Hydroxychloroquine in Unexplained Recurrent Pregnancy Loss

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate efficacy and safety of Hydroxychloroquin in improving pregnancy outcome in women with unexplained recurrent pregnancy loss .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Aspirin; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Women aged between 18 and 35 years inclusive.

• Women with at least three previous consecutive miscarriages in the first trimester of pregnancy of unknown origin with no uterine cavity abnormality that might explain recurrent miscarriage at 3D ultrasonography

• Women who have given their informed consent.

• Patient who did received standard treatment and failed in an ongoing pregnancy

Exclusion Criteria:

• Previous history VTE (venous thromboembolization)

• Persistent positive APL antibodies: lupus anticoagulant and/or APL (anticardiolipin or anticardiolipin IgG or IgM) titers >99th percentile or >40 with at least 12 weeks interval between two positive determinations (persistent antibodies) or a specific clinical setting of APS (thrombotic or obstetrical, apart from RM in the first trimester of pregnancy) .

• 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 or haematologic disease) .

• Indication to a treatment by HCQ (rheumatoid arthritis, Lupus, solar eczema) or previous exposure for >5years to HCQ.

• BMI > 35

• Condition may have an effect on immune reaction e.g. history of HCV or HBV .

• Endocrinopathies such as ( DM ,thyroid disorders , hyperprolactinemia ) .

• History of hormonal contraception or intrauterine device usage in last 3 months preceeding .