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Pregnancy Loss – EAGeR Low-Dose Aspirin Study Recruiting Participants

Women thinking about becoming pregnant again after suffering an intra-uterine loss could find hope in an ordinary medicine cabinet item: a low-dose aspirin (LDA) tablet.

That’s the hypothesis of the Effects of Aspirin in Gestation & Reproduction (EAGeR) study, which is conducted by the National Institute of Child Health and Human Development and includes the Department of Obstetrics and Gynecology at University of Colorado Denver (UCD) School of Medicine as well as three other academic institutions.

The secret to a
successful pregnancy?

The study is currently recruiting women between the ages and 18 and 40 who have had one or two pregnancy losses but are interested in trying to conceive again.

Promising Findings

Researchers want to find out if LDA (81 milligrams), which has been shown to improve blood flow and decrease the clotting action of platelets, can improve utero-placental blood flow and thus increase the chances of conception, notes assistant professor of Obstetrics and Gynecology (Ob/Gyn) Anne Lynch, MD, MSPH, the principal investigator at UCD.

Previous trials showed that LDA decreased the risk of preeclampsia, or pregnancy-induced hypertension, in women at increased risk for the disorder. LDA has also been used to treat antiphospholipid symdrome, a condition that causes blood clots and increases the risk of preeclampsia, preterm delivery and pregnancy loss.

UCD Selected to Join the Study

The study, which began in 2007 and is scheduled to run for five years, hopes to recruit 1,600 patients, says Lynch. UCD joined the study two months ago after it successfully bid to subcontract with the University of Utah Department of Obstetrics and Gynecology, also a site for the study.

Anne Lynch, MD, believes that UCD could recruit as many
as 100 volunteers for the EAGeR study.

The study provides a broad range of services to those it enrolls, Lynch says. After a screening process, half the women invited will take LDA, while the other half will get a placebo.

All participants receive a baseline medical history, a fertility monitor, pregnancy tests, folic acid supplements, supplies for collecting and freezing urine samples, an ultrasound if they become pregnant, counseling from a UCH nurse and payment for their participation. The study will also collect blood and urine samples from all participants and tissue samples from women who suffer a pregnancy loss.

“We’ll follow each participant actively until they become pregnant,” Lynch says. “They will then return to their own health care provider for prenatal care and deliver at the hospital of their choice while still receiving regular follow-up from the Denver EAGeR team.”

Researchers Foresee Valuable Data

The study presents researchers with a valuable opportunity to learn more about pregnancy, Lynch emphasizes. “It will provide a huge amount of data,” she notes, “that can help us understand the events around the time of conception and pregnancy loss.”

Lynch anticipates the study will have all the data together by 2011, when researchers will analyze it to look for answers and trends.

For more details on the EAGeR study, visit http://www.eagertrial.org/index.php.

 


This page is adapted from a story that appeared in the UCH Insider, the hospital's candid e-newsletter. The Insider, which is published biweekly, is available to people outside the hospital via a free e-mail subscription. Tyler Smith (tyler.smith@uch.edu) is managing editor of the Insider.