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ObjectiveTo systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH).MethodsAn international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting.ResultsThe consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements.ConclusionFor the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real‐world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders. Design: Mixed methods. Setting: Global (with a focus on low‐ and middle‐income countries, LMICs). Sample Global stakeholders with diverse expertise in preterm labour/birth and drug development. Methods: Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in‐depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs. Main outcomes measures: Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines. Results: We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug‐specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree). Conclusions: There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings. [ABSTRACT FROM AUTHOR]

Abstract Background WHO develops evidence-based guidelines for setting global standards and providing technical support to its Member States and the international community, as a whole. There is a clear need to ensure that WHO guidance is relevant, rigorous and up-to date. A key activity is to ascertain the guidance needs of the countries. This study provides an international comparison of priority guidance needs for maternal and perinatal health. It incorporates data from those who inform policy and implementation strategies at a national level, in addition to targeting those who use and most need the guidance at grassroot level. Methods An online multi-country survey was used to identify WHO guidance priorities for the next five years in the field of maternal and perinatal health. WHO regional and country offices were requested to respond the survey and obtain responses from Ministries of Health around the world. In addition, the survey was disseminated through other networks and relevant electronic forums. Results A total of 393 responses were received, including 56 from Ministries of Health and 54 from WHO/UN country offices. 75% of responses were from developing countries and 25% from developed countries. Guidance on strategies focusing on 'quality of care' issues to reduce all-cause maternal/perinatal mortality was considered the most important domain to target, which includes for instance guidance to improve access, dissemination, implementation of effective practices and health professionals' education. Conclusions This study provides a panorama of international priority guidance needs for maternal and perinatal health. Although clinical guidance remains a priority, there are other areas related to health systems guidance, which seem to be even more important. Overall, the domain ranked highest in terms of greatest need for guidance was around quality of care, which included questions related to educational needs, access to and implementation of guidance.

Magnesium sulfate is the anticonvulsant of choice for eclampsia prophylaxis and treatment; however, the recommended dosing regimens are costly and cumbersome and can be administered only by skilled health professionals. The objectives of this study were to develop a robust exposure‐response model for the relationship between serum magnesium exposure and eclampsia using data from large studies of women with preeclampsia who received magnesium sulfate, and to predict eclampsia probabilities for standard and alternative (shorter treatment duration and/or fewer intramuscular injections) regimens. Exposure‐response modeling and simulation were applied to existing data. A total of 10 280 women with preeclampsia who received magnesium sulfate or placebo were evaluated. An existing population pharmacokinetic model was used to estimate individual serum magnesium exposure. Logistic regression was applied to quantify the serum magnesium area under the curve‐eclampsia rate relationship. Our exposure‐response model‐estimated eclampsia rates were comparable to observed rates. Several alternative regimens predicted magnesium peak concentration < 3.5 mmol/L (empiric safety threshold) and eclampsia rate ≤ 0.7% (observed response threshold), including 4 g intravenously plus 10 g intramuscularly followed by either 8 g intramuscularly every 6 hours × 3 doses or 10 g intramuscularly every 8 hours × 2 doses and 10 g intramuscularly every 8 hours × 3 doses. Several alternative magnesium sulfate regimens with comparable model‐predicted efficacy and safety were identified that merit evaluation in confirmatory clinical trials. [ABSTRACT FROM AUTHOR]

Elective labor induction is an increasingly common practice not only in high-income countries, but also in many low-income and middle-income countries. Many questions remain unanswered on the safety and cost-effectiveness of elective labor induction, particularly in resource-constrained settings where there may be a high unmet need for medically indicated inductions, as well as limited or no access to appropriate medications and equipment for induction and monitoring, comprehensive emergency obstetric care, safe and timely cesarean section, and appropriate supervision from health professionals. This article considers the global perspective on the epidemiology, practices, safety, and costs associated with elective labor induction. [ABSTRACT FROM AUTHOR]

Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real-world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders., Design: Mixed methods., Setting: Global (with a focus on low- and middle-income countries, LMICs)., Sample: Global stakeholders with diverse expertise in preterm labour/birth and drug development., Methods: Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in-depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs., Main Outcomes Measures: Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines., Results: We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug-specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree)., Conclusions: There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings., (© 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)