Primary obstetrical antiphospholipid syndrome MedDRA version: 20.0 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: Sulfate d'hydroxychloroquine
Other descriptive name: Sulfate d'hydroxychloroquine
Concentration un
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit of adding or not adding hydroxychloroquine to the usual medical management in case of obstetrical SAPL in obtaining an uncomplicated pregnancy over time with a eutrophic child: (1) living child; (2) without maternal complication (pre-eclampsia, HELLP, thrombosis); (3) without fetal complications (IUGR); (4) without complications or neonatal morbidity on day 7 (hypotrophy, infectious, prematurity); (5) term> 37 WA.;Secondary Objective: - Evaluation of the efficacy of a hydroxychloroquine treatment during pregnancy on the percentage of maternal or fetal complications (prematurity, preeclampsia, IUGR, HELPP syndrome, retroplacental hematoma, thrombosis) - Evaluation of the efficacy of hydroxychloroquine treatment on neonatal characteristics (weight and / or height and / or PC <5th and 10th percentile, APGAR 5 minutes = 7) - To study the influence of the blood concentration of hydroxychloroquine on the risk of maternal, fetal complications during pregnancy - To study the influence of hydroxychloroquine treatment on the evolution of complement levels during pregnancy - To study the tolerance of hydroxychloroquine treatment during pregnancy. - To study the influence of a hydroxychloroquine treatment on the modification of the immune populations T, B, NK and cytokines. - Study compliance with hydroxychloroquine treatment during pregnancy;Primary end point(s): Percentage of uncomplicated term pregnancies with a eutrophic child (= a live birth with no maternal, fetal or neonatal complications);Timepoint(s) of evaluation of this end point: At delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of complications (prematurity, preeclampsia, IUGR, HELPP syndrome, thrombosis, retroplacental hematoma) during pregnancy - Neonatal characteristics (weight and / or height and / or PC <10percentile, APGAR 1/5 minutes <or equal 7) - Percentage of SAPL complications according to the rate of hydroxychloroquine - Evolution of the level of antiphospholipid antibodies - Evolution of the complement level during pregnancy - Percentage of maternal, fetal and neonatal side effects related to hydroxychloroquine - Modification of the frequencies of the immune populations T, B, NK and cytokine levels under hydroxychloroquine (ancillary study) - Number of hydroxychloroquine tablets taken (Patient Log);Timepoint(s) of evaluation of this end point: During pregnency and at delivery | — |
Countries
France
Contacts
Public ContactElodie SOLER -DRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed