Principal investigator: Enrique F. Schisterman, Ph.D.
The EAGeR Study is a multisite, randomized placebo-controlled clinical trial designed to evaluate the effect of daily low-dose aspirin (LDA) on live-birth rates.

Maximally fertile couples have only an approximately 30-percent chance of conception in a given menstrual cycle, and average monthly fecundity is 20 percent. Estimates of miscarriages and early pregnancy loss vary, ranging from about 15 percent to 30 percent. Available data suggest that LDA has the potential to favorably impact several aspects of reproduction, including conception, implantation, early pregnancy loss, late fetal death, low birth weight, placental insufficiency, and preterm birth. LDA is widely available, has few maternal side effects, and is inexpensive. Prior studies have focused on narrow aspects of the effects of LDA, such as in vitro fertilization outcome or the development of preeclampsia; such studies have also generally begun therapy late mid-gestation. Reproduction is unique in that each stage is inextricably linked. Therefore, better blood flow at the time of conception and implantation may ultimately lead to improved placental function and a reduced risk of preeclampsia, small-for-gestational-age infants, and preterm birth.

The EAGeR Study will recruit and follow 1,600 women as they attempt to become pregnant for up to six at-risk menstrual cycles, and then through pregnancy among those who become pregnant. The primary objective of the study is to determine the effect of LDA in combination with folic acid treatment on the incidence of live births compared to the results of folic acid alone. Secondary objectives relate to evaluation of outcomes, including the incidence of human chorionic gonadotropin (hCG)-detected pregnancy, early loss of pregnancy, and preterm delivery, among others.

For more information on the EAGeR Study, visit http://www.eagertrial.org.

DESPR Collaborators

· Mary L. Hediger, Ph.D.
· Aiyi Liu, Ph.D.
· Cuilin Zhang M.D., M.P.H., Ph.D.
· Mark Klebanoff, M.D., M.P.H.