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

Calcium supplementation to prevent pre-eclampsia: protocol for an individual participant data meta-analysis, network meta-analysis and health economic evaluation.
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DOI:
10.1136/bmjopen-2022-065538
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发表时间:
2023-05-11
期刊:
影响因子:
2.9
通讯作者:
International Calcium in Pregnancy (i-CIP) Collaborative Network
International Calcium in Pregnancy (i-CIP) Collaborative Network
中科院分区:
医学3区
文献类型:
--
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

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膳食钙摄入量低是子痫前期的一个危险因素,子痫前期是全世界孕产妇和围产期死亡率和发病率的一个主要因素。补钙可以预防饮食中钙含量低的妇女先兆子痫。然而,补钙的最佳剂量和时间尚不清楚。我们计划对随机试验进行个体参与者数据(IPD)荟萃分析,以确定各种补钙方案在预防先兆子痫及其并发症中的作用,并根据有效性对这些方案进行排名。我们还旨在评估补钙预防先兆子痫的成本效益。我们将通过检索Embase、CINAHL、MEDLINE、CENTRAL、PubMed、Scopus、AMED、LILACS、POPLINE、AIM、IMSEAR、ClinicalTrials.gov和WHO国际临床试验注册平台等主要电子数据库(无语言限制),从创建到2022年2月,确定孕前和孕期补钙的随机试验。确定的试验的主要研究人员将被邀请加入国际妊娠钙协作网络并分享他们的IPD。在标准化和协调数据之前,我们将检查每项研究的IPD与原作者的一致性。我们将进行一系列一期和两期IPD随机效应荟萃分析,以获得95% ci的综合干预对先兆子痫的影响,以及综合治疗-协变量相互作用(产妇风险状况、饮食摄入、干预时间、每日钙处方剂量和钙总摄入量)。在一项新的研究中,异质性将使用tau2、I2和95%的预测区间来总结。将进行敏感性分析以探索统计和临床假设的稳健性。次要的研究影响(潜在的发表偏倚)将使用漏斗图进行调查。一个用于低收入和中等收入国家的决策分析模型将评估补充钙预防先兆子痫的成本效益。不需要伦理批准。我们将以匿名格式将数据存储在安全存储库中。研究结果将发表在同行评议的期刊上。CRD42021231276。
Low dietary calcium intake is a risk factor for pre-eclampsia, a major contributor to maternal and perinatal mortality and morbidity worldwide. Calcium supplementation can prevent pre-eclampsia in women with low dietary calcium. However, the optimal dose and timing of calcium supplementation are not known. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to determine the effects of various calcium supplementation regimens in preventing pre-eclampsia and its complications and rank these by effectiveness. We also aim to evaluate the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. We will identify randomised trials on calcium supplementation before and during pregnancy by searching major electronic databases including Embase, CINAHL, MEDLINE, CENTRAL, PubMed, Scopus, AMED, LILACS, POPLINE, AIM, IMSEAR, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform, without language restrictions, from inception to February 2022. Primary researchers of the identified trials will be invited to join the International Calcium in Pregnancy Collaborative Network and share their IPD. We will check each study’s IPD for consistency with the original authors before standardising and harmonising the data. We will perform a series of one-stage and two-stage IPD random-effect meta-analyses to obtain the summary intervention effects on pre-eclampsia with 95% CIs and summary treatment–covariate interactions (maternal risk status, dietary intake, timing of intervention, daily dose of calcium prescribed and total intake of calcium). Heterogeneity will be summarised using tau2, I2 and 95% prediction intervals for effect in a new study. Sensitivity analysis to explore robustness of statistical and clinical assumptions will be carried out. Minor study effects (potential publication bias) will be investigated using funnel plots. A decision analytical model for use in low-income and middle-income countries will assess the cost-effectiveness of calcium supplementation to prevent pre-eclampsia. No ethical approvals are required. We will store the data in a secure repository in an anonymised format. The results will be published in peer-reviewed journals. CRD42021231276.
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