Pattison 2000.
Methods | Single centre, fully blinded, placebo controlled RCT. | |
Participants | Inclusion criteria: 1) >/= 3 miscarriages. 2) +ve APL antibody either pre‐pregnancy or early in pregnancy determined by a IgG ACL > 5 GPL units or IgM ACL > 5 MPL units or presence of LA (APTT, dRVVT or KCT). Exclusion criteria: 1) History of thrombosis. 2) SLE. 3) Current or planned corticosteroids, NSAIDs, heparin or marine lipids. | |
Interventions | Aspirin 75 mg/day versus placebo. | |
Outcomes | Live birth, antenatal outcomes and neonatal outcomes. | |
Notes | 20% subjects excluded from each treatment arm on the basis of ineligibility. Randomisation occured when pregnancy diagnosed if APL antibodies +ve before pregnancy or when detected during pregnancy. Aspirin/placebo commenced 50/44 days respectively after last menstrual period. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |