EAGeR Trial - The Effects of Aspirin in Gestation and Reproduction Trial

阿司匹林可能具有抗氧化特性，并在炎症中发挥重要作用。来自体外受精(IVF)文献的有希望的证据表明，小剂量的阿司匹林可能会改善生育能力，可能是由于改善了怀孕早期的血流灌注。我们对随机试管受精临床试验进行了荟萃分析，这些试验表明，在怀孕早期服用阿司匹林可能会降低早产和小于胎龄儿的风险。这项急切的研究将是一项多点、双盲的随机试验，旨在评估小剂量阿司匹林对植入和妊娠结局的影响。这将是迄今为止规模最大的此类研究，招募了1600名最近经历过妊娠丢失并计划再次怀孕的女性。每位女性将被随机分配到每天服用81毫克阿司匹林加0.4毫克叶酸的治疗组或仅服用0.4毫克叶酸的安慰剂组。治疗/安慰剂管理将在受孕前开始，并在怀孕期间继续。生育监测器将被用来辅助性交的时间，家庭数字怀孕测试工具将被用来确定怀孕，每天的尿样将被收集来监测非常早期的怀孕和妊娠丢失。将在整个怀孕期间监测妊娠丢失、妊娠并发症和围产儿结局。我们推测，小剂量阿司匹林可以减少氧化应激和炎症，从而降低血管阻力，改善血流和胎盘灌注量。增加氧气和营养物质的供应应该会促进胎盘和胎儿的生长，提高受孕率，减少妊娠丢失和妊娠并发症，从而改善围产儿结局。这项试验的结果不仅对试图怀孕的妇女有重要影响，而且对希望保持健康怀孕和实现最佳围产期结果的妇女也有重要影响。我们将在某些子研究中使用我们开发的与汇集相关的方法，例如对指定治疗依从性的研究。

Aspirin might have antioxidant properties and plays an important role in inflammation. Promising evidence from the in vitro fertilization (IVF) literature suggests that low-dose aspirin may improve fecundity, possibly due to improved perfusion early in pregnancy. We conducted a meta-analysis of randomized IVF clinical trials that suggested that aspirin during early gestation may reduce the risk of preterm birth and small-for-gestational-age babies. The EAGeR study will be a multi-site, double-blinded randomized trial designed to assess the effects of low-dose aspirin on implantation and pregnancy outcome. It will be the largest such study to-date, enrolling 1,600 women experiencing a recent pregnancy loss who are planning subsequent pregnancies. Each woman will be randomly assigned to the treatment group with 81 mg aspirin plus 0.4 mg folic acid daily or the placebo group with 0.4 mg folic acid only. Treatment/placebo administration will start prior to conception and continue during pregnancy. Fertility monitors will be used to assist with timing of intercourse, home digital pregnancy testing kits will be used to determine pregnancy, and daily urine samples will be collected to monitor very early pregnancy and pregnancy loss. Pregnancy loss, pregnancy complications and perinatal outcomes will be monitored throughout pregnancy. We hypothesize that low-dose aspirin may reduce oxidative stress and inflammation and, therefore, reduce vascular resistance and improve blood flow and placental perfusion. An increased supply of oxygen and nutrients should promote placental and fetal growth, enhance conception rates, reduce pregnancy loss and pregnancy complications and, thereby, improve perinatal outcomes. Findings from this trial will have important implications not only for women trying to conceive but also for women who want to maintain a healthy pregnancy and achieve optimal perinatal outcomes. We will utilize the methods we have developed related to pooling in certain sub-studies, such as the study of compliance with assigned treatment.