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). Recently, we found that low-dose aspirin treatment increased live birth among women with low-grade inflammation. These results suggest that low-dose aspirin may restore otherwise diminished live birth rates in women with low-grade inflammation (Sjaarda et al. Journal of Clinical Endocrinology and Metabolism 2017). We also evaluated preconception maternal lipid levels, and found that elevated total and individual lipid subtypes were associated with a longer time-to-pregnancy (Pugh et al. Human Reproduction 2017). Since lipid levels are modifiable, these results may offer a target to improve female fecundability. We also evaluated the role of subclinical hypothyroidism and antithyroid antibodies and found no associations with preterm delivery, gestational diabetes, or preeclampsia, which are reassuring findings for women with subclinical hypothyroidism (Plowden et al. American Journal of Obstetrics and Gynecology 2017). The team intends to build upon current findings from EAGeR to fill research gaps in its quest to answer public health questions for reproductive-aged women.
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