Obstetric antiphospholipid syndrome
Conditions
Interventions
All subjects will undergo a 7 day treatment course of oral vancomycin, 500mg 4 times daily, a standard antibiotic.
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Obstetric APS diagnosed by Sydney criteria: 1. A history of one or more of the following forms of pregnancy morbidity (a) One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetal morphology documented by ultrasound or by direct examination of the fetus, or (b) One or more premature births of a morphologically normal neonate before the 34th week of gestation because of: (i) eclampsia or severe pre-eclampsia defined according to standard definitions, or (ii) recognized features of placental insufficiency–,or (c) Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded. 2. A history of one or more of the following laboratory criteria a Lupus anticoagulant (LA) present in plasma, on two or more occasions at least 12 weeks apart, detected according to the guidelines of the International Society on Thrombosis and Haemostasis (Scientific Subcommittee on LAs/phospholipid-dependent antibodies). b. Anticardiolipin (aCL) antibody of IgG and/or IgM isotype in serum or plasma, present in medium or high titer (i.e. >40 GPL or MPL, or >the 99th percentile), on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA. c. Anti-b2glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer >the 99th percentile), present on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA, according to recommended procedures.
Exclusion criteria
Exclusion criteria: - Age below 18 years - Current use of antibiotics - History of gastro-enteritis in the past month - History of inflammatory bowel disease - Planned change in the following medication during the study period (either start, stop or dose change): platelet aggregation inhibitors, oral anticoagulants, heparins, hormonal therapy. - Current pregnancy or pregnancy in the past 6 weeks - Arterial or venous thrombosis in the past month - Allergy to vancomycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the composite of a broad panel of APS pathophysiology-related blood biomarkers. These biomarkers are regarded to collectively reflect the oAPS phenotype. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut permeability measured by lactulose/mannitol test. Reduction in antiphospholipid antibodiy titers Subgroup analysis of severe phenotype patients, based on clinical manifestations and antibody profiles | — |
Contacts
Public ContactValérie Jansen
Amsterdam UMC - AMC
Outcome results
None listed