The Efficacy of Aspirin Combined With Hydroxychloroquine in High Risk Pregnancies for Preeclampsia A Multicenter Open-label Trial

What this Trial Is About

Researchers are evaluating the effects of combining aspirin with hydroxychloroquine in pregnant women who are at high risk for preeclampsia. This prospective, open-label, multicenter trial focuses on women with a singleton pregnancy who previously experienced adverse outcomes such as preeclampsia, fetal growth restriction, or intrauterine fetal death. The study is designed as a Phase 3 trial to understand the safety and effectiveness of this treatment combination during pregnancy. Participants are randomly assigned to receive either hydroxychloroquine 200 mg combined with aspirin 100 mg daily or aspirin 100 mg alone. Treatment starts between 12 and 22 weeks of pregnancy and continues until 36 weeks of gestation. Medication adherence is closely monitored and expected to be above 80% throughout the treatment period. During the study, participants will undergo regular assessments to monitor health and safety, including evaluations related to the composite morbidity during the gestational period. Researchers will follow participants until the end of pregnancy to measure outcomes related to preeclampsia and other complications. The study involves continuous monitoring to ensure participant safety and treatment adherence throughout the trial.

The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia