Fouda 2010.

Study characteristics
Methods	2‐arm prospective, randomised controlled study (N = 60)
Participants	Inclusion criteria 1) ≥ 3 consecutive pregnancy losses before 10 weeks' gestation 2) positive LAC and/or aCL antibodies (IgG and IgM) on at least 2 occasions, at least 12 weeks apart Exclusion criteria Paternal chromosomal abnormalities or uterine abnormalities, luteal phase defect, abnormal thyroid function tests, hyperprolactinaemia, polycystic ovary syndrome, systemic lupus erythematosus, previous thromboembolism, peptic ulcer, age < 19 years or > 37 years, BMI < 19 or > 30 or sensitivity to aspirin or heparin.
Interventions	LMWH (enoxaparin) 40 mg/day sc + aspirin 75 mg/day (N = 30) versus LMWH (enoxaparin) 20 mg/day sc + aspirin 75 mg/day (N = 30)
Outcomes	Primary outcome Live birth rate Secondary outcome Maternal and obstetric complications during pregnancy or puerperium such as excessive bleeding, thrombocytopenia, intrauterine growth restriction, pre‐eclampsia, intrauterine fetal death, thrombotic event and spontaneous osteoporotic fractures. For the infants preterm delivery, neonatal bleeding and congenital anomalies.
Notes	All participants were started on aspirin preconceptionally until 36 weeks and LMWH was added with a confirmed positive pregnancy test and continued until delivery. Mean number of previous pregnancy losses was 4.03 ± 1.24 in the LMWH 40 mg + aspirin group versus 4.1 ± 1.12 in the LMWH 20 mg plus aspirin group; no specification for previous early and late loss reported. 7/30 pregnancy losses in the LMWH 40 mg + aspirin group (6/30 first trimester loss, 1/30 second trimester loss) versus 9/30 pregnancy losses in the LMWH 20 mg + aspirin group (8/30 first trimester loss, 1/30 second trimester loss). No intrauterine fetal death in either group. Trial registry: trial not registered in clinical trial registry. No published study protocol. Dates of study: recruitment period December 2008 to May 2010, publication 2010. Funding sources: not stated Declarations of interest: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers.
Allocation concealment (selection bias)	Low risk	Opaque envelopes.
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	Blinding not reported, but knowledge of treatment allocation unlikely to influence outcome live birth.
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 loss to follow‐up, all participants analysed.
Selective reporting (reporting bias)	Unclear risk	Trial not registered in clinical trial registry. No published study protocol.
Other bias	Low risk	Nothing to indicate any other sources of bias.