Study to Look at Aspirin as Aid to Conception, Healthy Pregnancy

BUFFALO, N.Y. -- Researchers at the University at Buffalo and the University of Utah are beginning a clinical trial to test whether aspirin can improve a woman's chances of becoming pregnant and of maintaining a pregnancy to term.

UB's portion of the study is funded by a $2.8 million contract with the National Institute of Child Health and Development.

The trial is aimed at women who have miscarried a pregnancy in the past year.

"In women who have had their first miscarriage, the reasons for losing that pregnancy are in many instances unknown," said Jean Wactawski-Wende, Ph.D., UB associate professor of social and preventive medicine and principal investigator of the UB clinical center.

"These women generally are advised to try to get pregnant again, but health-care providers can offer limited assistance on any specific actions to take to improve their next pregnancy outcome," she noted. "If aspirin can help some women become pregnant or maintain a health pregnancy, it will be a critically important finding.

"Aspirin is available, inexpensive and has very few side effects," she added. "We're hopeful that this trial could produce an important finding."

Statistics show that in the United States, 10-15 percent of couples trying to become pregnant are not able to conceive, 15-31 percent of pregnancies that do occur end in miscarriage, and 8-15 percent of pregnancies that continue beyond 20 weeks end in premature birth, putting these infants at risk for increased health problems.

Aspirin has been shown to have beneficial effects in humans, said Wactawski-Wende. "It is an anticoagulant and an anti-inflammatory agent. It may aid in implantation of the egg in the uterine wall, and has potential for producing a positive effect on blood flow to the placenta. It may aid in reducing preeclampsia. This clinical trial provides an opportunity to determine the impact of low-dose aspirin on many pregnancy outcomes."

The Effects of Aspirin in Gestation & Reproduction trial, or EAGeR, will begin this spring and will continue for five years. The UB center will enroll 535 women. Another 1,070 will be recruited by investigators at the University of Utah, for a total enrollment of 1,600 women.

Participants must be between the ages of 18 and 40, have had one miscarriage in the year prior to entering the study, wish to become pregnant and are not already pregnant when they start the study. All will take 400 micrograms of folic acid (a B vitamin shown to reduce the chance of certain birth defects if started early) plus either an 80 milligram aspirin pill or a placebo pill daily.

The women will come to the UB study clinic twice a month for two months and will be followed for an additional four months in the clinic or by telephone. If they become pregnant they will be followed throughout the pregnancy. Participants will take their study pills daily, maintain daily records and provide both urine and blood samples.

Recruitment will begin shortly. "We are thrilled to be able to conduct this trial in Western New York and offer women in our community the opportunity to take part in this important study," said Wactawski-Wende.

UB consultants include Richard Brown, Ph.D., Maurizio Trevisan, M.D., Moeen Abu-Sitta, M.D., John Yeh, M.D., Dennis Weppner, M.D., Lawrence Gugino, M.D., Ken Crickard, M.D., and Michael Sullivan, M.D.

The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York. The School of Public Health and Health Professions is one of five schools that constitute UB's Academic Health Center.