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Hydroxychloroquine and Unexplained Recurrent Miscarriage

NCT ID: NCT04228263

Last Updated: 2023-12-07

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

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-07-08

Brief Summary

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Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. 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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Unexplained Recurrent Miscarriage

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 preconceptional

Group Type OTHER

Hydroxychloroquine

Intervention Type DRUG

400mg

Folic Acid

Intervention Type DRUG

5 mg

Low-dose aspirin

Intervention Type DRUG

75 mg

control group

not receive hydroxychloroquine

Group Type OTHER

Folic Acid

Intervention Type DRUG

5 mg

Low-dose aspirin

Intervention Type DRUG

75 mg

Interventions

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Hydroxychloroquine

400mg

Intervention Type DRUG

Folic Acid

5 mg

Intervention Type DRUG

Low-dose aspirin

75 mg

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

1. Women who are already pregnant.
2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
3. Patient already using HCQ
4. Patient not get pregnant after 12 months of HCQ use.
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

Assistant 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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HRP_2020

Identifier Type: -

Identifier Source: org_study_id