Rodger Marc A, Langlois Nicole J, de Vries Johanna Ip, Rey Evelyne, Gris Jean-Christophe, Martinelli Ida, Schleussner Ekkehard, Ramsay Timothy, Mallick Ranjeeta, Skidmore Becky, Middeldorp Saskia, Bates Shannon, Petroff David, Bezemer Dick, van Hoorn Marion E, Abheiden Carolien Nh, Perna Annalisa, de Jong Paulien, Kaaja Risto
The Ottawa Hospital, Centre for Practice-Changing Research, 501 Smyth Road, Box 201, Ottawa, ON K1H 8 L6, Canada.
Syst Rev. 2014 Jun 26;3:69. doi: 10.1186/2046-4053-3-69.
Placenta-mediated pregnancy complications include pre-eclampsia, late pregnancy loss, placental abruption, and the small-for-gestational age newborn. They are leading causes of maternal, fetal, and neonatal morbidity and mortality in developed nations. Women who have experienced these complications are at an elevated risk of recurrence in subsequent pregnancies. However, despite decades of research no effective strategies to prevent recurrence have been identified, until recently. We completed a pooled summary-based meta-analysis that strongly suggests that low-molecular-weight heparin reduces the risk of recurrent placenta-mediated complications. The proposed individual patient data meta-analysis builds on this successful collaboration. The project is called AFFIRM, An individual patient data meta-analysis oF low-molecular-weight heparin For prevention of placenta-medIated pRegnancy coMplications.
METHODS/DESIGN: We conducted a systematic review to identify randomized controlled trials with a low-molecular-weight heparin intervention for the prevention of recurrent placenta-mediated pregnancy complications. Investigators and statisticians representing eight trials met to discuss the outcomes and analysis plan for an individual patient data meta-analysis. An additional trial has since been added for a total of nine eligible trials. The primary analyses from the original trials will be replicated for quality assurance prior to recoding the data from each trial and combining it into a common dataset for analysis. Using the anonymized combined data we will conduct logistic regression and subgroup analyses aimed at identifying which women with previous pregnancy complications benefit most from treatment with low-molecular-weight heparin during pregnancy.
The goal of the proposed individual patient data meta-analysis is a thorough estimation of treatment effects in patients with prior individual placenta-mediated pregnancy complications and exploration of which complications are specifically prevented by low-molecular-weight heparin.
PROSPERO (International Prospective Registry of Systematic Reviews) 23 December 2013, CRD42013006249.
胎盘介导的妊娠并发症包括子痫前期、晚期妊娠丢失、胎盘早剥以及小于胎龄儿。在发达国家，它们是孕产妇、胎儿及新生儿发病和死亡的主要原因。经历过这些并发症的女性在后续妊娠中复发风险升高。然而，尽管经过数十年研究，直到最近才确定有效的预防复发策略。我们完成了一项基于汇总摘要的荟萃分析，强烈提示低分子量肝素可降低胎盘介导的复发性并发症风险。拟开展的个体患者数据荟萃分析基于此次成功合作。该项目名为AFFIRM，即低分子量肝素预防胎盘介导的妊娠并发症个体患者数据荟萃分析。
方法/设计：我们进行了一项系统评价，以识别采用低分子量肝素干预预防胎盘介导的复发性妊娠并发症的随机对照试验。代表八项试验的研究者和统计学家开会讨论个体患者数据荟萃分析的结果和分析计划。此后又增加了一项试验，共计九项符合条件的试验。在对每个试验的数据进行重新编码并合并到一个共同数据集进行分析之前，将重复原始试验的主要分析以进行质量保证。利用匿名的合并数据，我们将进行逻辑回归和亚组分析，旨在确定哪些既往有妊娠并发症的女性在孕期接受低分子量肝素治疗获益最大。
拟开展的个体患者数据荟萃分析的目标是全面评估既往有个体胎盘介导的妊娠并发症患者的治疗效果，并探索低分子量肝素具体预防了哪些并发症。
PROSPERO（国际系统评价前瞻性注册库）2013年12月23日，CRD42013006249。
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