Table 2.
Clinical criteria | Laboratory criteria |
---|---|
Vascular thrombosis (1 or more)a: Arterial thrombosis Venous thrombosis Small vessel thrombosis |
Lupus anticoagulant (LA) present in plasma, on 2 or more occasions at least 12 weeks apart. Anticardiolipin (aCL) antibody of IgG and/or IgM in serum or plasma, present in medium or high titer on 2 or more occasions at least 12 weeks apart. Anti-b2 glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma in titer >99th centile, present in 2 or more occasions at least 12 weeks apart Investigators are strongly advised to classify APS patients in studies into one of the following categories: I: more than one laboratory criteria present (any combination) IIa: LA present alone IIb: aCL antibody present alone IIc: anti-b2 glycoprotein-I antibody present alone. |
Obstetric complications: 1 or more unexplained deaths of a morphological normal fetus at or beyond 10 weeks gestation 1 or more premature births of morphological normal fetus (<34 weeks) because of: Eclampsia or sever preeclampsia Placental insufficiencyb 3 or more unexplained consecutive spontaneous abortions before 10 weeks, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded. |
A thrombotic episode in the past could be considered a clinical criterion if thrombosis is proved by appropriate diagnostic means and that no alternative diagnosis or cause of thrombosis is found. Superficial venous thrombosis is not included in the clinical criteria.
Placental insufficiency includes (i) abnormal or non-reassuring fetal surveillance test(s), (ii) abnormal Doppler flow velocimetry waveform analysis suggestive of fetal hypoxemia, (iii) oligohydramnios, (iv) a postnatal birth weight less than the 10th percentile for the gestational age. Adapted from Miyakis et al. (32).