Development, Field-Testing and Piloting of a refractory postpartum haemorrhage management package: the PPH ReAct (PPH Refractory Action) study

难治性产后出血管理方案的开发、现场测试和试点：PPH ReAct（PPH 难治行动）研究

• 批准号: MR/T038985/1
• 负责人: Arri Coomarasamy
• 金额: $ 106.56万
• 依托单位: University of Birmingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT038985%2F1
• 关键词: Development; Field; Testing; Piloting; refractory

Every six minutes a mother dies from excessive bleeding after childbirth in low-resource countries, in the prime of her life and often leaving behind a young family. When a mother dies in childbirth, her infant has less than a 20% chance of surviving past the first month. Excessive bleeding after childbirth, or postpartum haemorrhage (PPH), is the commonest reason why mothers die worldwide. Effective treatment can stop bleeding in most women. However, those who continue to bleed despite 'first response' treatment are thought to have refractory PPH and are the women who die or suffer major complications. We have developed a provisional management package for these women, called the 'PPH ReAct' package. We wish to refine this management package, develop an implementation strategy for this, field-test these and finally pilot the approach in 5 health facilities in Kenya. The WHO published "Recommendations for the Prevention and Treatment of Postpartum Hemorrhage" in 2012 to provide evidence-informed recommendations for managing PPH. However, adherence to these recommendations is currently limited by a number of challenges. Challenges and proposed solutions 1) Many women continue to bleed despite 'first response' management of PPH --> Solution: A refractory PPH treatment package 2) Delayed or inconsistent use of treatments for refractory PPH management --> Solution: A refractory PPH management (the PPH ReAct) package that uses simplified approaches and a checklist to ensure consistent and timely assessments and treatments. 3) Many care providers and organisations struggle to provide effective care for women with refractory PPH, despite treatments being available --> Solution: Deeper understanding of challenges, and a strategy for changing behaviours of healthcare professionals and organisations using behavioural science frameworks. 4) Lack of evidence and confidence that the proposed approach can improve usage of effective treatments for treatment of refractory PPH --> Solution: A study for the refractory PPH treatment package to ensure an increase usage of life-saving treatment by the healthcare professionals and organisations. This study could generate the necessary evidence that will give healthcare practitioners and policy makers the confidence to implement and scale-up the programme.5) Limited scale-up and coverage --> Solution: Engagement of strong partners: World Health Organisation, Jhpiego, Behavioural Scientists, Health Ministries and Concept FoundationOur aim is to develop, refine and evaluate an effective approach to managing refractory PPH. Despite concentrated efforts, PPH remains the leading cause why mothers die or suffer major complications during childbirth. Most women with PPH respond to initial treatments. However, a substantial number of women do not, and these are the women who suffer die or suffer major complications. There is an unmet need to define the optimal approach for managing refractory PPH. Furthermore, a management approach could achieve its intended goals only if it is widely accepted and used in everyday practice; thus a meaningful strategy for implementing this approach is necessary. We therefore propose the development, refinement and piloting of a refractory PPH management package and implementation strategy.

在资源匮乏的国家，每6分钟就有一名母亲在生命的黄金时期死于分娩后大出血，往往留下一个年轻的家庭。当一位母亲死于分娩时，她的婴儿只有不到20%的机会活过第一个月。分娩后大出血或产后出血（PPH）是全世界母亲死亡的最常见原因。有效的治疗可以使大多数妇女止血。然而，那些在“第一反应”治疗后仍持续出血的妇女被认为患有难治性PPH，并且是死亡或遭受主要并发症的妇女。我们为这些女性开发了一个临时管理包，称为“PPH ReAct”包。我们希望完善这一一揽子管理方案，为此制定一项实施战略，对这些方案进行实地测试，并最终在肯尼亚的5个卫生设施中试点这一方法。世卫组织于2012年发布了“预防和治疗产后出血建议”，为管理PPH提供循证建议。然而，遵守这些建议目前受到一些挑战的限制。挑战和建议的解决方案1)尽管PPH“第一反应”管理->解决方案：难治性PPH治疗方案2)难治性PPH治疗方案的延迟或不一致使用->解决方案：难治性PPH管理（PPH ReAct）方案，使用简化的方法和清单来确保一致和及时的评估和治疗。3)许多护理提供者和组织努力为难治性PPH妇女提供有效的护理，尽管有治疗方法——>解决方案：更深入地了解挑战，以及使用行为科学框架改变医疗保健专业人员和组织行为的策略。4)缺乏证据和信心，所提出的方法可以提高难治性PPH治疗的有效治疗方法的使用——>解决方案：难治性PPH治疗方案的研究，以确保医疗保健专业人员和组织增加救命治疗的使用。这项研究可以产生必要的证据，将给医疗从业者和政策制定者的信心，以实施和扩大计划。5)有限的扩大和覆盖->解决方案：强有力的合作伙伴的参与：世界卫生组织，Jhpiego，行为科学家，卫生部和概念基金会我们的目标是开发，完善和评估一种有效的方法来管理难治性PPH。尽管进行了集中的努力，PPH仍然是母亲在分娩期间死亡或遭受重大并发症的主要原因。大多数患有PPH的妇女对最初的治疗有反应。然而，相当数量的妇女没有这样做，这些妇女死亡或患有严重并发症。有一个未满足的需要来定义管理难治性PPH的最佳方法。此外，管理方法只有在日常实践中得到广泛接受和使用，才能实现其预期目标；因此，有必要制定一项有意义的战略来实施这一办法。因此，我们建议开发、完善和试点一个难熔PPH管理包和实施策略。

项目成果

Objective Measurement of Blood Loss following Vaginal Delivery in a UK Hospital

英国一家医院阴道分娩后失血量的客观测量

• DOI: 10.31083/j.ceog5011236
• 发表时间: 2023
• 期刊: Clinical and Experimental Obstetrics & Gynecology
• 影响因子: 0.2
• 作者: Coomarasamy A

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

• DOI: 10.1056/nejmoa2303966
• 发表时间: 2023-05-09
• 期刊: NEW ENGLAND JOURNAL OF MEDICINE
• 影响因子: 158.5
• 作者: Gallos, Ioannis;Devall, Adam;Coomarasamy, Arri
• 通讯作者: Coomarasamy, Arri

Interim data monitoring in cluster randomised trials: Practical issues and a case study.

• DOI: 10.1177/17407745211024751
• 发表时间: 2021-10
• 期刊: Clinical trials (London, England)
• 作者: Hemming K;Martin J;Gallos I;Coomarasamy A;Middleton L
• 通讯作者: Middleton L

Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.

• DOI: 10.1186/s12978-021-01162-3
• 发表时间: 2021-07-14
• 期刊: Reproductive health
• 影响因子: 3.4
• 作者: Bohren MA;Lorencatto F;Coomarasamy A;Althabe F;Devall AJ;Evans C;Oladapo OT;Lissauer D;Akter S;Forbes G;Thomas E;Galadanci H;Qureshi Z;Fawcus S;Hofmeyr GJ;Al-Beity FA;Kasturiratne A;Kumarendran B;Mammoliti KM;Vogel JP;Gallos I;Miller S
• 通讯作者: Miller S

Detection and management of postpartum haemorrhage: Qualitative evidence on healthcare providers' knowledge and practices in Kenya, Nigeria, and South Africa.

• DOI: 10.3389/fgwh.2022.1020163
• 发表时间: 2022
• 期刊: FRONTIERS IN GLOBAL WOMENS HEALTH
• 作者: Akter, Shahinoor;Forbes, Gillian;Miller, Suellen;Galadanci, Hadiza;Qureshi, Zahida;Fawcus, Sue;Hofmeyr, G. Justus;Moran, Neil;Singata-Madliki, Mandisa;Amole, Taiwo Gboluwaga;Gwako, George;Osoti, Alfred;Thomas, Eleanor;Gallos, Ioannis;Mammoliti, Kristie-Marie;Coomarasamy, Arri;Althabe, Fernando;Lorencatto, Fabiana;Bohren, Meghan A.
• 通讯作者: Bohren, Meghan A.