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. 2005 Apr 20;2005(2):CD002859. doi: 10.1002/14651858.CD002859.pub2

Laskin 1997.

Methods Single centre, fully blinded, placebo controlled RCT.
Participants Inclusion criteria: 
 1) Age 18‐39 years. 
 2) >/= 2 consecutive fetal losses < 32 weeks' gestation. 
 3) +ve antibody on at least 2 occasions including at least one of the following: antinuclear, antiDNA (single or double stranded), antilymphocyte IgM, or IgG ACL (> 15 GPL units) antibodies, or LA (APTT, dRVVT, KCT or tissue thromboplastin‐inhibition time). 
 Exclusion criteria: 
 1) Chromosomal abnormality. 
 2) Anatomical abnormality. 
 3) Luteal phase defect (determined by a timed endometrial biopsy). 
 4) Previously untreated tuberculosis. 
 5) Previous prednisone therapy. 
 6) Confirmed peptic ulcer disease within the past three years. 
 7) SLE fulfilling 4 or more of the American College of Rheumatologists criteria. 
 8) Diabetes, aspirin sensitivity, or diastolic BP > 90 on at least 2 occasions.
Interventions Prednisone 0.8 mg/kg (maximum 60 mg) for the first four weeks and then 0.5 mg/kg (maximum 40 mg) plus aspirin 100 mg/day versus placebo.
Outcomes Live infant, maternal side‐effects, infant birthweight, Apgar score and admission to neonatal ICU.
Notes 44% of all subjects in the study had APL antibodies.
Randomisation and drug treatment commenced after a confirmed pregnancy test (confirmation via a rise in BHCG or ultrasound demonstration of fetal heart beat and appropriate fetal size).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate