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

阿司匹林可能具有抗氧化特性，对炎症有重要作用。来自体外受精（IVF）文献的有希望的证据表明，低剂量阿司匹林可能提高生育能力，可能是由于妊娠早期灌注的改善。我们进行了一项随机试管婴儿临床试验的荟萃分析，表明妊娠早期服用阿司匹林可以降低早产和小胎龄婴儿的风险。EAGeR研究将是一项多地点、双盲随机试验，旨在评估低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，将招募1600名近期流产并计划再次怀孕的女性。每位妇女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只服用0.4毫克叶酸的安慰剂组。治疗/安慰剂的使用将在受孕前开始，并在怀孕期间继续。生育监测仪将用于帮助确定性交时间，家用数字妊娠检测试剂盒将用于确定妊娠，每日尿液样本将被收集以监测早期妊娠和妊娠丢失。妊娠期间将监测流产、妊娠并发症和围产期结局。我们假设低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。增加氧气和营养的供应应促进胎盘和胎儿生长，提高受孕率，减少妊娠损失和妊娠并发症，从而改善围产期结局。这项试验的发现不仅对试图怀孕的妇女有重要意义，而且对想要保持健康妊娠并获得最佳围产期结果的妇女也有重要意义。我们将在某些子研究中利用我们开发的与池相关的方法，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.