Calcium supplementation to prevent pre-eclampsia in Low- and Middle-Income Countries: IPD meta-analysis, network meta-analysis and economic evaluation

低收入和中等收入国家补充钙预防先兆子痫：IPD 荟萃分析、网络荟萃分析和经济评估

• 批准号: MR/T038861/1
• 负责人: Shakila Thangaratinam
• 金额: $ 67.66万
• 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: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT038861%2F1
• 关键词: Calcium; supplementation; prevent; pre; eclampsia

WHAT IS THE PROBLEM?Pre-eclampsia, a condition in pregnancy associated with high blood pressure and protein in the urine, is a major cause of avoidable deaths in mothers and babies, particularly in low and middle-income countries. Calcium supplements in pregnancy could prevent pre-eclampsia and potentially save 21,500 mothers every year from dying in these countries. Although calcium is on the national essential medicines list of these countries, and the World Health Organization (WHO) recommends high-dose calcium (>1.5g/day) to prevent pre-eclampsia, calcium deficiency in pregnancy continues to be a major preventable public health challenge. We can attribute this to the reluctance of mothers to take large, unpalatable high-dose calcium tablets 3-times a day that is often associated with side effects such as vomiting and constipation. Furthermore, large numbers of bulky tablets pose logistical difficulties with transport and storage, limiting their availability in rural areas. The healthcare professionals also have concerns about the large calcium doses affecting the absorption of iron needed to treat anaemia. WHAT NEEDS TO BE DONE?There is an urgent need for us to identify a) the group of women who will benefit the most from calcium supplementation (based on individual characteristics) b) the most effective and acceptable minimal dose of calcium, and c) the best time to start the supplement to prevent pre-eclampsia and complications. Policymakers and healthcare professionals also need information on the barriers to the uptake of calcium and its implementation, and the cost implications of supplementation within limited healthcare resources.WHAT HAS BEEN DONE SO FAR?To-date, despite over 30,000 women participating in numerous studies on calcium supplementation to prevent pre-eclampsia, we were able to answer the above questions due to differences in the characteristics of women, the dosage and timing of calcium in these studies. Our international collaborative network (i-CIP) has established a partnership between researchers from low, middle- and high-income countries who conducted the above studies, WHO guideline developers, and experts on calcium supplementation in pregnancy to answer the gaps in research.WHAT DO WE PLAN TO DO?In this proposal, we plan to combine the data from individuals who participated in studies on calcium supplementation by a technique called 'IPD meta-analysis' to determine if the effects of calcium differed between different groups of women, and if it varied according to the dose and duration of calcium use. We will obtain the views of mothers and healthcare professionals through surveys and interviews on what they consider may hinder the uptake and use of the calcium supplementation strategy that we find to be most effective. We will study the costs of calcium supplementation against the costs saved in low- and middle-income countries by avoiding pre-eclampsia and its complications. This economic model will be provided in a format that can be used by experts in other countries to determine the relevant economic impact. Research capacity strengthening of our partners is the key to the long-term sustainability of the project. WHAT DO WE EXPECT WILL HAPPEN?We expect our findings to lead to an update of the existing WHO guidelines on calcium supplementation in pregnancy, inform policymakers on optimal strategies and costs to promote calcium supplementation, reduce calcium deficiency in pregnant women, and improve outcomes for mother and baby by preventing pre-eclampsia. We planned this proposal in partnership with the patient and public involvement groups so that women are involved in the co-development of the study and dissemination. Our collaboration with WHO (Reproductive health, Nutrition, Human Reproduction Programme HRP Alliance) is key to the development and dissemination of our work through guidelines and existing networks.

有什么问题吗？先兆子痫是一种与高血压和尿中蛋白质有关的妊娠状况，是母亲和婴儿可避免死亡的一个主要原因，特别是在低收入和中等收入国家。在这些国家，怀孕期间补充钙可以预防先兆子痫，每年有可能挽救2.15万名母亲的生命。虽然钙被列入这些国家的国家基本药物清单，世界卫生组织（世卫组织）建议高剂量钙（1.5g/天）来预防先兆子痫，但孕期缺钙仍然是一个主要的可预防的公共卫生挑战。我们可以把这归因于母亲们不愿意每天三次服用大剂量的、难以下咽的高剂量钙片，这通常伴随着呕吐和便秘等副作用。此外，大量笨重的药片在运输和储存方面造成后勤困难，限制了农村地区的供应。医疗保健专业人员还担心，大剂量的钙会影响治疗贫血所需的铁的吸收。需要做些什么？我们迫切需要确定a)哪组妇女将从补钙中获益最多（基于个体特征）b)最有效和可接受的最小钙剂量c)开始补钙以预防先兆子痫及其并发症的最佳时间。决策者和卫生保健专业人员还需要有关钙吸收障碍及其实施的信息，以及在有限的卫生保健资源下补充钙的成本影响。到目前为止做了什么？迄今为止，尽管有超过30,000名女性参与了大量关于补充钙以预防先兆子痫的研究，但由于这些研究中女性的特征、钙的剂量和时间的差异，我们能够回答上述问题。我们的国际合作网络（i-CIP）已经在进行上述研究的来自低收入、中等收入和高收入国家的研究人员、世卫组织指南的制定人员和妊娠期补钙专家之间建立了伙伴关系，以弥补研究中的空白。我们打算做什么？在本提案中，我们计划通过一种名为“IPD荟萃分析”的技术，将参与钙补充研究的个体数据结合起来，以确定钙的效果在不同组的女性之间是否存在差异，以及是否根据钙的剂量和使用时间而变化。我们将通过调查和访谈获得母亲和保健专业人员的意见，了解他们认为哪些因素可能阻碍我们认为最有效的钙补充策略的吸收和使用。我们将研究钙补充剂的成本与中低收入国家通过避免先兆子痫及其并发症而节省的成本的对比。这个经济模型将以其他国家的专家可以使用的格式提供，以确定有关的经济影响。加强合作伙伴的研究能力是项目长期可持续性的关键。我们期望会发生什么？我们希望我们的研究结果能够更新现有的世卫组织妊娠期补钙指南，为政策制定者提供促进补钙的最佳策略和成本，减少孕妇缺钙，并通过预防先兆子痫改善母婴结局。我们与患者和公众参与团体合作制定了这一建议，以便妇女参与研究和传播的共同发展。我们与世卫组织（生殖健康、营养、人类生殖规划HRP联盟）的合作是通过准则和现有网络发展和传播我们工作的关键。

项目成果

Calcium supplementation to prevent pre-eclampsia: protocol for an individual participant data meta-analysis, network meta-analysis and health economic evaluation.

• DOI: 10.1136/bmjopen-2022-065538
• 发表时间: 2023-05-11
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Rocha T;Allotey J;Palacios A;Vogel JP;Smits L;Carroli G;Mistry H;Young T;Qureshi ZP;Cormick G;Snell KIE;Abalos E;Pena-Rosas JP;Khan KS;Larbi KK;Thorson A;Singata-Madliki M;Hofmeyr GJ;Bohren M;Riley R;Betran AP;Thangaratinam S;International Calcium in Pregnancy (i-CIP) Collaborative Network
• 通讯作者: International Calcium in Pregnancy (i-CIP) Collaborative Network