCLUSIONS: Intrapartum management of women experiencing stillbirth was a simple yet strong indicator of quality of care. Substandard care led to perinatal as well as maternal risks, which furthermore were related to unnecessary complex, time consuming, and costly interventions. Improvement of obstetric care is warranted to end preventable birth-related deaths and disabilities. TRIAL REGISTRATION: This is the baseline analysis of the PartoMa trial, which is registered on ClinicalTrials.org ( NCT02318420 , 4th November 2014).