Pattison 2000.

Study characteristics
Methods	Single‐centre, double‐blind, randomised, placebo‐controlled trial (N = 40)
Participants	Inclusion criteria 1) ≥ 3 miscarriages 2) persistent positive aPL antibody pre‐pregnancy or early during index pregnancy; anticardiolipin antibodies IgG ≥ 5 GPL units or IgM ≥ 5 MPL units or presence of LAC (aPTT, dRVVT or KCT). Exclusion criteria History of thrombosis, systemic lupus erythematosus, current or planned therapy with corticosteroids, NSAIDs, heparin or marine lipids.
Interventions	Aspirin 75 mg/day (N = 20) versus Placebo (N = 20)
Outcomes	Live birth, antenatal outcomes (bleeding, hypertension, preterm birth, caesarean delivery) and neonatal outcomes (birthweight, small‐for‐gestational age, neonatal admission, congenital anomalies)
Notes	Randomisation after confirmation of pregnancy, if antiphospholipid antibodies were positive before pregnancy or detected during pregnancy. Aspirin and placebo commenced 50 and 44 days respectively after last menstrual period, duration of treatment was not defined. Overall percentage of previous pregnancy losses 80.7% in the aspirin group versus 74.8% in the placebo group. Median first‐trimester losses 3 (interquartile range 1.5) in the aspirin group versus 4.5 (3) in the placebo group. As study outcome total pregnancy loss reported; no specification for early and late loss reported. Trial registry: trial not registered in clinical trial registry, but clinical trial registry at time of publication non‐existing. No published study protocol. Dates of study: recruitment over a period of 39 months, no further specification. Publication in 2000. Funding sources: not stated Declarations of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list of study numbers.
Allocation concealment (selection bias)	Low risk	Sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding by placebo.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding by placebo.
Incomplete outcome data (attrition bias) All outcomes	High risk	In each arm 5/25 (20%) of participants were excluded because of inappropriate inclusion. Analyses were performed with and without these participants but results from included participants only published. No analysis by intent‐to‐treat. No loss to follow‐up.
Selective reporting (reporting bias)	Unclear risk	Results from included participants only published. Insufficient data to assess whether all outcomes were reported. Trial not registered in clinical trial registry, but clinical trial registry at time of publication non‐existing. No published study protocol.
Other bias	Low risk	No indication of any other source of bias.