Hydroxychloroquine in Prevention of Preeclampsia

Study Overview
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Brief Summary
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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.

Official Title
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Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Folic acid
* Drug: Low-dose aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in 1st 6 weeks gestation. History of preeclampsia in previous pregnancies. Women who accepted to participate Exclusion Criteria: Risk factors (multiple gestation, chronic hypertension, chronic renal disease). 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 Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hydroxychloroquine group<br>hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg | Drug: Hydroxychloroquine<br>* Hydroxychloroquine 400 mg at start of pregnancy<br>Drug: Folic acid<br>* 5 mg<br>Drug: Low-dose aspirin<br>* 75 mg<br>|
| Other: control group<br>Folic Acid 5 mg+ Low-dose aspirin 75 mg | Drug: Folic acid<br>* 5 mg<br>Drug: Low-dose aspirin<br>* 75 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cases of preeclampsia |  | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema |  | 9 month | 
| Number of pregnancies with fetal malformation |  | 9 months | 
| number of live birth |  | 9 months |