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Hydroxychloroquine in Prevention of Preeclampsia

NCT ID: NCT04755322

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-07-30

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.

Detailed Description

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Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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hydroxychloroquine group

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

Group Type OTHER

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine 400 mg at start of pregnancy

Folic acid

Intervention Type DRUG

5 mg

Low-dose aspirin

Intervention Type DRUG

75 mg

control group

Folic Acid 5 mg+ Low-dose aspirin 75 mg

Group Type OTHER

Folic acid

Intervention Type DRUG

5 mg

Low-dose aspirin

Intervention Type DRUG

75 mg

Interventions

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Hydroxychloroquine

Hydroxychloroquine 400 mg at start of pregnancy

Intervention Type DRUG

Folic acid

5 mg

Intervention Type DRUG

Low-dose aspirin

75 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mahmoud Mohammed

Assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abdel-rahman Mahmoud Mohammed

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HPP_2020

Identifier Type: -

Identifier Source: org_study_id