Hydroxychloroquine in Prevention of Preeclampsia

Not Applicable

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Hydroxychloroquine; Drug: Folic acid; Drug: Low-dose aspirin

• Registration Number: NCT04755322
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Study Start: 2021-03-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Pregnant women in 1st 6 weeks gestation.
2. History of preeclampsia in previous pregnancies.
3. Women who accepted to participate

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydroxychloroquine group	Hydroxychloroquine	hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg
hydroxychloroquine group	Folic acid	hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg
hydroxychloroquine group	Low-dose aspirin	hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg
control group	Folic acid	Folic Acid 5 mg+ Low-dose aspirin 75 mg
control group	Low-dose aspirin	Folic Acid 5 mg+ Low-dose aspirin 75 mg

Primary Outcome Measures

Name	Time	Method
number of cases of preeclampsia	9 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Abdel-rahman Mahmoud Mohammed; 🇪🇬 Assiut, Egypt