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

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

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Abstract

The EAGeR Study is a multi-site, prospective, double-blind, block-randomized trial designed to assess the effects of low-dose aspirin on implantation and pregnancy outcomes. In this trial, 1,228 regularly menstruating women aged 18-40 years with a history of one or two miscarriages and attempting pregnancy again were block-randomized to receive either daily low dose aspirin (81mg) or placebo. Treatment or placebo began before conception and continued for 6 months of trying or through week 36 of pregnancy among women who became pregnant. Participants were stratified into two groups: 1) original: women with one documented pregnancy loss at <20 weeks gestation during the past 12 months; and 2) expanded: women with 1-2 prior pregnancy losses, regardless of gestational age of the loss or time since the loss. Women used fertility monitors to time intercourse and used home pregnancy tests to detect pregnancy. Primary outcomes of the EAGeR trial were published in 2014 (Schisterman et al. Lancet 2014), with additional secondary outcomes published in 2015-2017. Overall, daily low-dose aspirin was not found to prevent subsequent pregnancy loss among women with a history of 1-2 prior losses (Schisterman et al. Lancet 2014; Mumford et al. Human Reproduction 2016). More recently, the EAGeR team continued the story of discovery from the EAGeR cohort identifying that low grade inflammation was associated with fewer spontaneous conceptions, which was ameliorated by treatment with daily low dose aspirin. The team extended prior work on the effects of preconception initiated low-dose aspirin therapy finding that low-dose aspirin was not associated with mode of delivery (PMID: 33075844) or menstrual cycle characteristics (PMCID: PMC7722096). Further, per-protocol effects of treatment were estimated accounting for nonadherence which suggested that preconception use of low dose aspirin at least 4 days per week may improve reproductive outcomes (PMID: 33493011). The team also identified that exposure to opioids (PMCID: PMC7725439; PMID: 33001215), cannabis (PMID: 33421071), and selective serotonin reuptake inhibitors (PMCID: PMC8094179) was associated with reduced fecundability.