Hydroxychloroquine and Unexplained Recurrent Miscarriage

Assiut University

Status: Completed

Conditions: Unexplained Recurrent Miscarriage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04228263

HRP_2020

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria

2. Women who are already pregnant.

3. 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 .

4. Patient already using HCQ

5. Patient not get pregnant after 12 months of HCQ use.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

hydroxychloroquine group

Other group

Description:

hydroxychloroquine 400 mg preconceptional

Treatment:

Drug: Folic Acid

Drug: Hydroxychloroquine

Drug: Low-dose aspirin

control group

Other group

Description:

not receive hydroxychloroquine

Treatment:

Drug: Folic Acid

Drug: Low-dose aspirin