Hydroxychloroquine and Unexplained Recurrent Miscarriage

Study Overview
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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.

Official Title
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Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage

Conditions
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Unexplained Recurrent Miscarriage

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 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 Women who are already pregnant. 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 . Patient already using HCQ Patient not get pregnant after 12 months of HCQ use.

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 preconceptional | Drug: Hydroxychloroquine<br>* 400mg<br>Drug: Folic Acid<br>* 5 mg<br>Drug: Low-dose aspirin<br>* 75 mg<br>|
| Other: control group<br>not receive hydroxychloroquine | 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 viable fetuses at 20 weeks gestation |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with miscarriage before 20 weeks |  | 5 months | 
| Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation) |  | 9 months | 
| Number of fetus with Major congenital anmalies |  | 9 months | 
| Number of Live birth |  | 9 months | 
| Number of Preterm delivery before 37 week gestation. |  | 8 months |