Aspirin 150 mg to Prevent Complications in Pregnant Women with Chronic Hypertension A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial

What this Trial Is About

Chronic hypertension affects 1 to 5% of women of childbearing age and can lead to serious complications during pregnancy, such as superimposed preeclampsia, placental abruption, intrauterine growth restriction, perinatal death, maternal death, or preterm delivery. This trial evaluates whether taking 150 mg of acetylsalicylic acid aspirin daily before 20 weeks of pregnancy can help prevent these complications in pregnant women with chronic hypertension. The study is a prospective randomized double-blind placebo-controlled trial conducted to provide clearer evidence on aspirins effectiveness in this specific population. Participants are randomly assigned to receive either aspirin 150 mg or a placebo once daily in the evening. The treatment starts immediately after randomization and continues until 35 weeks plus 6 days of gestation. Both the active drug and placebo are dispensed by the study centers pharmacy, and participants are given daily logs to record their treatment adherence. This design ensures careful monitoring and comparison of outcomes between the two groups. During the study, participants will undergo regular assessments of maternal and fetal health, including monitoring for preeclampsia, fetal growth, placental health, and timing of delivery. Researchers will measure a combined outcome of maternal and perinatal complications within 9 months, along with various secondary outcomes such as fetal development and child growth up to 4 years. Safety and treatment adherence are also tracked throughout. The total participation duration aligns with the pregnancy timeline, ensuring comprehensive observation of both mother and child.

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy