Pregnant women with antiphospholipid antibodies MedDRA version: 21.1 Level: PT Classification code 10048678 Term: Antiphospholipid antibodies positive System Organ Class: 10022891 - Investigations
Conditions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women with known aPL (ie. isolated aPL or APS) who are planning pregnancy. aPL are defined by the presence of a positive test for anticardiolipin antibodies (IgG/IgM isotypes > 95th percentile) and/or lupus anticoagulant and/or anti- beta 2 glycoprotein-I (IgG/IgM isotypes > 95th percentile), on two or more consecutive occasions more than 12 weeks apart (a positive aPL test is defined under ‘glossary and definitions’). The last positive test must be within 12 months of study entry. 2. Written informed consent to participate 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 328 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are already pregnant 2. Allergy or adverse event to hydroxychloroquine. Hypersensitivity to the active substance, 4-aminoquinoline or any of the compounds of the IMP or placebo. 3. Current treatment with hydroxychloroquine 4. Age 45 5. Body weight < 45 kg 6. Psoriasis 7. Uncontrolled epilepsy 8. Anti-Ro antibodies 9. Renal replacement therapy 10. Other severe active co-morbidities (HIV, hepatitis B, severe gastrointestinal, neurological or blood disorders) 11. Porphyria 12. History of retinopathy or newly diagnosed retinopathy 13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption 14. History of glucose-6-dehydrogenase deficiency 15. Participation in any other IMP trial at the time of consent 16. Previous pregnancy failure on hydroxychloroquine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of HCQ on pregnancy outcome in women with antiphospholipid antibodies. ;Secondary Objective: Only for women recruited at St Thomas’ Hospital: To collect blood samples in order to study the compliance and the pharmacokinetics of HCQ in pregnant women with aPL (the analysis will be funded separately). ;Primary end point(s): The primary endpoint is a composite of three principal aPL-related adverse pregnancy outcomes: one or more pregnancy loss(es) (either < 10 weeks gestation or beyond 10 weeks of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus) and premature birth of a morphologically normal neonate before 34 weeks due to any of: pre-eclampsia, eclampsia, recognised features of placental insufficiency Premature birth for other reasons will not be included. The components of the primary endpoint will each be presented as secondary endpoints. ;Timepoint(s) of evaluation of this end point: The primary endpoint is a composite outcome of complications during pregnancy and post partum. Therefore, timepoints of evaluation for the primary outcome will be during pregnancy and up to 6 weeks post partum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The pre-defined secondary endpoints include: 1. Pregnancy loss 10th week of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus 3. Premature birth of a morphologically normal neonate < 34 weeks due to any of: pre-eclampsia, eclampsia, recognized features of placental insufficiency. 4. Gestational age at delivery 5. Birth weight 6. Delivery by Caesarean section 7. Apgar score < 7 at 5 min 8. Neonatal morbidity (bleeding or thrombotic complications, infections, congenital abnormalities) 9. Days to hospital discharge following delivery (mother & child) 10. Thrombotic events in the mother during pregnancy and 6 weeks post-partum. 11. Days of neonate in special care 12. Safety and tolerability of hydroxychloroquine in the mother and in the neonate;Timepoint(s) of evaluation of this end point: The secondary outcome consists of all composite endpoints variables in addition to further post partum complications. Therefore, timepoints of evaluation of the secondary outcome will be during pregnancy and up to 6 weeks post partum. | — |
Countries
Canada, Denmark, United Kingdom
Contacts
Public ContactProf Søren Jacobsen
Rigshospitalet
Outcome results
None listed