Incidence and determinants of perinatal mortality in five urban hospitals in Dar es Salaam, Tanzania: a cohort study with an embedded case-control analysis.

INTRODUCTION: Tanzania has one of the highest burdens of perinatal mortality, with a higher risk among urban versus rural women. To understand the characteristics of perinatal mortality in urban health facilities, study objectives were: I. To assess the incidence of perinatal deaths in public health facilities in Dar es Salaam and classify these into a) pre-facility stillbirths (absence of fetal heart tones on admission to the study health facilities) and b) intra-facility perinatal deaths before discharge; and II. To identify determinants of perinatal deaths by comparing each of the two groups of perinatal deaths with healthy newborns. METHODS: This was a retrospective cohort study among women who gave birth in five urban, public health facilities in Dar es Salaam. I. Incidence of perinatal death in the year 2020 was calculated based on routinely collected health facility records and the Perinatal Problem Identification Database. II. An embedded case-control study was conducted within a sub-population of singletons with birthweight ≥ 2000 g (excluding newborns with congenital malformations); pre-facility stillbirths and intra-facility perinatal deaths were compared with 'healthy newborns' (Apgar score ≥ 8 at one and ≥ 9 at five minutes and discharged home alive). Descriptive and logistic regression analyses were performed to explore the determinants of deaths. RESULTS: A total of 37,787 births were recorded in 2020. The pre-discharge perinatal death rate was 38.3 per 1,000 total births: a stillbirth rate of 27.7 per 1,000 total births and an intra-facility neonatal death rate of 10.9 per 1,000 live births. Pre-facility stillbirths accounted for 88.4% of the stillbirths. The case-control study included 2,224 women (452 pre-facility stillbirths; 287 intra-facility perinatal deaths and 1,485 controls), 99% of whom attended antenatal clinic (75% with more than three visits). Pre-facility stillbirths were associated with low birth weight (cOR 4.40; (95% CI: 3.13-6.18) and with maternal hypertension (cOR 4.72; 95% CI: 3.30-6.76). Intra-facility perinatal deaths were associated with breech presentation (aOR 40.3; 95% CI: 8.75-185.61), complications in the second stage (aOR 20.04; 95% CI: 12.02-33.41), low birth weight (aOR 5.57; 95% CI: 2.62-11.84), cervical dilation crossing the partograph's action line (aOR 4.16; 95% CI:2.29-7.56), and hypertension during intrapartum care (aOR 2.9; 95% CI 1.03-8.14), among other factors.  CONCLUSION: The perinatal death rate in the five urban hospitals was linked to gaps in the quality of antenatal and intrapartum care, in the study health facilities and in lower-level referral clinics. Urgent action is required to implement context-specific interventions and conduct implementation research to strengthen the urban referral system across the entire continuum of care from pregnancy onset to postpartum. The role of hypertensive disorders in pregnancy as a crucial determinant of perinatal deaths emphasizes the complexities of maternal-perinatal health within urban settings.

The Dilemmas and Opportunities of Co-Creating Health Interventions to Fit Local Contexts: An Ethnographic Study on the Adaptation of Clinical Guidelines in Tanzania.

INTRODUCTION: Healthcare providers' role in co-creating health interventions and implementation strategies has evolved significantly, and yet, there is little documentation of this from low-resource settings. This study aims to share the dilemmas of engaging healthcare providers in co-creating locally adapted clinical guidelines for maternity facilities in Dar es Salaam, Tanzania, and strategies used to address them. METHODS: An ethnographic study explored the co-creation of locally adapted clinical guidelines for childbirth care within five maternity facilities in Dar es Salaam. Participant observations were conducted during 11 co-creation workshops. Six in-depth interviews explored participant experiences. Data were analyzed using Attride-Stirling's thematic network analysis framework. RESULTS: The analysis revealed four themes representing dilemmas in the co-creation process and strategies to improve co-creation: (i) navigating diverse contexts: adapting a single set of guidelines to various, diverse facilities was challenging; this was addressed through engaging in dialogue and flexibility while adjusting care practices. (ii) Competing knowledge systems and sources: differing knowledge sources between researchers and healthcare providers challenged discussions on recommended practices. However, validating scientific recommendations with practical care experience in this context helped bridge this gap. (iii) Fostering meaningful participation: participation was time-consuming for some. However, early stakeholder engagement and facility-led participant selection facilitated the meaningful involvement of healthcare providers. (iv) Power imbalances: power dynamics influenced the co-creation process; involving stakeholders in planning and co-facilitating workshops helped mitigate these imbalances and encourage more equal participation. CONCLUSION: Navigating contextual variation, differences in knowledge systems, meaningful participation and power dynamics were key challenges in the co-creation process. However, reflexivity, open and honest dialogue with stakeholders and early engagement enhanced the co-creation process. Co-creating locally adapted clinical guidelines with frontline healthcare workers and scientific experts is essential for feasibility and safety. Further research is needed to explore context specificity, decision-making and the efficacy of co-creation in low-resource settings. PATIENT OR PUBLIC CONTRIBUTION: Healthcare providers and health managers from five maternity facilities who participated in the co-creation process were actively involved in this study by providing their consent to be interviewed about their experiences of participation. CLINICAL TRIAL REGISTRATION: This study is a substudy within the PartoMa project. PartoMa is a registered clinical trial with the trial registration number NCT04685668. PartoMa's date of initial trial registration is 28 December 2020.

Quality of intrapartum care: direct observations in a low-resource tertiary hospital.

BACKGROUND: The majority of the world's perinatal deaths occur in low- and middle-income countries. A substantial proportion occurs intrapartum and is avoidable with better care. At a low-resource tertiary hospital, this study assessed the quality of intrapartum care and adherence to locally-tailored clinical guidelines. METHODS: A non-participatory, structured, direct observation study was held at Mnazi Mmoja Hospital, Zanzibar, Tanzania, between October and November 2016. Women in active labour were followed and structure, processes of labour care and outcomes of care systematically recorded. Descriptive analyses were performed on the labour observations and compared to local guidelines and supplemented by qualitative findings. A Poisson regression analysis assessed factors affecting foetal heart rate monitoring (FHRM) guidelines adherence. RESULTS: 161 labouring women were observed. The nurse/midwife-to-labouring-women ratio of 1:4, resulted in doctors providing a significant part of intrapartum monitoring. Care during labour and two-thirds of deliveries was provided in a one-room labour ward with shared beds. Screening for privacy and communication of examination findings were done in 50 and 34%, respectively. For the majority, there was delayed recognition of labour progress and insufficient support in second stage of labour. While FHRM was generally performed suboptimally with a median interval of 105 (interquartile range 57-160) minutes, occurrence of an intrapartum risk event (non-reassuring FHR, oxytocin use or poor progress) increased assessment frequency significantly (rate ratio 1.32 (CI 1.09-1.58)). CONCLUSIONS: Neither international nor locally-adapted standards of intrapartum routine care were optimally achieved. This was most likely due to a grossly inadequate capacity of birth attendants; without whom innovative interventions at birth are unlikely to succeed. This calls for international and local stakeholders to address the root causes of unsafe intrafacility care in low-resource settings, including the number of skilled birth attendants required for safe and respectful births.

Local adaption of intrapartum clinical guidelines, United Republic of Tanzania.

PROBLEM: Gaps exist between internationally derived clinical guidelines on care at the time of birth and realistic best practices in busy, low-resourced maternity units. APPROACH: In 2014-2018, we carried out the PartoMa study at Zanzibar's tertiary hospital, United Republic of Tanzania. Working with local birth attendants and external experts, we created easy-to-use and locally achievable clinical guidelines and associated in-house training to assist birth attendants in intrapartum care. LOCAL SETTING: Around 11 500 women gave birth annually in the hospital. Of the 35-40 birth attendants employed, each cared simultaneously for 3-6 women in labour. At baseline (1 October 2014 to 31 January 2015), there were 59 stillbirths per 1000 total births and 52 newborns with an Apgar score of 1-5 per 1000 live births. Externally derived clinical guidelines were available, but rarely used. RELEVANT CHANGES: Staff attendance at the repeated trainings was good, despite seminars being outside working hours and without additional remuneration. Many birth attendants appreciated the intervention and were motivated to improve care. Improvements were found in knowledge, partograph skills and quality of care. After 12 intervention months, stillbirths had decreased 34% to 39 per 1000 total births, while newborns with an Apgar score of 1-5 halved to 28 per 1000 live births. LESSONS LEARNT: After 4 years, birth attendants still express high demand for the intervention. The development of international, regional and national clinical guidelines targeted at low-resource maternity units needs to be better attuned to input from end-users and the local conditions, and thereby easier to use effectively.

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).

Length-of-stay and factors associated with early discharge after birth in health facilities in Guinea by mode of birth: Secondary analysis of Demographic and Health Survey 2018.

The immediate postpartum period (first 24 hours after birth) represents a critical time for women and newborns. Postnatal length-of-stay varies globally; in Guinea, a 24-hour facility stay following childbirth is recommended, with an emphasis on providing frequent monitoring of mother and newborn for the first 6 hours. This study describes postpartum length-of-stay following facility-based births in Guinea, and investigates factors associated with early discharge. This cross-sectional study analysed secondary Demographic and Health Survey data covering the most recent livebirths during 2013-2018. We included 2,763 women who gave birth vaginally or by caesarean section in healthcare facilities. Early discharge following vaginal birth was defined according to two cut-offs (<24 hours and <6 hours); early discharge following caesarean section was defined as <72 hours. We assessed socio-demographic, obstetric and health-system factors associated with early discharge using binary and multi-variable logistic regression. Among women with a vaginal birth, 81.5% were discharged <6 hours, with a median length-of-stay of 3 hours. 28% of women who had caesarean section were discharged <72 hours. Odds of discharge <6 hours among women who gave birth vaginally were lower for births in non-government hospital(aOR = 0.55[95%CI = 0.35;0.85]), and multiple births(aOR = 0.54[95%CI = 0.31;0.94]); while the odds were higher in five of the 8 regions compared to Boké. Among women who gave birth by caesarean section, odds of discharge <72 hours were lower for births in government hospitals(aOR = 0.09[95%CI = 0.03;0.3]), and girl newborns(aOR = 0.15[95%CI = 0.05;0.48]).This study showed that postpartum length-of-stays in Guinea is on average shorter than the local recommendations, with the majority of postpartum women with vaginal births spending less than 6-hours in health facilities after birth. Early discharge was associated with type of facility of birth and region. This warrants an in-depth exploration of reasons related to women's and families' preferences, health workers' practices, resource availability, and whether/how early discharge affects postpartum quality-of-care and health outcomes.

'I am happy to be listened to': co-creation of a simple tool to measure women's experiences of respectful maternity care in urban Tanzania.

BACKGROUND: Rights-based Respectful Maternity Care (RMC) is crucial for quality of care and improved birth outcomes, yet RMC measurements are rarely included in facility improvement initiatives. We aimed to (i) co-create a routine RMC measurement tool (RMC-T) for congested maternity units in Dar es Salaam, Tanzania, and (ii) assess the RMC-T's acceptability among women and healthcare stakeholders. METHOD: We employed a participatory approach utilizing multiple mixed methods. This included a scoping review, stakeholder engagement involving postnatal women, healthcare providers, health leadership, and global researchers through interviews, focus groups, and two surveys involving 201 and 838 postnatal women. Cronbach's alpha and factor analysis were conducted for validation using Stata 15. Theories of social practice and Thematic Framework of Acceptability guided the assessment of stakeholder priorities and tool acceptability. RESULTS: The multi-phased iterative co-creation process produced the 25-question RMC-T that measures satisfaction, communication, mistreatment (including physical, verbal, and sexual abuse; neglect; discrimination; lack of privacy; unconsented care; post-birth clean-up; informal payments; and denial of care), supportive care (such as food intake and mobility), birth companionship, post-procedure pain relief, bed-sharing, and newborn respect. The pragmatic validation process prioritized stakeholder feedback over strict statistics, lowering Cronbach's alpha from 0.70 in version 1 to 0.57 for the RMC-T. Women valued the opportunity to share their experiences. CONCLUSIONS: The RMC-T is contextualized, validated, and acceptable for measuring women's experiences of RMC. Routine use in facility-based quality improvement initiatives, along with targeted actions to address gaps, will advance rights-based RMC. Further validation and community-based studies are needed.

• Main findings: This study describes the participatory approach involving postnatal women, healthcare providers, health leadership, and global researchers to co-create and validate a tool for measuring women's experiences of respectful maternity care in Dar es Salaam's urban health facilities.• Added knowledge: The iterative process produced a concise, 25-item Respectful Maternity Care Measurement tool that is user-friendly, administered in 15­20 minutes and addresses all mistreatment domains. The tool reflects women's priorities and is well accepted by postnatal women and health leaders.• Global health impact for policy and action: Regular use of the tool can enhance awareness of childbirth rights and drive actions to improve and normalize respectful maternity care in low-resource urban settings.

Maternal perception of fetal movements: Views, knowledge and practices of women and health providers in a low-resource setting.

The study assessed perception, knowledge, and practices regarding maternal perception of fetal movements (FMs) among women and their healthcare providers in a low-resource setting. Semi-structured interviews, questionnaires and focus group discussions were conducted with 45 Zanzibar women (18 antenatal, 28 postpartum) and 28 health providers at the maternity unit of Mnazi Mmoja Hospital, Zanzibar, Tanzania. Descriptive and thematic analyses were conducted to systematically extract subthemes within four main themes 1) knowledge/awareness, 2) behavior/practice, 3) barriers, and 4) ways to improve practice. Within the main themes it was found that 1) Women were instinctively aware of (ab)normal FM-patterns and healthcare providers had adequate knowledge about FMs. 2) Women often did not know how to monitor FMs or when to report concerns. There was inadequate assessment and management of (ab)normal FMs. 3) Barriers included the fact that women did not feel free to express concerns. Healthcare providers considered FM-awareness among women as low and unreliable. There was lack of staff, time and space for FM-education, and no protocol for FM-management. 4) Women and health providers recognised the need for education on assessment and management of (ab)normal FMs. In conclusion, women demonstrated adequate understanding of FMs and perceived abnormalities of these movements better than assumed by health providers. There is a need for more evidence on the effect of improving knowledge and awareness of FMs to construct evidence-based guidelines for low resource settings.

Prevention and Screening for Cardiometabolic Disease Following Hypertensive Disorders in Pregnancy in Low-Resource Settings: A Systematic Review and Delphi Study.

Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for cardiometabolic and kidney diseases, cost-effective, scalable strategies for screening and prevention in women with a history of HDP are lacking. Existing guidelines and recommendations require adaptation to LMIC settings. This article aims to generate consensus-based recommendations for the prevention and screening of cardiometabolic and kidney diseases tailored for implementation in LMICs. We conducted a systematic review of guidelines and recommendations for prevention and screening strategies for cardiometabolic and chronic kidney diseases following HDP. We searched PubMed/Medline, Embase and Cochrane Library for relevant articles and guidelines published from 2010 to 2021 from both high-income countries (HICs) and LMICs. No other filters were applied. References of included articles were also assessed for eligibility. Findings were synthesized narratively. The summary of guiding recommendations was subjected to two rounds of Delphi consensus surveys with experts experienced in LMIC settings. Fifty-four articles and 9 guidelines were identified, of which 25 were included. Thirty-five clinical recommendations were synthesized from these and classified into six domains: identification of women with HDP (4 recommendations), timing of first counseling and provision of health education (2 recommendations), structure and care setting (12 recommendations), information and communication needs (5 recommendations), cardiometabolic biomarkers (8 recommendations) and biomarkers thresholds (4 recommendations). The Delphi panel reached consensus on 33 final recommendations. These recommendations for health workers in LMICs provide practical and scalable approaches for effective screening and prevention of cardiometabolic disease following HDP. Monitoring and evaluation of implementation of these recommendations provide opportunities for reducing the escalating burden of noncommunicable diseases in LMICs.

