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Low-dose aspirin increases live birth rate in women with low-grade inflammation, pregnancy loss
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In healthy women trying to conceive who have experienced pregnancy loss, treatment with daily, low-dose aspirin was associated with an increase in both pregnancy and live birth rates among those who had higher levels of high-sensitivity C-reactive protein vs. those assigned a placebo, according to findings from a randomized controlled trial.
“These findings elucidate two concepts for the first time: Systemic, chronic, low-grade inflammation may significantly harm women’s ability to become pregnant and her inflammation changes through pregnancy, and this detriment may be restored to expected levels using preconception-initiated [low-dose aspirin] therapy,” Lindsey A. Sjaarda, PhD, of the division of intramural population health research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Maryland, and colleagues wrote. “Specifically, among women with relatively elevated baseline [high-sensitivity C-reactive protein] having a history of pregnancy loss, [low-dose aspirin] restored clinically confirmed pregnancy and live birth rates and lowered [high-sensitivity C-reactive protein] throughout pregnancy.”
Sjaarda and colleagues analyzed data from 1,228 healthy women aged 40 years or younger with one or two prior pregnancy losses participating in the EAGER trial, a randomized, double blind, placebo-controlled trial across four medical centers in the United States from 2007 to 2012 (95% white). Eligible women were actively attempting to conceive and had regular menstrual cycles and no known history of infertility before enrollment. Researchers assigned women to daily, low-dose aspirin (81 mg plus 400 µg folic acid; n = 615) or matching placebo plus folic acid (n = 613); women were stratified by tertile of preconception high-sensitivity C-reactive protein (low, < 0.7 mg/L; mid-level, 0.7-1.95 mg/L; high, ≥ 1.95 mg/L), measured at baseline and again at 8, 20 and 36 weeks’ gestation for those who became pregnant. Women were instructed to take study pills until completion of six menstrual cycles of follow-up while attempting pregnancy or until 36 weeks’ gestation. Primary outcomes were clinically confirmed pregnancy and live birth; pregnancy losses were examined as a secondary outcome.
Within the cohort, 67% became pregnant; 55% of women had a live birth.
Researchers found that, for women in the highest high-sensitivity C-reactive protein tertile, low-dose aspirin therapy was associated with a 31% increase in clinically confirmed pregnancy vs. women in the highest tertile assigned placebo (pregnancy rate, 71% vs. 54%). Researchers also observed a 35% increase in the live birth rate for women assigned low-dose aspirin in the high-sensitivity C-reactive protein group vs. those assigned placebo (59% vs. 44%).
There were no between-group differences for live births observed in women either assigned low-dose aspirin or placebo in the low and mid-level high-sensitivity C-reactive protein groups, according to researchers.
Overall, the number needed to treat within the highest high-sensitivity C-reactive protein tertile was seven women for every additional live birth observed, the researchers noted; however, the effect of low-dose aspirin among all women was not significant. There was no observable effect of low-dose aspirin on pregnancy loss. – by Regina Schaffer
Disclosure: The researchers report no relevant financial disclosures.
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