RESEARCH TRIANGLE PARK, N.C. — A study published today in The Lancet found that administering a low-dose aspirin regimen for pregnant women in low- and middle-income countries (LMIC) can reduce pre-term delivery by 11%.  The study was led by Matthew K. Hoffman of Christina Care in Newark, Delaware, with RTI International, a non-profit research institute, and colleagues in the Global Network for Women’s and Children’s Health Research, a clinical trials network funded by NIH’s Eunice Kennedy Shriver National institute of Child Health and Human Development (NICHD).

Pre-term delivery – childbirth before 37 weeks – is the most common cause of infant mortality; often occurring in regions without dedicated pre-natal care. The study, which spanned across seven sites throughout six countries, evaluated nearly 12,000 first-time mothers. Women, ages 18-40, at each of the sites were randomly assigned low-dose aspirin (81 mg) or placebo tablets during their first trimester up to 36 weeks gestation.

“The data from the study reinforces our hypothesis that introducing a low-dose aspirin regimen to first-time mothers is not only safe, but effective in reducing pre-term deliveries,” said Matt Hoffman, M.D., MPH, FACOG, Director of the Center for Women’s and Children’s Health at Christina Care.  “The work opens new research pathways to consider in preventing pre-term birth and could lead to large reductions in infant mortality, globally.”

Women in LMIC populations were selected because they are more unlikely to actively prevent premature birth yet have a higher tendency to deliver pre-term – this can be due to lack of obstetrical history or lack of regular pre-natal care. Participants were chosen at random using an algorithm developed by RTI. All participants of the study were unaware which group of women received the low-dose aspirin or placebo.

“It's still unclear how this regimen can be applied to pregnant women who have previously had a successful birth(s), but we hope that this research is a step in the right direction of reducing pre-birth rates for women from all backgrounds,” said Elizabeth McClure, Principal Investigator of the Data Coordinating Center at RTI. “We plan to work with the World Health Organization (WHO) and other international organizations for next steps on incorporating our results into international policy.”

Although the primary goal of the research was to show a reduction in pre-term deliveries across populations of first-time mothers, several secondary outcomes were also evaluated by researchers. Some of the secondary outcomes show that low-dose aspirin regimens in these populations can also lead to reductions in perinatal mortality, fetal loss, early preterm delivery, and early preterm hypertensive disorders. The authors also noted that the low cost of low-dose aspirin therapy show that it could easily and safely be implemented for widescale use.

The Global Network ASPIRIN Working Group will continue to work on secondary analyses based on the research gathered to further study low-dose aspirin for improved delivery options. The study was held across seven sites in India, Pakistan, Zambia, the Democratic Republic of the Congo, Guatemala and Kenya from 2016-2018. Funding was provided by NICHD. For more information, please visit: The Lancet.