Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.

BACKGROUND: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. METHODS: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 µg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. RESULTS: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups. CONCLUSIONS: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

OBJECTIVE: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care. METHODS: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. CONCLUSION: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014-004445-26. Date of registration 14 August 2014 Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding.

Development of caesarean section prediction models: secondary analysis of a prospective cohort study in two sub-Saharan African countries.

BACKGROUND: Caesarean section is recommended in situations in which vaginal birth presents a greater likelihood of adverse maternal or perinatal outcomes than normal. However, it is associated with a higher risk of complications, especially when performed without a clear medical indication. Since labour attendants have no standardised clinical method to assist in this decision, statistical tools developed based on multiple labour variables may be an alternative. The objective of this paper was to develop and evaluate the accuracy of models for caesarean section prediction using maternal and foetal characteristics collected at admission and through labour. METHOD: This is a secondary analysis of the World Health Organization's Better Outcomes in Labour Difficulty prospective cohort study in two sub-Saharan African countries. Data were collected from women admitted for labour and childbirth in 13 hospitals in Nigeria as well as Uganda between 2014 and 2015. We applied logistic regression to develop different models to predict caesarean section, based on the time when intrapartum assessment was made. To evaluate discriminatory capacity of the various models, we calculated: area under the curve, diagnostic accuracy, positive predictive value, negative predictive value, sensitivity and specificity. RESULTS: A total of 8957 pregnant women with 12.67% of caesarean births were used for model development. The model based on labour admission characteristics showed an area under the curve of 78.70%, sensitivity of 63.20%, specificity of 78.68% and accuracy of 76.62%. On the other hand, the models that applied intrapartum assessments performed better, with an area under the curve of 93.66%, sensitivity of 80.12%, specificity of 89.26% and accuracy of 88.03%. CONCLUSION: It is possible to predict the likelihood of intrapartum caesarean section with high accuracy based on labour characteristics and events. However, the accuracy of this prediction is considerably higher when based on information obtained throughout the course of labour.

Progression of the first stage of spontaneous labour: A prospective cohort study in two sub-Saharan African countries.

BACKGROUND: Escalation in the global rates of labour interventions, particularly cesarean section and oxytocin augmentation, has renewed interest in a better understanding of natural labour progression. Methodological advancements in statistical and computational techniques addressing the limitations of pioneer studies have led to novel findings and triggered a re-evaluation of current labour practices. As part of the World Health Organization's Better Outcomes in Labour Difficulty (BOLD) project, which aimed to develop a new labour monitoring-to-action tool, we examined the patterns of labour progression as depicted by cervical dilatation over time in a cohort of women in Nigeria and Uganda who gave birth vaginally following a spontaneous labour onset. METHODS AND FINDINGS: This was a prospective, multicentre, cohort study of 5,606 women with singleton, vertex, term gestation who presented at ≤ 6 cm of cervical dilatation following a spontaneous labour onset that resulted in a vaginal birth with no adverse birth outcomes in 13 hospitals across Nigeria and Uganda. We independently applied survival analysis and multistate Markov models to estimate the duration of labour centimetre by centimetre until 10 cm and the cumulative duration of labour from the cervical dilatation at admission through 10 cm. Multistate Markov and nonlinear mixed models were separately used to construct average labour curves. All analyses were conducted according to three parity groups: parity = 0 (n = 2,166), parity = 1 (n = 1,488), and parity = 2+ (n = 1,952). We performed sensitivity analyses to assess the impact of oxytocin augmentation on labour progression by re-examining the progression patterns after excluding women with augmented labours. Labour was augmented with oxytocin in 40% of nulliparous and 28% of multiparous women. The median time to advance by 1 cm exceeded 1 hour until 5 cm was reached in both nulliparous and multiparous women. Based on a 95th percentile threshold, nulliparous women may take up to 7 hours to progress from 4 to 5 cm and over 3 hours to progress from 5 to 6 cm. Median cumulative duration of labour indicates that nulliparous women admitted at 4 cm, 5 cm, and 6 cm reached 10 cm within an expected time frame if the dilatation rate was ≥ 1 cm/hour, but their corresponding 95th percentiles show that labour could last up to 14, 11, and 9 hours, respectively. Substantial differences exist between actual plots of labour progression of individual women and the 'average labour curves' derived from study population-level data. Exclusion of women with augmented labours from the study population resulted in slightly faster labour progression patterns. CONCLUSIONS: Cervical dilatation during labour in the slowest-yet-normal women can progress more slowly than the widely accepted benchmark of 1 cm/hour, irrespective of parity. Interventions to expedite labour to conform to a cervical dilatation threshold of 1 cm/hour may be inappropriate, especially when applied before 5 cm in nulliparous and multiparous women. Averaged labour curves may not truly reflect the variability associated with labour progression, and their use for decision-making in labour management should be de-emphasized.

