Inclusion Criteria

INCLUSION CRITERIA
Clinical criteria:

1- Women that fulfill only pregnancy morbidity complications included in the APS Sydney criteria with no history of previous documented thromboses, at least five years to entry in this study before.

(b) Women with no previous thrombotic events that presented history of one or more unexplained deaths of a morphologically foetus at or beyond the 10th week of gestation, with normal foetal morphology documented by ultrasound or by direct examination of the foetus.

(c) Women with no previous thrombotic events presented with one o more premature births of a morphologically normal neonate before the 34th week of gestation because of: (i) eclampsia or severe preeclampsia defined according to SD, or (ii) recognized features of placental insufficiency (abnormal or non-reassuring fetal surveillance test(s), e.g. a non-reactive non-stress test, (ii) abnormal Doppler flow velocimetry waveform analysis suggestive of fetal hypoxemia, e.g. absent end-diastolic flow in the umbilical artery, (iii) oligohydramnios fluid index of 5 cm or less, or (iv) a postnatal birth weight less than the 10 percentile for the gestational age.

(d) Women with no previous thrombotic events and history of 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- Women that fulfill pregnancy morbidity complications not included in the APS Sydney criteria, with no history of previous clearly documented thromboses, at least five years to entry in this study before.

(a) Women with no previous thrombotic events and history of two 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.

(b) Women with no previous thrombotic events and history of two or more unexplained in vitro fertilization failures.

(c) Women suffering from subchorionic haematoma / abruption placenta.


Laboratory criteria:

1. Standard laboratory criteria according to Sydney recommendations:

(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.

(b) Anticardiolipin (aCL) antibody of IgG and/or IgM isotype in serum or plasma, present in medium or high titer, or > the 99th percentile, on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA.

(c) Anti--β2glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer > the 99 percentile), present on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA, according to recommended procedures.

2. Non-standard laboratory markers:

(a) Anti-annexin A5 antibodies (aANXA5) (IgG/IgM) or anti-phosphatydilserine IgG/IgM antibodies (aPS) or antiPS/anti-Prothrombin IgG/IgM antibodies (aPS/aPt) in serum or plasma(in titer > the 99 percentile), present on two o more occasions, at least 12 weeks apart, measured by a standardized commercial ELISA methods.

(b) Repeated False-Positive Serologic Test for Syphilis (RFP-TS): repeated positive values in plasma of either treponemal (FTA-ABS or MHA-TP) and/or non-treponemal (RPR or VDRL), (IgG/IgM) test.

3. Non-standard interval time

(a). Lupus anticoagulant and/or anticardiolipin antibody of IgG and/or IgM isotype and/or anti-β2glycoprotein-I antibody of IgG and/or IgM isotype, detected on two more occasions less than 12 weeks apart, measured by a standardized methods.

(b). Anti-annexin A5 antibodies of IgG and/or /IgM or anti-phosphatydilserine of IgGand/or IgM antibodies or antiPS/anti-Prothrombin of IgGand/or IgM antibodies in serum or plasma, present on two o more occasions, less than 12 weeks apart, measured by a standardized commercial ELISA methods.

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