Development of a clinical prediction model for perinatal deaths in low resource settings.

BACKGROUND: Most pregnancy-related deaths in low and middle income countries occur around the time of birth and are avoidable with timely care. This study aimed to develop a prognostic model to identify women at risk of intrapartum-related perinatal deaths in low-resourced settings, by (1) external validation of an existing prediction model, and subsequently (2) development of a novel model. METHODS: A prospective cohort study was conducted among pregnant women who presented consecutively for delivery at the maternity unit of Zanzibar's tertiary hospital, Mnazi Mmoja Hospital, the Republic of Tanzania between October 2017 and May 2018. Candidate predictors of perinatal deaths included maternal and foetal characteristics obtained from routine history and physical examination at the time of admission to the labour ward. The outcomes were intrapartum stillbirths and neonatal death before hospital discharge. An existing stillbirth prediction model with six predictors from Nigeria was applied to the Zanzibar cohort to assess its discrimination and calibration performance. Subsequently, a new prediction model was developed using multivariable logistic regression. Model performance was evaluated through internal validation and corrected for overfitting using bootstrapping methods. FINDINGS: 5747 mother-baby pairs were analysed. The existing model showed poor discrimination performance (c-statistic 0·57). The new model included 15 clinical predictors and showed promising discriminative and calibration performance after internal validation (optimism adjusted c-statistic of 0·78, optimism adjusted calibration slope =0·94). INTERPRETATION: The new model consisted of predictors easily obtained through history-taking and physical examination at the time of admission to the labour ward. It had good performance in predicting risk of perinatal death in women admitted in labour wards. Therefore, it has the potential to assist skilled birth attendance to triage women for appropriate management during labour. Before routine implementation, external validation and usefulness should be determined in future studies. FUNDING: The study received funding from Laerdal Foundation, Otto Kranendonk Fund and UMC Global Health Fellowship. TD acknowledges financial support from the Netherlands Organisation for Health Research and Development (grant 91617050).

Labor augmentation with oxytocin in low- and lower-middle-income countries: a systematic review and meta-analysis.

OBJECTIVE: 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. DATA SOURCES: PubMed, Embase, PsycINFO, Index Medicus, Cochrane, and Google Scholar were searched for publications until January 1, 2022. STUDY ELIGIBILITY CRITERIA: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

The application of WHO ICD-PM: Feasibility for the classification of timing and causes of perinatal deaths in a busy birth centre in a low-income country.

OBJECTIVE: To assess the feasibility of the application of International Classification of Diseases-10-to perinatal mortality (ICD-PM) in a busy low-income referral hospital and determine the timing and causes of perinatal deaths, and associated maternal conditions. DESIGN: Prospective application of ICD-PM. SETTING: Referral hospital of Mnazi Mmoja Hospital, Zanzibar, United Republic of Tanzania. POPULATION: Stillbirths and neonatal deaths with a birth weight above 1000 grams born between October 16th 2017 to May 31st 2018. METHODS: Clinical information and an adapted WHO ICD-PM interactive excel-based system were used to capture and classify the deaths according to timing, causes and associated maternal complications. Descriptive analysis was performed. MAIN OUTCOME MEASURES: Timing and causes of perinatal mortality and their associated maternal conditions. RESULTS: There were 661 perinatal deaths of which 248 (37.5%) were neonatal deaths and 413 (62.5%) stillbirths. Of the stillbirths, 128 (31%) occurred antepartum, 129 (31%) intrapartum and for 156 (38%) the timing was unknown. Half (n = 64/128) of the antepartum stillbirths were unexplained. Two-thirds (67%, n = 87/129) of intrapartum stillbirths followed acute intrapartum events, and 30% (39/129) were unexplained. Of the neonatal deaths, 40% died after complications of intrapartum events. CONCLUSION: Problems of documentation, lack of perinatal death audits, capacity for investigations, and guidelines for the unambiguous objective assignment of timing and primary causes of death are major threats for accurate determination of timing and specific primary causes of perinatal deaths.

The injustice of unfit clinical practice guidelines in low-resource realities.

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.