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Background Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization’s global recommendations on ACS use. Trial registration ACTRN12617000476336. Registered on 31 March 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3488-z) contains supplementary material, which is available to authorized users.

BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. Fil: Oladapo, Olufemi T.. Organizacion Mundial de la Salud; Argentina Fil: Vogel, Joshua P.. Organizacion Mundial de la Salud; Argentina Fil: Piaggio, Gilda. Organizacion Mundial de la Salud; Argentina Fil: Nguyen, My-Huong. Organizacion Mundial de la Salud; Argentina Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Metin Gülmezoglu, A.. Organizacion Mundial de la Salud; Argentina Fil: Bahl, Rajiv. Organizacion Mundial de la Salud; Argentina Fil: Rao, Suman P.N.. Organizacion Mundial de la Salud; Argentina Fil: de Costa, Ayesha. Organizacion Mundial de la Salud; Argentina Fil: Gupta, Shuchita. Organizacion Mundial de la Salud; Argentina Fil: Shahidullah, Mohammod. No especifíca; Fil: Chowdhury, Saleha B.. No especifíca; Fil: Ara, Gulshan. No especifíca; Fil: Akter, Shaheen. No especifíca; Fil: Akhter, Nasreen. No especifíca; Fil: Dey, Probhat R.. No especifíca; Fil: Abdus Sabur, M.. No especifíca; Fil: Azad, Mohammad T.. No especifíca; Fil: Choudhury, Shahana F.. No especifíca; Fil: Matin, M.A.. No especifíca; Fil: Goudar, Shivaprasad S.. No especifíca; Fil: Dhaded, Sangappa M.. No especifíca; Fil: Metgud, Mrityunjay C.. No especifíca; Fil: Pujar, Yeshita V.. No especifíca; Fil: Somannavar, Manjunath S.. No especifíca; Fil: Vernekar, Sunil S.. No especifíca; Fil: Herekar, Veena R.. No especifíca; Fil: Bidri, Shailaja R.. No especifíca; Fil: Mathapati, Sangamesh S.. No especifíca; Fil: Patil, Preeti G.. No especifíca; Fil: Patil, Mallanagouda M.. No especifíca; Fil: Gudadinni, Muttappa R.. No especifíca; Fil: Bijapure, Hidaytullah R.. No especifíca; Fil: Mallapur, Ashalata A.. No especifíca; Fil: Katageri, Geetanjali M.. No especifíca; Fil: Chikkamath, Sumangala B.. No especifíca; Fil: Yelamali, Bhuvaneshwari C.. No especifíca; Fil: Pol, Ramesh R.. No especifíca; Fil: Misra, Sujata S.. No especifíca; Fil: Das, Leena. No especifíca

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 Plain English summary 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.

IntroductionComplications 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.MethodsA 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.ResultsThere 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%).ConclusionThere 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.

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 underwe...

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.

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.

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.

Objective To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH). Design Secondary analysis of the WHO CHAMPION trial data. Setting Twenty‐three hospitals in ten countries. Population Women from the CHAMPION trial who received uterotonics as first‐line treatment of PPH. Methods We assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first‐line PPH treatment. Main outcome measures Maternal characteristics; causes of PPH. Results Women with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07–1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34–2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04–1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively. Conclusion Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first‐line treatment responsive PPH. Tweetable abstract Women with refractory postpartum haemorrhage are different from those with first‐line treatment responsive PPH., Tweetable abstract Women with refractory postpartum haemorrhage are different from those with first‐line treatment responsive PPH.

Additional file 1: Table S1. Description of the fixed variables considered in the bivariate analysis step Table S2. Description of the dynamic variables considered in the bivariate analysis Table S3. Description of variables recorded throughout the labour considered in the univariate analysis Table S4. P-value for Hosmer-Lemeshow test in each of the estimated models Figure S1. Analysis flow diagram Figure S2. ROC curves for models in the training sample (left column) and test sample (right column).

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.