WHO Better Outcomes in Labour Difficulty (BOLD) project: innovating to improve quality of care around the time of childbirth.

As most pregnancy-related deaths and morbidities are clustered around the time of childbirth, quality of care during this period is critical to the survival of pregnant women and their babies. Despite the wide acceptance of partograph as the central tool to optimize labour outcomes for over 40 years, its use has not successfully improved outcomes in many settings for several reasons. There are also increasing questions about the validity and applicability of its central feature - "the alert line" - to all women regardless of their labour characteristics. Apart from the known deficiencies in labour care, attempts to improve quality of care in low resource settings have also failed to address and integrate women's birth experience into quality improvement processes. It was against this background that the World Health Organization (WHO) embarked on the Better Outcomes in Labour Difficulty (BOLD) project to improve the quality of intrapartum care in low- and middle-income countries. The main goal of the BOLD project is to reduce intrapartum-related stillbirths, maternal and newborn mortalities and morbidities by addressing the critical barriers to the process of good quality intrapartum care and enhancing the connection between health systems and communities. The project seeks to achieve this goal by (1) developing an evidence-based, easy to use, labour monitoring-to-action decision-support tool (currently termed Simplified, Effective, Labour Monitoring-to-Action - SELMA); and (2) by developing innovative service prototypes/tools, co-designed with users of health services (women, their families and communities) and health providers, to promote access to respectful, dignified and emotionally supportive care for pregnant women and their companions at the time of birth ("Passport to Safer Birth"). This two-pronged approach is expected to positively impact on important domains of quality of care relating to both provision and experience of care. In this paper, we briefly describe the rationale for innovative thinking in relation to improving quality of care around the time of childbirth and introduce WHO current plans to improve care through research, design and implementation of innovative tools and services in the post-2015 era.Please see related articles ' http://dx.doi.org/10.1186/s12978-015-0029-4 ' and ' http://dx.doi.org/10.1186/s12978-015-0028-5 '.

Formative research and development of innovative tools for "Better Outcomes in Labour Difficulty" (BOLD): study protocol.

BACKGROUND: Most complications during labour and childbirth could be averted with timely interventions by skilled healthcare providers. Yet, the quality and outcomes of childbirth care remains suboptimal in many health facilities in low-resource settings. To accelerate the reduction of childbirth-related maternal, fetal and newborn mortality and morbidity, the World Health Organization has initiated the "Better Outcomes in Labour Difficulty" (BOLD) project to address weaknesses in labour care processes and better connect health systems and communities. The project seeks to develop a "Simplified, Effective, Labour Monitoring-to-Action" tool (SELMA) to assist healthcare providers to monitor labour and take decisive actions more efficiently; and by developing an innovative set of service prototypes and/or tools termed "Passport to Safer Birth", designed with communities and healthcare providers, to promote access to quality care for women during childbirth. This protocol describes the formative research activities to support the development of these tools. METHODS/DESIGN: We will employ qualitative research and service design methodologies in eight health facilities and their catchment communities in Nigeria and Uganda. In the health facilities, focus group discussions (FGD) and in-depth interviews (IDI) will be conducted among different cadres of healthcare providers and facility administrators. In the communities, FGDs and IDIs will be conducted among women who have delivered in a health facility. We will use service design methods to explore women's journey to access and receive childbirth care in order to innovate and design services around the needs and expectations of women, within the context of the health system. DISCUSSION: This formative research will serve several roles. First, it will provide an in-depth understanding of healthcare providers and health system issues to be accounted for in the final design and implementation of SELMA. Second, it will help to identify key moments ("touch points") where women's experiences of childbirth care are shaped, and where the overall experience of quality care could be improved. The synthesis of findings from the qualitative and service design activities will help identify potential areas for behaviour change related to the provision and experience of childbirth care, and serve as the basis for the development of Passport to Safer Birth. Please see related articles 'http://dx.doi.org/ 10.1186/s12978-015-0027-6 ' and 'http://dx.doi.org/ 10.1186/s12978-015-0029-4 '.

The development of a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool for Better Outcomes in Labour Difficulty (BOLD): study protocol.

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. Please see related articles ' http://dx.doi.org/10.1186/s12978-015-0027-6 ' and ' http://dx.doi.org/10.1186/s12978-015-0028-5 '.

Maternal and perinatal health research priorities beyond 2015: an international survey and prioritization exercise.

BACKGROUND: Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required. METHODS: We adapted the methods of the Child Health and Nutrition Research Initiative (CHNRI) to identify and set global research priorities for maternal and perinatal health for the period 2015 to 2025. Priority research questions were received from various international stakeholders constituting a large reference group, and consolidated into a final list of research questions by a technical working group. Questions on this list were then scored by the reference working group according to five independent and equally weighted criteria. Normalized research priority scores (NRPS) were calculated, and research priority questions were ranked accordingly. RESULTS: A list of 190 priority research questions for improving maternal and perinatal health was scored by 140 stakeholders. Most priority research questions (89%) were concerned with the evaluation of implementation and delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. CONCLUSIONS: Key research priorities in maternal and perinatal health were identified. The resulting ranked list of research questions provides a valuable resource for health research investors, researchers and other stakeholders. We are hopeful that this exercise will inform the post-2015 Development Agenda and assist donors, research-policy decision makers and researchers to invest in research that will ultimately make the most significant difference in the lives of mothers and babies.

A global analysis of the determinants of maternal health and transitions in maternal mortality.

The reduction of maternal mortality and the promotion of maternal health and wellbeing are complex tasks. This Series paper analyses the distal and proximal determinants of maternal health, as well as the exposures, risk factors, and micro-correlates related to maternal mortality. This paper also examines the relationship between these determinants and the gradual shift over time from a pattern of high maternal mortality to a pattern of low maternal mortality (a phenomenon described as the maternal mortality transition). We conducted two systematic reviews of the literature and we analysed publicly available data on indicators related to the Sustainable Development Goals, specifically, estimates prepared by international organisations, including the UN and the World Bank. We considered 23 frameworks depicting maternal health and wellbeing as a multifactorial process, with superdeterminants that broadly affect women's health and wellbeing before, during, and after pregnancy. We explore the role of social determinants of maternal health, individual characteristics, and health-system features in the production of maternal health and wellbeing. This paper argues that the preventable deaths of millions of women each decade are not solely due to biomedical complications of pregnancy, childbirth, and the postnatal period, but are also tangible manifestations of the prevailing determinants of maternal health and persistent inequities in global health and socioeconomic development. This paper underscores the need for broader, multipronged actions to improve maternal health and wellbeing and accelerate sustainable reductions in maternal mortality. For women who have pregnancy, childbirth, or postpartum complications, the health system provides a crucial opportunity to interrupt the chain of events that can potentially end in maternal death. Ultimately, expanding the health sector ecosystem to mitigate maternal health determinants and tailoring the configuration of health systems to counter the detrimental effects of eco-social forces, including though increased access to quality-assured commodities and services, are essential to improve maternal health and wellbeing and reduce maternal mortality.

Prevalence and determinants of self-reported anxiety and stress among women with abortion-related complications admitted to health facilities in Eastern and Southern Africa: A cross-sectional survey.

OBJECTIVE: To estimate the prevalence of women who were admitted to health facilities with abortion-related complications who reported feeling anxious/stressed during their stay, and to identify sociodemographic, facility, and abortion-related characteristics associated with self-reported experience of anxiety/stress. METHODS: We used data from four countries in Eastern and Southern Africa (Kenya, Malawi, Mozambique, and Uganda) collected from 2017-2018 as part of the World Health Organization (WHO) Multi-Country Survey on Abortion-related morbidity (MCS-A). Information was extracted from women's medical records and their participation in audio computer-assisted self-interviews (ACASI). Based on a question in the ACASI, "Did you encounter any anxiety or stress during your hospital stay?", the percentage of women who self-reported feeling anxious/stressed during their facility stay was calculated. Generalized estimating equations were used to identify the determinants of anxiety/stress following a hierarchical approach whereby potential determinants were grouped from most distal to most proximal and analyzed accordingly. RESULTS: There were 1254 women with abortion-related complications included in the analysis, of which 56.5% self-reported that they felt anxious/stressed during their facility stay. We found evidence that lower socioeconomic status, lower levels of education, no previous childbirth, no previous abortion, higher gestational age at abortion, and use of unsafe methods of abortion were independent determinants of self-reporting anxiety/stress. CONCLUSIONS: Action should be taken to reduce experience of anxiety/stress among women attending facilities for postabortion complications, including reducing the number of women experiencing abortion-related complications by improving access to safe abortion. This issue warrants further study using more comprehensive and validated tools to understand the levels and drivers of anxiety/stress self-reported by women attending facilities with abortion-related complications.

Adolescents' satisfaction with care for abortion-related complications in 11 Sub-Saharan African countries: A cross-sectional facility-based study.

OBJECTIVE: To assess satisfaction with care for abortion-related complications experienced among adolescents compared to older women. METHODS: A secondary analysis of the WHO Multi-Country Survey on Abortion-related Morbidity and Mortality-a cross-sectional study conducted in health facilities in 11 Sub-Saharan African countries. Women with abortion-related complications who participated in an audio computer-assisted self-interview were included. Two composite measures of overall satisfaction were created based on five questions: (1) study participants who were either satisfied or very satisfied across all five questions; and (2) study participants who reported being very satisfied only across all five questions. Multivariable general estimating equation analyses were conducted to assess whether there was any evidence that age (adolescents 12-19 years and older women 20+) was associated with each composite measure of satisfaction, controlling for key confounders. RESULTS: The study sample consisted of 2817 women (15% adolescents). Over 75% of participants reported being satisfied or very satisfied for four out of five questions. Overall, 52.9% of study participants reported being satisfied/very satisfied across all five questions and 22.4% reported being consistently very satisfied. Multivariable analyses showed no evidence of an association between age group and being either satisfied or very satisfied (OR 1.07; 95% CI, 0.82-1.41, P = 0.60), but showed strong evidence that adolescents were 50% more likely to be consistently very satisfied with their overall care than older women (OR 1.49; 95% CI, 1.13-1.96, P = 0.005). CONCLUSION: Both adolescents and older women reported high levels of satisfaction with care when looking at different components of care individually, but the results of the composite measure for satisfaction showed that many study participants reported being less than satisfied with at least one element of their care. Further studies to explore the expectations, needs, and values of women's satisfaction with care for abortion-related complications are needed.

Understanding abortion-related complications in health facilities: results from WHO multicountry survey on abortion (MCS-A) across 11 sub-Saharan African countries.

INTRODUCTION: Complications due to unsafe abortions are an important cause of morbidity and mortality in many sub-Saharan African countries. We aimed to characterise abortion-related complication severity, describe their management, and to report women's experience of abortion care in Africa. METHODS: A cross-sectional study was implemented in 210 health facilities across 11 sub-Saharan African countries. Data were collected on women's characteristics, clinical information and women's experience of abortion care (using the audio computer-assisted self-interviewing (ACASI) system). Severity of abortion complications were organised in five hierarchical mutually exclusive categories based on indicators present at assessment. Descriptive bivariate analysis was performed for women's characteristics, management of complications and reported experiences of abortion care by severity. Generalised linear estimation models were used to assess the association between women's characteristics and severity of complications. RESULTS: There were 13 657 women who had an abortion-related complication: 323 (2.4%) women were classified with severe maternal outcomes, 957 (7.0%) had potentially life-threatening complications, 7953 (58.2%) had moderate complications and 4424 (32.4%) women had mild complications. Women who were single, multiparous, presenting ≥13 weeks of gestational age and where expulsion of products of conception occurred prior to arrival to facility were more likely to experience severe complications. For management, the commonly used mechanical methods of uterine evacuation were manual vacuum aspiration (76.9%), followed by dilation and curettage (D&C) (20.1%). Most frequently used uterotonics were oxytocin (50∙9%) and misoprostol (22.7%). Via ACASI, 602 (19.5%) women reported having an induced abortion. Of those, misoprostol was the most commonly reported method (54.3%). CONCLUSION: There is a critical need to increase access to and quality of evidence-based safe abortion, postabortion care and to improve understanding around women's experiences of abortion care.

Expectations and needs of Ugandan women for improved quality of childbirth care in health facilities: A qualitative study.

OBJECTIVE: To describe the experiences, expectations, and needs of urban Ugandan women in relation to good-quality facility childbirth. METHODS: Women who had given birth in the 12 months prior to the study were purposively sampled and interviewed, or included in focus groups. Thematic analysis was used, and the data were interpreted within the context of an existing quality of care framework. RESULTS: Forty-five in-depth interviews and six focus group discussions were conducted. Respect and dignity, timely communication, competent skilled staff, and availability of medical supplies were central to women's accounts of quality care, or a lack of it. The hope for a live baby motivated women to seek facility-based childbirth. They expected to encounter competent, respectful, and caring staff with appropriate skills. In some cases, they could only fulfill these expectations through additional personal financial payments to staff, for clinical supplies, or to guarantee that they would be attended by someone with suitable skills. CONCLUSION: Long-term improvement in quality of maternity care in Uganda requires enhancement of the interaction between women and health staff in facilities, and investment in staff and resources to ensure that safe, respectful care is not dependent on willingness and/or capacity to pay.

Using a service design model to develop the "Passport to Safer Birth" in Nigeria and Uganda.

OBJECTIVE: To demonstrate how a human-centered service design approach can generate practical tools for good-quality childbirth care in low-resource settings. METHODS: As part of the WHO "Better Outcomes in Labour Difficulty" (BOLD) project, a service design approach was used in eight Ugandan and Nigerian health facilities and communities to develop the "Passport to Safer Birth." There are three phases: Research for Design, Concept Design, and Detail Design. These generated design principles, design archetype personas, and Passport prototypes. Data collection methods included desk research, interviews, group discussions, and journey mapping to identify touchpoints where the woman interacts with the health system. RESULTS: A total of 90 interviews, 12 observation hours, and 15 group discussions were undertaken. The resulting design principles were: a shared and deeper understanding of pregnancy and childbirth among family and community; family readiness for decision-making and action; and the woman's sense of being in control and being cared for. Four archetype personas of women emerged: Vulnerable; Passive; Empowered; Accepter. Subsequent development of the Passport to Safer Birth tools addressed three domains: Care Mediator; Expectation Manager; and Pregnancy Assistant. CONCLUSION: The service design approach can create innovative, human-centered service solutions to improve maternity care experiences and outcomes in low-resource settings.

Healthcare providers' perspectives on labor monitoring in Nigeria and Uganda: A qualitative study on challenges and opportunities.

OBJECTIVE: To explore current practices, challenges, and opportunities in relation to monitoring labor progression, from the perspectives of healthcare professionals in low-resource settings. METHODS: Thematic analysis of qualitative data (in-depth interviews [IDIs] and focus group discussions [FDGs]) obtained from a purposive sample of healthcare providers and managers in selected health facilities in Nigeria and Uganda. RESULTS: A total of 70 IDIs and 16 FGDs with doctors, midwives, and administrators are included in this analysis. Labor monitoring encompasses a broad scope of care jointly provided by doctors and midwives. A range of contextual limitations was identified as barriers to monitoring labor progression, including staff shortages, lack of team cooperation, delays in responding to abnormal labor observations, suboptimal provider-patient dynamics, and limitations in partograph use. Perceived opportunities to improve current practices included streamlining clinical team cooperation, facilitating provider-client communication, encouraging women's uptake of offered care, bridging the gaps in the continuum of monitoring tasks between cadres, and improving skills in assessment of labor progress, and accuracy in its documentation. CONCLUSION: Healthcare providers face many challenges to effective monitoring of labor progress in low-resource settings. This analysis presents potential opportunities to improve labor monitoring practices and tools in these contexts.

A service concept and tools to improve maternal and newborn health in Nigeria and Uganda.

OBJECTIVE: The "Better Outcomes in Labor Difficulty" (BOLD) project used a service design process to design a set of tools to improve quality of care during childbirth by strengthening linkages between communities and health facilities in Nigeria and Uganda. This paper describes the Passport to Safer Birth concept and the tools developed as a result. METHODS: Service design methods were used to identify facilitators and barriers to quality care, and to develop human-centered solutions. The service design process had three phases: Research for Design, Concept Design, and Detail Design, undertaken in eight hospitals and catchment communities. RESULTS: The service concept "Better Beginnings" comprises three tools. The "Pregnancy Purse" provides educational information to women throughout pregnancy. The "Birth Board" is a visual communication tool that presents the labor and childbirth process. The "Family Pass" is a set of wearable passes for the woman and her supporter to facilitate communication of care preferences. CONCLUSION: The Better Beginnings service concept and tools form the basis for the promotion of access to information and knowledge acquisition, and could improve communication between the healthcare provider, the woman, and her family during childbirth.

Defining quality of care during childbirth from the perspectives of Nigerian and Ugandan women: A qualitative study.

OBJECTIVE: To explore what "quality of care" means to childbearing women in Nigeria and Uganda, as a means of ensuring that women's voices and opinions are prioritized when developing interventions to improve quality in maternity care provision. METHODS: Qualitative methods, with a purposive sample of women in Nigeria and Uganda. Participants were asked to define quality of care and to provide examples of when it was and was not provided. Thematic analysis was used to synthesize findings based on an a priori framework (the WHO quality of care framework). RESULTS: 132 in-depth interviews and 21 focus group discussions are included. Participants spontaneously discussed each of the WHO framework domains of quality of care. Data were richest across the domains of effective communication, respect and dignity, emotional support, competent and motivated human resources, and essential physical resources. Women believed that good quality of care ensured optimal psychological and physiological outcomes for the woman and her baby. Positive interpersonal relationships between women and health providers were important. These included supportive care, building rapport, and using positive and clear language. CONCLUSION: To provide good quality of care, maternity services should consider and act on the expectations and experiences of women and their families.

Negotiating quality standards for effective delivery of labor and childbirth care in Nigeria and Uganda.

OBJECTIVE: "Negotiated standards" describe a level of quality of care that is acceptable and achievable within a specific health system, based on consensus between key stakeholders. This paper presents the development of negotiated standards for effective labor and childbirth care in selected hospitals and communities in Nigeria and Uganda. METHODS: A four-step development process involving different methodologies. The process included: (1) review and synthesis of internationally recognized intrapartum clinical principles and practices; (2) primary qualitative research to assess values and preferences of women and healthcare providers, and practices that align with these preferences; (3) draft contextualization of effective and ineffective behaviors to reflect values and preferences; and (4) WHO-mediated negotiations between relevant stakeholders, including community members, providers, and administrators. RESULTS: The primary outcomes of this process were a comprehensive set of effective behaviors and clinical practices covering the main domains of quality of care, which are practical and easy to communicate, implement, and audit across all levels of healthcare delivery. CONCLUSION: The process demonstrates that health facilities and providers can be motivated to adopt standards of care that uphold the values and preferences of both service users and providers, while adhering to international best practices.

Low- and middle-income countries face many common barriers to implementation of maternal health evidence products.

OBJECTIVES: To explore similarities and differences in challenges to maternal health and evidence implementation in general across several low- and middle-income countries (LMICs) and to identify common and unique themes representing barriers to and facilitators of evidence implementation in LMIC health care settings. STUDY DESIGN: Secondary analysis of qualitative data. SETTING: Meeting reports and articles describing projects undertaken by the authors in five LMICs on three continents were analyzed. Projects focused on identifying barriers to and facilitators of implementation of evidence products: five World Health Organization maternal health guidelines, and a knowledge translation strategy to improve adherence to tuberculosis treatment. Data were analyzed using thematic content analysis. RESULTS: Among identified barriers to evidence implementation, a high degree of commonality was found across countries and clinical areas, with lack of financial, material, and human resources most prominent. In contrast, few facilitators were identified varied substantially across countries and evidence implementation products. CONCLUSION: By identifying common barriers and areas requiring additional attention to ensure capture of unique barriers and facilitators, these findings provide a starting point for development of a framework to guide the assessment of barriers to and facilitators of maternal health and potentially to evidence implementation more generally in LMICs.