A research team at The Ohio State University Wexner Medical Center and College of Medicine has been approved for a $14 million award from the Patient-Centered Outcomes Research Institute (PCORI) to study whether a higher daily dose of aspirin is more effective in decreasing the risk of dangerous blood pressure complications among some pregnant people.
During pregnancy, people are at risk of developing preeclampsia and gestational hypertension. Both disorders are characterized by high blood pressure and bring with them the potential for injury to the brain, lungs, kidneys and liver. These hypertensive disorders impact nearly one in seven pregnant individuals, are increasing by about 10% every year, and disproportionately affect minoritized communities and other groups with historical disadvantage.
Currently, delivering the baby is the only treatment for these conditions, which often means babies are born too early and have increased risks for complications such as bleeding in the brain and infections. Given the high frequency, related complications, and inequities, it is important to improve treatment methods."
Maged Costantine, MD, study's principal investigator, division director of maternal fetal medicine at Ohio State Wexner Medical Center and professor of obstetrics and gynecology
Many professional societies, such as the Society for Maternal-Fetal Medicine, say that pregnant people at higher risk of these hypertensive disorders should take low-dose aspirin every day to prevent these blood pressure complications.
"While 81mg is most often used, a higher dose may work better for patients, although that possibility has not been evaluated adequately", said co-principal investigator Kara Rood, MD, maternal fetal medicine physician and associate professor at Ohio State. "It is also important to identify whether aspirin works equally well for everyone, for example those with diabetes versus those with chronic hypertension, and to understand any barriers to adhering to recommended low-dose aspirin therapy."
The study also will be led by co-principal investigator Denise Scholtens, professor and division chief of biostatistics in preventive medicine at Northwestern University Feinberg School of Medicine and director of Northwestern's Data Analysis and Coordinating Center.
Other key study investigators at Ohio State include William Grobman, MD, maternal fetal medicine physician and professor of obstetrics and gynecology; Ann Scheck McAlearney, ScD, professor of family medicine, associate dean for health sciences research and director of CATALYST; Anne Trinh, MPH, director of programs and strategic initiatives at the Center for HOPES; and Melanie Paglione, RN, the consortium's lead research nurse coordinator. At Northwestern, Kiarri Kerhaw, PhD, associate professor and social epidemiologist, will assist in approach and data interpretation as well.
The research team aims to enroll more than 10,000 pregnant people at higher risk for hypertensive disorders in pregnancy at 11 clinical centers across the U.S. Participants will be randomized to two groups; one will take 81mg aspirin daily and the other will take 162mg daily. They will be followed until six weeks after delivery. Researchers will compare the two groups according to the frequency of developing hypertensive disorders, their overall health and birth experience, and whether they have a baby who is born too small or too early, receives special care after delivery, has issues with bonding, or does not survive.
"This study will help answer an important question that will improve the health of all pregnant people and their babies and may also reduce health disparities," said Costantine. "When completed, this will be the largest and most up-to-date study focused on the ideal dose of aspirin to prevent blood pressure problems in pregnancy."
"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders, but also for its conduct in real-world settings," said Nakela L. Cook, MD, MPH, PCORI executive director. "It has the potential to answer an important question about prevention of hypertensive disorders of pregnancy and fill a crucial evidence gap. We look forward to following the study's progress and working with the Ohio State University to share its results."
Many clinical studies test whether an approach to care works under carefully controlled conditions in specialized research centers, but health care is rarely delivered in such optimized settings. Pragmatic clinical studies test a treatment's effectiveness in "real-world" practice situations, such as typical hospitals and outpatient clinics, and also can include a wider range of study participants, making their findings more generally applicable.
Ohio State's funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
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