drugset / Trial / NCT04755322

Hydroxychloroquine in Prevention of Preeclampsia

NCT04755322

Completed 50 enrolled Assiut University
RandomizedParallel-groupOpen-labelPrevention

Summary

Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.

Timeline

Start
2021-03-01
Primary completion
2023-07-30
Completion
2023-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 400 mg
Background Aspirin Small molecule 75 mg
Background folic acid Other / unclassified 5 mg

Indications