Objective The Accelerating Innovation for Mothers project established a new database of candidate medicines under development between 2000 and 2021 for five pregnancy‐related conditions, including fetal growth restriction. The objective was to assess medicines for fetal growth restriction and their potential for clinical use globally. Design Landscape analysis. Setting Global (focus on low‐ and middle‐income countries, LMICs). Sample Drugs, dietary supplements and biologics under investigation for prevention or treatment of fetal growth restriction. Methods A research pipeline database of medicines was created through searching AdisInsight, PubMed and various grant and clinical trial databases. Analysis of clinical and preclinical candidates were descriptive. Main Outcomes Measures Fetal growth restriction candidates in clinical development were identified and ranked as high, medium or low potential based on prespecified criteria, including efficacy, safety and accessibility. Results Of the 444 unique candidates in the database across all five pregnancy‐related conditions, 63 were for fetal growth restriction. Of these, 31 were in clinical development (phases I, II or III) and 32 were in preclinical development. Three candidates, aspirin, l‐arginine and vitamin D, were ranked as having high potential as preventive agents. There were no high‐potential candidates for treating fetal growth restriction, although five candidates were ranked as having medium potential: allylestrenol, dalteparin, omega‐3 fatty acids, tadalafil, and United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). Conclusions l‐Arginine, aspirin and vitamin D are promising, high‐potential preventative agents for fetal growth restriction. Based on the medicines pipeline, new pharmacological agents for fetal growth restriction are unlikely to emerge in the near future.

ObjectiveTo check the quality of oxytocin and tranexamic acid—two recommended products for prevention and treatment of postpartum hemorrhage (PPH)—used in facilities taking part in an implementation research project to improve PPH diagnosis and management.MethodsBetween September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.ResultsOf the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.ConclusionWhile we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.

BackgroundA significant barrier to improving prevention and treatment of postpartum hemorrhage (PPH) is a lack of innovative medicines that meet the needs of women and providers, particularly those in low‐and middle‐income countries (LMICs). The Accelerating Innovation for Mothers (AIM) project established a new database of candidate medicines under development for five pregnancy‐related conditions between 2000 and 2021.ObjectiveTo systematically identify and rank candidates for prevention and treatment of PPH.Search StrategyAdis Insight, Pharmaprojects, WHO ICTRP, PubMed, and grant databases were searched to develop the AIM database.Selection CriteriaAIM database was searched for candidates being evaluated for PPH prevention and treatment, regardless of phase.Data Collection and AnalysisCandidates were ranked as high, medium, or low potential based on prespecified criteria. Analysis was primarily descriptive, describing candidates and development potential.Main ResultsOf the 444 unique candidates, only 39 pertained to PPH. One was high potential (heat‐stable/inhaled oxytocin) and three were medium potential (melatonin, vasopressin and dofetilide via nanoparticle delivery).ConclusionThe pipeline for new PPH medicines is concerningly limited, lacking diversity, and showing little evidence of novel technologies. Without significant investment in early‐phase research, it is unlikely that new products will emerge.

Despite the 2017 WHO recommendations on tranexamic acid (TXA) for the treatment of postpartum hemorrhage (PPH), the 2018 uterotonic recommendations (which included heat‐stable carbetocin (HSC) for the prevention of PPH) and their inclusion in the WHO Essential Medicines List (EML), both drugs are still underused or not used at all to manage PPH in many countries with a high burden. HSC is currently being registered in low‐ and middle‐income countries and its policy inclusion is limited and slow. TXA (also heat stable) is available in many countries but is not registered for PPH treatment, which may have contributed to the delay in its inclusion in national guidelines and EMLs. For both drugs, national guidelines will need to be revised and updated for their optimal uptake. We implemented an advocacy initiative to accelerate the necessary normative policy change to ensure access to quality‐assured and heat‐stable medicines for the prevention and treatment of PPH in Sub‐Saharan African countries. Our initiative aimed to raise awareness of the importance of recently recommended medicines for the prevention and treatment of PPH and support the process to update PPH guidelines and EMLs to include these drugs. We highlight the lessons learned during the initiative, including the challenges and opportunities identified in updating PPH policies at the national level.

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