HYDROxychloroquine in Syndrome Primary AntiPhospholipid (HYDROSAPL)
Antiphospholipid Syndrome in Pregnancy, Anticoagulants
About this trial
This is an interventional treatment trial for Antiphospholipid Syndrome in Pregnancy focused on measuring APS, Anticoagulants, Pregancy, Heparin Low-Molecular-Weight, Aspirin
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
Spontaneous consecutive pregnancy ongoing before the 14th week of gestation
-- SAPL obstetrics (modified Sapporo criteria = Sydney criteria) with fetal death ≥10 weeks of gestation without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity <34SA with placental insufficiency (with or without thrombotic SAPL)
- Signed informed consent
Exclusion Criteria:
- Other SAPL subgroups: early isolated miscarriages <10 weeks
Contraindication to hydroxychloroquine:
- retinopathy,
- hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose
- Associated systemic lupus, associated Sjogren syndrome
- Treatment with hydroxychloroquine in progress
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Lack of Social Insurance
Sites / Locations
- Hopital Saint AntoineRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Hydroxychloroquine
Placebo group
Hydroxychloroquine will be prescribed upon confirmation of pregancy at a dosage of 400 mg / day. Either in 2 doses (1 tablet of 200 mg in the morning and 1 tablet of 200 mg in the evening). Or in a single take: 2 tablets of 200 mg. Treatment will be continueted during the pregnancy and will be stopped at delivery.
Placebo will be prescribed upon confirmation of pregancy at a dosage of 400 mg / day. Either in 2 doses (1 tablet of 200 mg in the morning and 1 tablet of 200 mg in the evening). Or in a single take: 2 tablets of 200 mg. Treatment will be continueted during the pregnancy and will be stopped at delivery.