Farquharson 2002.

Study characteristics
Methods	Single‐centre, randomised non‐blinded, non‐placebo controlled trial (N = 98)
Participants	Inclusion criteria 1) 18‐41 years 2) ≥ 3 consecutive pregnancy losses or 2 consecutive losses with proven fetal death after 10 weeks 3) 2 positive test for antiphospholipid antibodies more than 6 weeks apart, determined by lupus anticoagulant (dRVVT > 1.09 with > 20% correction with platelets), or aCL antibodies (IgG > 9 U/mL or aCL IgM > 5 U/mL) Exclusion criteria Parental chromosomal abnormality, uterine anomaly, previous arterial of venous thrombosis, use of steroids during pregnancy, systemic lupus erythematosus requiring medication or complicated by nephritis, and other thrombophilia such as activated protein C resistance or protein C/S deficiency.
Interventions	LMWH 5000 IU/day sc + aspirin 75 mg/day (N = 51) versus Aspirin 75 mg/day (N = 47)
Outcomes	Embryo loss (no visible crown rump length or fetal heart activity) and fetal loss (loss of fetal heart activity after clear identification on previous scan)
Notes	Randomisation occurred < 12 weeks' gestation, mean 7.1 weeks for LMWH plus aspirin group and 6.3 weeks for the aspirin group Mean number of previous pregnancy losses was 3 ± 0.8 in the LMWH + aspirin group versus 3 ± 0.9 in the aspirin group; no specification for previous early and late loss reported. LMWH plus aspirin or aspirin started at randomisation (before 12 weeks of gestation) and continued until delivery. 11/47 in the aspirin group also took LMWH and 13/51 in the aspirin/LMWH group took aspirin alone Type of LMWH not specified. 11/51 pregnancy losses in the LMWH plus aspirin group (3/11 embryo loss, 8/11 fetal loss) versus 13/47 pregnancy losses in the aspirin group (9/13 embryo loss, 4/13 fetal loss). 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 period from January 1997 to January 2000, publication in 2002. Funding sources: LUPUS UK and NHS R&D (NWEST) grant support Declarations of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence of random numbers.
Allocation concealment (selection bias)	Low risk	Telephone randomisation, adequate allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding, but knowledge of treatment allocation unlikely to influence outcome live birth
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No blinding, but knowledge of treatment allocation unlikely to influence outcome live birth Data collection by independent research officer who received copies of randomisation data sheets. Blinding of outcome assessment not explicitly stated.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Exclusions, reasons for exclusion and numbers included in the analysis at each stage were reported; no missing outcome data, no loss to follow‐up.
Selective reporting (reporting bias)	Unclear risk	All analyses completed on an intention‐to‐treat basis. 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 other sources of bias