Triolo 2003.
Methods | Single centre, non‐blinded, non‐placebo controlled RCT. | |
Participants | Inclusion criteria: 1) 18‐39 years. 2) >/= 3 consecutive fetal losses < 10 weeks' gestation. 3) >/= 2 +ve results for ACL (intervals >/= 3 months) determined by IgG ACL > 40 GPL units. Exclusion criteria: 1) Chromosomal or anatomical abnormality or luteal phase defect. 2) Confirmed peptic ulcer. 3) SLE. 4) Diabetes mellitus or abnormal glucose tolerance test. 5) Previous thromboembolism. 6) Aspirin sensitivity. 7) Hypertension or current treatment with antihypertensives. 9) Previous prednisone. 10) Abnormal chest X‐ray. 11) Positive tuberculin test. | |
Interventions | IVIG 400 mg/kg/day for 2 consecutive days then single monthly dose versus LMW heparin (Seleparina) 5700 IU/day and aspirin 75 mg/day. | |
Outcomes | Pregnancy loss, maternal side‐effects, preterm delivery (< 37 weeks), neonatal ICU admission, low birthweight and neonatal bleeding or bruising. | |
Notes | 9.5% of the LMW heparin group withdrew because of poor compliance and were excluded from the analysis. All treatment commenced as soon as a +ve pregnancy test. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |