Comparing Two Aspirin Doses to Prevent High Blood Pressure Disorders in Pregnancy A Study of 81 mg vs 162 mg Aspirin Daily in Pregnant Individuals at Risk

What this Trial Is About

Researchers are studying the prevention of hypertensive disorders of pregnancy HDP, such as preeclampsia and gestational hypertension, which affect about 15% of pregnant individuals and disproportionately impact certain populations. The study aims to compare the effectiveness of two aspirin doses, 162 mgday versus 81 mgday, in preventing these conditions. It also seeks to understand factors influencing adherence to aspirin therapy to improve its implementation and benefits at the population level. Participants will be randomly assigned to take either 81 mg or 162 mg of aspirin daily during pregnancy. The study is designed as a large, pragmatic, comparative effectiveness trial with a quadruple masking approach to maintain objectivity. Researchers will monitor outcomes related to hypertensive disorders, maternal and neonatal health, and safety, as well as patient-reported experiences. The study will follow participants from early pregnancy through delivery and postpartum periods. During the trial, participants will be closely monitored for the development of hypertensive disorders from more than 20 weeks of gestation until hospital discharge after delivery, with follow-up extending up to six weeks postpartum. Researchers will collect data on preterm birth, maternal and neonatal complications, and adherence to aspirin therapy. Patient questionnaires on maternal health and bonding with the infant will also be included. The trial is sponsored by Ohio State University and is expected to continue until 2030, with participants involved from early pregnancy through the postpartum period.

Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL