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). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |