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BackgroundPostpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a 'clinical care bundle' for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the "E-MOTIVE" bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice.MethodsWe will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops.DiscussionThis formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective.Trial registrationClinicalTrials.gov: NCT04341662.

Abstract Background The lack of reliable and up-to-date statistics on maternal deaths and disabilities remains a major challenge to the implementation of Nigeria's Road Map to Accelerate the Millennium Development Goal related to Maternal Health (MDG-5). There are currently no functioning national data sources on maternal deaths and disabilities that could serve as reference points for programme managers, health advocates and policy makers. While awaiting the success of efforts targeted at overcoming the barriers facing establishment of population-based data systems, referral institutions in Nigeria can contribute their quota in the quest towards MDG-5 by providing good quality and reliable information on maternal deaths and disabilities on a continuous basis. This project represents the first opportunity to initiate a scientifically sound and reliable quantitative system of data gathering on maternal health profile in Nigeria. Objective The primary objective is to create a national data system on maternal near miss (MNM) and maternal mortality in Nigerian public tertiary institutions. This system will conduct periodically, both regionally and at country level, a review of the magnitude of MNM and maternal deaths, nature of events responsible for MNM and maternal deaths, indices for the quality of care for direct obstetric complications and the health service events surrounding these complications, in an attempt to collectively define and monitor the standard of comprehensive emergency obstetric care in the country. Methods This will be a nationwide cohort study of all women who experience MNM and those who die from pregnancy, childbirth and puerperal complications using uniform criteria among women admitted in tertiary healthcare facilities in the six geopolitical zones in Nigeria. This will be accomplished by establishing a network of all public tertiary obstetric referral institutions that will prospectively collect specific information on potentially fatal maternal complications. For every woman enrolled, the health service events (care pathways) within the facility will be evaluated to identify areas of substandard care/avoidable factors through clinical audit by the local research team. A summary estimate of the frequencies of MNM and maternal deaths will be determined at intervals and indicators of quality of care (case fatality rate, both total and cause-specific and mortality index) will be evaluated at facility, regional and country levels. Management Overall project management will be from the Centre for Research in Reproductive Health (CRRH), Sagamu, Nigeria. There will be at least two meetings and site visits for efficient coordination of the project by regional coordinators and central coordinating staff. Data will be transferred electronically by hospital and regional coordinators and managed at the Data Management Unit of CRRH, Sagamu, Nigeria. Expected outcomes The outcome of the study would provide useful information to the health practitioners, policy-makers and international partners on the strengths and weaknesses of the infrastructures provided for comprehensive emergency obstetric care in Nigeria. The successful implementation of this project will pave way for the long-awaited Confidential Enquiries into Maternal Deaths that would guide the formulation and or revision of obstetric policies and practices in Nigeria. Lessons learnt from the establishment of this data system can also be used to set up similar structures at lower levels of healthcare delivery in Nigeria.

Abstract Aim To determine the frequency of near-miss (severe acute maternal morbidity) and the nature of near-miss events, and comparatively analysed near-miss morbidities and maternal deaths among pregnant women managed over a 3-year period in a Nigerian tertiary centre. Methods Retrospective facility-based review of cases of near-miss and maternal death which occurred between 1 January 2002 and 31 December 2004. Near-miss case definition was based on validated disease-specific criteria, comprising of five diagnostic categories: haemorrhage, hypertensive disorders in pregnancy, dystocia, infection and anaemia. The near-miss morbidities were compared with maternal deaths with respect to demographic features and disease profiles. Mortality indices were determined for various disease processes to appreciate the standard of care provided for life-threatening obstetric conditions. The maternal death to near-miss ratios for the three years were compared to assess the trend in the quality of obstetric care. Results There were 1501 deliveries, 211 near-miss cases and 44 maternal deaths. The total near-miss events were 242 with a decreasing trend from 2002 to 2004. Demographic features of cases of near-miss and maternal death were comparable. Besides infectious morbidity, the categories of complications responsible for near-misses and maternal deaths followed the same order of decreasing frequency. Hypertensive disorders in pregnancy and haemorrhage were responsible for 61.1% of near-miss cases and 50.0% of maternal deaths. More women died after developing severe morbidity due to uterine rupture and infection, with mortality indices of 37.5% and 28.6%, respectively. Early pregnancy complications and antepartum haemorrhage had the lowest mortality indices. Majority of the cases of near-miss (82.5%) and maternal death (88.6%) were unbooked for antenatal care and delivery in this hospital. Maternal mortality ratio for the period was 2931.4 per 100,000 deliveries. The overall maternal death to near-miss ratio was 1: 4.8 and this remained relatively constant over the 3-year period. Conclusion The quality of care received by critically ill obstetric patients in this centre is suboptimal with no evident changes between 2002 and 2004. Reduction of the present maternal mortality ratio may best be achieved by developing evidence-based protocols and improving the resources for managing severe morbidities due to hypertension and haemorrhage especially in critically ill unbooked patients. Tertiary care hospitals in Nigeria could also benefit from evaluation of their standard of obstetric care by including near-miss investigations in their maternal death enquiries.