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., In a prospective cohort study, Olufemi Oladapo and colleagues investigated cervical dilation progression during the first stage of spontaneous labor in women from Nigeria and Uganda., Author summary Why was this study done? Dr Emmanuel Friedman’s studies on normal and abnormal labour progression have defined how labour should be managed since the mid-1950s until today. Although Friedman’s studies were conducted among pregnant women in the United States, the general belief that labour progression is the same in humans led to universal application of their findings, and the expectation that the cervix dilates by at least 1 cm/hour in all women during established labour. Since the early 2000s, however, researchers using new statistical methods to study labour found evidence to suggest that the patterns of labour progression as described by Friedman may not be accurate for the current generation of women giving birth. While these newer findings have informed changes in recommended labour practices in some settings, they have also generated a lot of controversy. As a result of persistent questions as to whether racial characteristics influence labour progression patterns, recent studies have been conducted among different populations, but not yet in any African population. What did the researchers do and find? We conducted an analysis of prospectively collected observational data of 5,606 women who presented in early labour (at or before 6 cm of cervical dilatation) following spontaneous labour onset and gave birth vaginally in 13 maternity hospitals in Nigeria and Uganda. None of these women experienced serious adverse outcomes for themselves or their babies. We applied advanced statistical and computational methods (survival analysis and Markov techniques) to determine how long it took the cervix to dilate by 1 cm from one level of dilatation to the next until full dilatation (10 cm) and how long it took the cervix to reach full dilatation based on the dilatation at the time of labour admission. We also used two separate methods to plot population average cervical dilatation time curves (labour curves) for the women in our sample. Contrary to the generally held view, we found that labour progressed more slowly in our study population than previously reported. On average, the rate of cervical dilatation was less than 1 cm/hour for some women until 5 cm of cervical dilatation was reached among those undergoing their first, second, or subsequent labours. Labour was very slow in some women throughout the first stage, including the early part of the period that is traditionally known as the ‘active phase’, when the ‘normal’ cervical dilatation rate is expected to be at least 1 cm/hour or faster. While on average the labour progression in first-time mothers was generally similar to their counterparts in the US, China, and Japan, there are also important differences in the slowest-yet-normal (95th percentile) group of women in our study population. What do these findings mean? The average labour curves derived from our study population are substantially different from those published from the pioneer work of Friedman. They also do not truly reflect the variations shown in the labour progression of individual women in our study. The application of population average labour curves could potentially misclassify women who are slowly but normally progressing as abnormal and therefore increase their chances of being subjected to unnecessary labour interventions. We propose that averaged labour progression lines or curves are not used for decision-making in the management of labour for individual women. As labour may not naturally accelerate in some women until a cervical dilatation of 5 cm is reached, labour practices to address perceived slow labour progression should not be routinely applied by clinicians until this threshold is achieved, provided the vital signs and other observations of the mother and baby are normal. In the absence of any problems other than a slower than expected cervical dilatation rate (i.e., 1 cm/hour) during labour, it is in the interest of the woman that expectant, supportive, and woman-centred labour care is continued.

Objective To assess the accuracy of the World Health Organization (WHO) partograph alert line and other candidate predictors in the identification of women at risk of developing severe adverse birth outcomes. Design A facility‐based, multicentre, prospective cohort study. Setting Thirteen maternity hospitals located in Nigeria and Uganda. Population A total of 9995 women with spontaneous onset of labour presenting at cervical dilatation of ≤6 cm or undergoing induction of labour. Methods Research assistants collected data on sociodemographic, anthropometric, obstetric, and medical characteristics of study participants at hospital admission, multiple assessments during labour, and interventions during labour and childbirth. The alert line and action line, intrapartum monitoring parameters, and customised labour curves were assessed using sensitivity, specificity, positive and negative likelihood ratios, diagnostic odds ratio, and the J statistic. Outcomes Severe adverse birth outcomes. Results The rate of severe adverse birth outcomes was 2.2% (223 women with severe adverse birth outcomes), the rate of augmentation of labour was 35.1% (3506 women), and the caesarean section rate was 13.2% (1323 women). Forty‐nine percent of women in labour crossed the alert line (4163/8489). All reference labour curves had a diagnostic odds ratio ranging from 1.29 to 1.60. The J statistic was less than 10% for all reference curves. Conclusions Our findings suggest that labour is an extremely variable phenomenon, and the assessment of cervical dilatation over time is a poor predictor of severe adverse birth outcomes. The validity of a partograph alert line based on the ‘one‐centimetre per hour’ rule should be re‐evaluated. Funding Bill & Melinda Gates Foundation, United States Agency for International Development (USAID), UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), and WHO (A65879). Tweetable abstract The alert line in check: results from a WHO study., Tweetable abstract The alert line in check: results from a WHO study.

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.

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.

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.

Objective To characterise the current clinical practice patterns regarding the use of magnesium sulphate (MgSO4 ) for eclampsia prevention and treatment in a multi-country network of health facilities and compare with international recommendations. Design Cross-sectional survey. Setting A total of 147 health facilities in 15 countries across Africa, Latin America and Asia. Population Heads of obstetric departments or maternity units. Methods Anonymous online and paper-based survey conducted in 2015. Main outcome measures Availability and use of MgSO4 ; availability of a formal clinical protocol for MgSO4 administration; and MgSO4 dosing regimens for eclampsia prevention and treatment. Results Magnesium sulphate and a formal protocol for its administration were reported to be always available in 87.4% and 86.4% of all facilities, respectively. MgSO4 was used for the treatment of mild pre-eclampsia, severe pre-eclampsia and eclampsia in 24.3%, 93.5% and 96.4% of all facilities, respectively. Regarding the treatment of severe pre-eclampsia, 26.4% and 7.0% of all facilities reported using dosing regimens that were consistent with Zuspan and Pritchard regimens, respectively. Across regions, intramuscular maintenance regimens were more commonly used in the African region (45.7%) than in the Latin American (3.0%) and Asian (22.9%) regions, whereas intravenous maintenance regimens were more often used in the Latin American (94.0%) and Asian (60.0%) regions than in the African region (21.7%). Similar patterns were found for the treatment of eclampsia across regions. Conclusions The reported clinical use of MgSO4 for eclampsia prevention and treatment varied widely, and was largely inconsistent with current international recommendations. Tweetable abstract MgSO4 regimens for eclampsia prevention and treatment in many hospitals are inconsistent with international recommendations.

Background Health systems often fail to use evidence in clinical practice. In maternal and perinatal health, the majority of maternal, fetal and newborn mortality is preventable through implementing effective interventions. To meet this challenge, WHO’s Department of Reproductive Health and Research partnered with the Knowledge Translation Program at St. Michael’s Hospital (SMH), University of Toronto, Canada to establish a collaboration on knowledge translation (KT) in maternal and perinatal health, called the GREAT Network (Guideline-driven, Research priorities, Evidence synthesis, Application of evidence, and Transfer of knowledge). We applied a systematic approach incorporating evidence and theory to identifying barriers and facilitators to implementation of WHO maternal heath recommendations in four lower-income countries and to identifying implementation strategies to address these. Methods We conducted a mixed-methods study in Myanmar, Uganda, Tanzania and Ethiopia. In each country, stakeholder surveys, focus group discussions and prioritization exercises were used, involving multiple groups of health system stakeholders (including administrators, policymakers, NGOs, professional associations, frontline healthcare providers and researchers). Results Despite differences in guideline priorities and contexts, barriers identified across countries were often similar. Health system level factors, including health workforce shortages, and need for strengthened drug and equipment procurement, distribution and management systems, were consistently highlighted as limiting the capacity of providers to deliver high-quality care. Evidence-based health policies to support implementation, and improve the knowledge and skills of healthcare providers were also identified. Stakeholders identified a range of tailored strategies to address local barriers and leverage facilitators. Conclusion This approach to identifying barriers, facilitators and potential strategies for improving implementation proved feasible in these four lower-income country settings. Further evaluation of the impact of implementing these strategies is needed.

Rationale for the choice of the non-inferiority trial the choice of the non-inferiority trial [20-22]. (DOCX 24 kb)

Countries ethics committees list and status of the project approval request. (DOCX 15 kb)

Objective To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor. Methods The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 μg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth. Results The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38–1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred. Conclusion The present study did not confirm a beneficial effect of administering 400 μg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects. Trial registered on clinical trials.gov: NCT 00124540.

OBJECTIVE: To set up a global system for monitoring maternal and perinatal health in 54 countries worldwide. METHODS: The WHO Global Survey for Monitoring Maternal and Perinatal Health was implemented through a network of health institutions, selected using a stratified multistage cluster sampling design. Focused information on maternal and perinatal health was abstracted from hospital records and entered in a specially developed online data management system. Data were collected over a two- to three-month period in each institution. The project was coordinated by WHO and supported by WHO regional offices and country coordinators in Africa and the Americas. FINDINGS: The initial survey was implemented between September 2004 and March 2005 in the African and American regions. A total of 131 institutions in seven African countries and 119 institutions in eight Latin American countries participated. CONCLUSION: This project has created a technologically simple and scientifically sound system for large-scale data management, which can facilitate programme monitoring in countries.

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.

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. 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. 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 ’.

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.\ud 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.

Objective To assess the association between cesarean delivery rates and pregnancy outcomes in African health facilities. Methods Data were obtained from all births over 2–3 months in 131 facilities. Outcomes included maternal deaths, severe maternal morbidity, fresh stillbirths, and neonatal deaths and morbidity. Results Median cesarean delivery rate was 8.8% among 83 439 births. Cesarean deliveries were performed in only 95 (73%) facilities. Facility-specific cesarean delivery rates were influenced by previous cesarean, pre-eclampsia, induced labor, referral status, and higher health facility classification scores. Pre-eclampsia increased the risks of maternal death, fresh stillbirths, and severe neonatal morbidity. Adjusted emergency cesarean delivery rate was associated with more fresh stillbirths, neonatal deaths, and severe neonatal morbidity—probably related to prolonged labor, asphyxia, and sepsis. Adjusted elective cesarean delivery rate was associated with fewer perinatal deaths. Conclusion Use of cesarean delivery is limited in the African health facilities surveyed. Emergency cesareans, when performed, are often too late to reduce perinatal deaths.

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 ’.

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’. Electronic supplementary material The online version of this article (doi:10.1186/s12978-015-0029-4) contains supplementary material, which is available to authorized users.