Hydroxychloroquine in Unexplained Recurrent Pregnancy Loss
Recurrent Pregnancy Loss
About this trial
This is an interventional prevention trial for Recurrent Pregnancy Loss
Eligibility 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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
No Intervention
Group A (control group)
Group B ( Hydroxychloroquine group )
Study Director
35 women in this group will receive only the standard treatment in the form of : low- dose aspirin (LDA) 81 mg/day orally (Jusprin® 81mg which manufactured by Future Pharmaceutical Company), LMWH (Enoxaparin, Clexane® which manufactured by SANOFI company) with a dose ( .5 mg/kg) subcutaneously injected/24 hr . LDA ought to be begun before origination, while LMWH ought to be begun after confirmation of pregnancy by detecting fetal viability by ultrasound till age of viability (20wks) -PLUS Placebo specially manufactured tablets in Ain shams faculty of pharmacy will start once known she is pregnan
This group included 35 women who will administered Hydroxychloroquine 200 mg (Hydroquine® 200mg which fabricated by MinaPharm Company) one tablets / day once known she is pregnant in addition to the standard therapy (LMWH + LDA )
Only those directing the study know the treatment that each participant receives Placebo OR Hydroxychloroquin