Background: The dearth of health personnel in low income countries has attracted global attention. Ways as to how health care services can be delivered in a more efficient and effective way using available health personnel are being explored. Task-sharing expands the responsibilities of low-cadre health workers and allows them to share these responsibilities with highly qualified health care providers in an effort to best utilize available human resources. This is appropriate in a country like Nigeria where there is a shortage of qualified health professionals and a huge burden of maternal mortality resulting from obstetric complications like pre-eclampsia. This study examines the prospect for task-sharing among Community Health Extension Workers (CHEW) for the detection of early signs of pre-eclampsia, in Ogun State, Nigeria. Methods: This study is part of a larger community-based trial evaluating the acceptability of community treatment for severe pre-eclampsia in Ogun State, Nigeria. Data was collected between 2011 and 2012 using focus group discussions; seven with CHEWs (n = 71), three with male decision-makers (n = 35), six with community leaders (n = 68), and one with member of the Society of Obstetricians and Gynaecologists of Nigeria (n = 9). In addition, interviews were conducted with the heads of the local government administration (n =4), directors of planning (n = 4), medical officers (n = 4), and Chief Nursing Officers (n = 4). Qualitative data were analysed using NVivo version 10.0 3 computer software. Results: The non-availability of health personnel is a major challenge, and has resulted in a high proportion of facility-based care performed by CHEWs. As a result, CHEWs often take on roles that are designated for senior health workers. This role expansion has exposed CHEWs to the basics of obstetric care, and has resulted in informal task-sharing among the health workers. The knowledge and ability of CHEWs to perform basic clinical assessments, such as measure blood pressure is not in doubt. Nevertheless, there were divergent views by senior and junior cadres of health practitioners about CHEWs' abilities in providing obstetric care. Similarly, there were concerns by various stakeholders, particularly the CHEWs themselves, on the regulatory restrictions placed on them by the Standing Order. Conclusion: Generally, the extent to which obstetric tasks could be shifted to community health workers will be determined by the training provided and the extent to which the observed barriers are addressed. Trial registration: NCT01911494 [ABSTRACT FROM AUTHOR]

Background: In Nigeria, women too often suffer the consequences of serious obstetric complications that may lead to death. Delay in seeking care (phase I delay) is a recognized contributor to adverse pregnancy outcomes. This qualitative study aimed to describe the health care seeking practices in pregnancy, as well as the socio-cultural factors that influence these actions. Methods: The study was conducted in Ogun State, in south-western Nigeria. Data were collected through focus group discussions with pregnant women, recently pregnant mothers, male decision-makers, opinion leaders, traditional birth attendants, health workers, and health administrators. A thematic analysis approach was used with QSR NVivo version 10. Results: Findings show that women utilized multiple care givers during pregnancy, with a preference for traditional providers. There was a strong sense of trust in traditional medicine, particularly that provided by traditional birth attendants who are long-term residents in the community. The patriarchal c influenced health-seeking behaviour in pregnancy. Economic factors contributed to the delay in access to appropriate services. There was a consistent concern regarding the cost barrier in accessing health services. The challenges of accessing services were well recognised and these were greater when referral was to a higher level of care which in most cases attracted unaffordable costs. Conclusion: While the high cost of care is a deterrent to health seeking behaviour, the cost of death of a woman or a child to the family and community is immeasurable. The use of innovative mechanisms for health care financing may be beneficial for women in these communities to reduce the barrier of high cost services. To reduce maternal deaths all stakeholders must be engaged in the process including policy makers, opinion leaders, health care consumers and providers. Underlying socio-cultural factors, such as structure of patriarchy, must also be addressed to sustainably improve maternal health. [ABSTRACT FROM AUTHOR]

Background: Pre-eclampsia is a complication of pregnancy responsible for high rates of morbidity and mortality, particularly in sub-Saharan Africa. When undetected or poorly managed, it may progress to eclampsia which further worsens the prognosis. While most studies examining pre-eclampsia have used a bio-medical model, this study recognizes the role of the socio-cultural environment, in order to understand perceptions of pre-eclampsia within the community. Methods: The study was conducted in Ogun State, Nigeria in 2011-2012. Data were obtained through twenty-eight focus group discussions; seven with pregnant women (N= 80), eight with new mothers (N= 95), three with male decision-makers (N= 35), six with community leaders (N= 68), and three with traditional birth attendants (N= 36). Interviews were also conducted with the heads of the local traditional birth attendants (N = 4) and with community leaders (N = 5). Data were transcribed verbatim and analysed in NVivo 10 software. Results: There was no terminology reportedly used for pre-eclampsia in the native language - Yoruba; however, hypertension has several terms independent of pregnancy status. Generally, 'gìrì âlábôyún' describes seizures specific to pregnancy. The cause of hypertension in pregnancy was thought to be due to depressive thoughts as a result of marital conflict and financial worries, while seizures in pregnancy were perceived to result from prolonged exposure to cold. There seemed to be no traditional treatment for hypertension. However for seizures the use of herbs, concoctions, incisions, and topical application of black soap were widespread. Conclusion: This study illustrates that knowledge of pre-eclampsia and eclampsia are limited amongst communities of Ogun State, Nigeria. Findings reveal that pre-eclampsia was perceived as a stress-induced condition, while eclampsia was perceived as a product of prolonged exposure to cold. Thus, heat-related local medicines and herbal concoctions were the treatment options. Perceptions anchored on cultural values and lack of adequate and focused public health awareness is a major constraint to knowledge of the aetiology and treatment of the conditions. A holistic approach is recommended for sensitization at the community level and the need to change the community perceptions of pre-eclampsia remains a challenge. [ABSTRACT FROM AUTHOR]

Background: Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude. Methods: A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance. Results: Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement. Conclusions: Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts. [ABSTRACT FROM AUTHOR]

Background: Every woman has the right to dignified, respectful care during childbirth. Recent evidence has demonstrated that globally many women experience mistreatment during labour and childbirth in health facilities, which can pose a significant barrier to women attending facilities for delivery and can contribute to poor birth experiences and adverse outcomes for women and newborns. However there is no clear consensus on how mistreatment of women during childbirth in facilities is defined and measured. We propose using a two-phased, mixed-methods study design in four countries to address these research gaps. This protocol describes the Phase 1 qualitative research activities. Methods/Design: We will employ qualitative research methodologies among women, healthcare providers and administrators in the facility catchment areas of two health facilities in each country: Ghana, Guinea, Myanmar and Nigeria. In-depth interviews (IDIs) and focus group discussions (FGDs) will be conducted among women of reproductive age (15-49 years) to explore their perceptions and experiences of facility-based childbirth care, focused on how they were treated by healthcare workers and perceived factors affecting how they were treated. IDIs will also be conducted with healthcare providers of different cadres (e.g.: nurses, midwives, medical officers, specialist obstetricians) and facility administrators working in the selected facilities to explore healthcare providers' perceptions and experiences of facility-based childbirth care and how staff are treated, colleagues and supervisors. Audio recordings will be transcribed and translated to English. Textual data will be analysed using a thematic framework approach and will consist of two levels of analysis: (1) conduct of local analysis workshops with the research assistants in each country; and (2) line-by-line coding to develop a thematic framework and coding scheme. Discussion: This study serves several roles. It will provide an in-depth understanding of how women are treated during childbirth in four countries and perceived factors associated with this mistreatment. It will also provide data on where and how an intervention could be developed to reduce mistreatment and promote respectful care. The findings from this study will contribute to the development of tools to measure the prevalence of mistreatment of women during facility-based childbirth. [ABSTRACT FROM AUTHOR]

Background: The partograph is currently the main tool available to support decision-making of health professionals during labour. However, the rate of appropriate use of the partograph is disappointingly low. Apart from limitations that are associated with partograph use, evidence of positive impact on labour-related health outcomes is lacking. The main goal of this study is to develop a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool. The primary objectives are: to identify the essential elements of intrapartum monitoring that trigger the decision to use interventions aimed at preventing poor labour outcomes; to develop a simplified, monitoring-to-action algorithm for labour management; and to compare the diagnostic performance of SELMA and partograph algorithms as tools to identify women who are likely to develop poor labour-related outcomes. Methods/Design: A prospective cohort study will be conducted in eight health facilities in Nigeria and Uganda (four facilities from each country). All women admitted for vaginal birth will comprise the study population (estimated sample size: 7,812 women). Data will be collected on maternal characteristics on admission, labour events and pregnancy outcomes by trained research assistants at the participating health facilities. Prediction models will be developed to identify women at risk of intrapartum-related perinatal death or morbidity (primary outcomes) throughout the course of labour. These predictions models will be used to assemble a decision-support tool that will be able to suggest the best course of action to avert adverse outcomes during the course of labour. To develop this set of prediction models, we will use up-to-date techniques of prognostic research, including identification of important predictors, assigning of relative weights to each predictor, estimation of the predictive performance of the model through calibration and discrimination, and determination of its potential for application using internal validation techniques. Discussion: This research offers an opportunity to revisit the theoretical basis of the partograph. It is envisioned that the final product would help providers overcome the challenging tasks of promptly interpreting complex labour information and deriving appropriate clinical actions, and thus increase efficiency of the care process, enhance providers' competence and ultimately improve labour outcomes. [ABSTRACT FROM AUTHOR]