Evaluation of the benefit of adjuvant treatment with hydroxychloroquine to usual medical care for uncomplicated term pregnancy in patients with primary obstetrical antiphospholipid syndrome: randomized, double-blind, placebo-controlled phase II study. HYDROSAPL study - HYDROSAP

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 110 人开始时间: 2020年12月3日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•- Woman aged = to 18 years
•- Obstetric SAPL (modified Sapporo criteria = Sydney criteria) defined as fetal death =10 weeks of amenorrhea without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity <34SA related to placental insufficiency with or without thrombotic SAPL
•- Spontaneous pregnancy in progress before 14 SA
•- Ability to give informed, written, dated and signed consent prior to the commencement of any trial-related procedure and to comply with protocol recommendations
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Other SAPL subgroups: early isolated miscarriage <10 SA
•- Minor patient
•- Not affiliated to a social security scheme
•- Contraindication to hydroxychloroquine
•o retinopathies,
•o hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication, including lactose
•- Systemic systemic lupus, associated Sjogren syndrome
•- Hydroxychloroquine treatment in progress
•- Patient under guardianship or curatorship
•- Patient deprived of liberty

发起方