Hydroxychloroquine in Prevention of Preeclampsia

Assiut University

Status: Completed

Conditions: Preeclampsia

Treatments: Drug: Hydroxychloroquine; Drug: Folic acid; Drug: Low-dose aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04755322

HPP_2020

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

hydroxychloroquine group

Other group

Description:

hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg

Treatment:

Drug: Low-dose aspirin

Drug: Hydroxychloroquine

Drug: Folic acid

control group

Other group

Description:

Folic Acid 5 mg+ Low-dose aspirin 75 mg

Treatment:

Drug: Low-dose aspirin

Drug: Folic acid