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.

Project Start
Project End
Budget Start
Budget End
Support Year
7
Fiscal Year
2013
Total Cost
$430,993
Indirect Cost
City
State
Country
Zip Code
Ahrens, Katherine A; Silver, Robert M; Mumford, Sunni L et al. (2016) Complications and Safety of Preconception Low-Dose Aspirin Among Women With Prior Pregnancy Losses. Obstet Gynecol 127:689-98
Zarek, Shvetha M; Mitchell, Emily M; Sjaarda, Lindsey A et al. (2016) Antimüllerian hormone and pregnancy loss from the Effects of Aspirin in Gestation and Reproduction trial. Fertil Steril 105:946-952.e2
Wong, Luchin F; Schliep, Karen C; Silver, Robert M et al. (2015) The effect of a very short interpregnancy interval and pregnancy outcomes following a previous pregnancy loss. Am J Obstet Gynecol 212:375.e1-11
Radin, Rose G; Mumford, Sunni L; Silver, Robert M et al. (2015) Sex ratio following preconception low-dose aspirin in women with prior pregnancy loss. J Clin Invest 125:3619-26
Lesher, Laurie L; Matyas, Rebecca A; Sjaarda, Lindsey A et al. (2015) Recruitment for longitudinal, randomised pregnancy trials initiated preconception: lessons from the effects of aspirin in gestation and reproduction trial. Paediatr Perinat Epidemiol 29:162-7
Schisterman, Enrique F; Mumford, Sunni L; Schliep, Karen C et al. (2015) Preconception low dose aspirin and time to pregnancy: findings from the effects of aspirin in gestation and reproduction randomized trial. J Clin Endocrinol Metab 100:1785-91
Silver, Robert M; Ahrens, Katherine; Wong, Luchin F et al. (2015) Low-dose aspirin and preterm birth: a randomized controlled trial. Obstet Gynecol 125:876-84
Romero, S T; Geiersbach, K B; Paxton, C N et al. (2015) Differentiation of genetic abnormalities in early pregnancy loss. Ultrasound Obstet Gynecol 45:89-94
Schisterman, Enrique F; Silver, Robert M; Lesher, Laurie L et al. (2014) Preconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial. Lancet 384:29-36
Schisterman, Enrique F; Silver, Robert M; Perkins, Neil J et al. (2013) A randomised trial to evaluate the effects of low-dose aspirin in gestation and reproduction: design and baseline characteristics. Paediatr Perinat Epidemiol 27:598-609

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