Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis.
Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis.
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二甲双胍妊娠研究 (MiPS)：通过个体患者数据荟萃分析进行系统评价的方案。
DOI：
10.1136/bmjopen-2020-036981
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发表时间：
2020
期刊：
影响因子：
2.9
通讯作者：
Mousa A
中科院分区：
文献类型：
--
作者：
Mousa A
妊娠期糖尿病（GDM）是一种常见的妊娠疾病，可导致不良妊娠结局。二甲双胍常用于预防和管理GDM；然而，它在怀孕中的使用仍然存在争议。妊娠期二甲双胍研究旨在使用个体患者数据（IPD）荟萃分析来阐明妊娠期使用二甲双胍的有效性和安全性，并确定相关知识空白。方法和分析medline、EMBASE和所有循证医学将被系统地检索随机对照试验（RCT），测试二甲双胍与安慰剂、常规护理或其他干预措施对孕妇的疗效。两名独立审稿人将使用预先指定的标准评估合格性，并将对合格研究进行数据提取和质量评估。纳入试验的作者将被联系并要求提供IPD。主要结局包括产妇血糖参数和GDM，以及新生儿低血糖、人体测量和分娩时的胎龄。其他不良的产妇、分娩和新生儿结局将作为次要结局进行评估。这些随机对照试验的IPD将被统一，两步荟萃分析方法将用于确定二甲双胍在妊娠期的有效性和安全性，并对协变量和亚组进行先验调整，以检查治疗结果的效果调节因子。敏感性分析将评估异质性、偏倚风险和未提供IPD的试验的影响。伦理和传播所有IPD将被确定，贡献IPD的研究将得到各自当地伦理委员会的伦理批准。这项研究将为妊娠期使用二甲双胍的有效性和安全性提供强有力的证据，并可能确定从这种治疗方式中获益最多的患者亚组。研究结果将发表在同行评议的期刊上，并在科学会议上传播，为这一领域的临床和公共卫生行动提供急需的证据。
IntroductionGestational diabetes mellitus (GDM) is a common disorder of pregnancy and contributes to adverse pregnancy outcomes. Metformin is often used for the prevention and management of GDM; however, its use in pregnancy continues to be debated. The Metformin in Pregnancy Study aims to use individual patient data (IPD) meta-analysis to clarify the efficacy and safety of metformin use in pregnancy and to identify relevant knowledge gaps.Methods and analysisMEDLINE, EMBASE and all Evidence-Based Medicine will be systematically searched for randomised controlled trials (RCT) testing the efficacy of metformin compared with placebo, usual care or other interventions in pregnant women. Two independent reviewers will assess eligibility using prespecified criteria and will conduct data extraction and quality appraisal of eligible studies. Authors of included trials will be contacted and asked to contribute IPD. Primary outcomes include maternal glycaemic parameters and GDM, as well as neonatal hypoglycaemia, anthropometry and gestational age at delivery. Other adverse maternal, birth and neonatal outcomes will be assessed as secondary outcomes. IPD from these RCTs will be harmonised and a two-step meta-analytic approach will be used to determine the efficacy and safety of metformin in pregnancy, with a priori adjustment for covariates and subgroups to examine effect moderators of treatment outcomes. Sensitivity analyses will assess heterogeneity, risk of bias and the impact of trials which have not provided IPD.Ethics and disseminationAll IPD will be deidentified and studies contributing IPD will have ethical approval from their respective local ethics committees. This study will provide robust evidence regarding the efficacy and safety of metformin use in pregnancy, and may identify subgroups of patients who may benefit most from this treatment modality. Findings will be published in peer-reviewed journals and disseminated at scientific meetings, providing much needed evidence to inform clinical and public health actions in this area.