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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., (© 2019 World Health Organization; licensed by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

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., (© 2018 World Health Organization; licensed by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

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., (© 2017 International Federation of Gynecology and Obstetrics. The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.)

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., (© 2017 International Federation of Gynecology and Obstetrics. The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.)

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., (© 2017 International Federation of Gynecology and Obstetrics. The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.)

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., (© 2017 International Federation of Gynecology and Obstetrics. The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.)

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., (© 2017 International Federation of Gynecology and Obstetrics The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.)

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth., Methods/design: Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons., Discussion: If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide., Trial Registration: ACTRN12614000870651 (14 August 2014).