Evaluation of the benefit of using hydroxychloroquine for uncomplicated term pregnancy in patients with primary obstetric antiphospholipid syndrome

Phase 1

• Conditions: Primary obstetrical antiphospholipid syndrome; MedDRA version: 20.0Level: PTClassification code 10002817Term: Antiphospholipid syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004866-86-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-03
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified