Clinical trial

Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia

Name
HPP_2020
Description
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.
Trial arms
Trial start
2021-03-01
Estimated PCD
2023-07-30
Trial end
2023-07-30
Status
Completed
Treatment
Hydroxychloroquine
Hydroxychloroquine 400 mg at start of pregnancy
Arms:
hydroxychloroquine group
Folic acid
5 mg
Arms:
control group, hydroxychloroquine group
Low-dose aspirin
75 mg
Arms:
control group, hydroxychloroquine group
Size
50
Primary endpoint
number of cases of preeclampsia
9 month
Eligibility criteria
Inclusion Criteria: 1. Pregnant women in 1st 6 weeks gestation. 2. History of preeclampsia in previous pregnancies. 3. Women who accepted to participate Exclusion Criteria: 1. Risk factors (multiple gestation, chronic hypertension, chronic renal disease). 2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism 3. Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-12-08

1 organization

3 products

1 indication

Organization
Assiut University
Indication
Preeclampsia
Product
Folic acid
Product
Aspirin