Alalaf 2012.

Study characteristics
Methods	Open‐label, randomised controlled trial (N = 141)
Participants	Inclusion criteria 1) age 18‐42 years at time of interview 2) ≥ 2 unexplained consecutive miscarriages before 20 weeks' gestation 3) persistent presence of aCL antibodies (IgG > 15 GPL or IgM > 25 MPL) or positive LAC on 2 occasions, 8 weeks apart. Exclusion criteria Systemic lupus erythematosus, known peptic ulcer disease, sensitivity to aspirin or heparin depending on patient's history report, previous venous thromboembolic disease requiring ongoing anticoagulant therapy, other causes for recurrent miscarriage (polycystic ovarian syndrome, thyroid dysfunction, anatomical causes), bacterial vaginosis infection and failure to consent to participate.
Interventions	LMWH (bemiparin) 2500 IU/day sc (N = 80) versus Aspirin 100 mg/day (N = 61)
Outcomes	Primary outcome Live birth Secondary outcomes Obstetrical complications, fetal and maternal adverse events
Notes	Aspirin commenced preconceptionally until 36 weeks of gestation, bemiparin commenced when pregnancy was confirmed until 36 weeks of gestation. Mean number of previous pregnancy losses was 3.28 ± 1.72 in the LMWH group versus 3.41 ± 1.76 in the aspirin group; no specification for previous early and late loss reported. As study outcome total pregnancy loss reported; no specification for early and late loss reported. Trial registry: trial not registered in clinical trial registry. No published study protocol. Dates of study: recruitment period 15 September 2007 to 1 August 2010, publication 2012. Funding sources: not stated Declarations of interest: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Process of randomisation not clearly described. Authors state some form of alternation between treatment groups: the first case was randomised to treatment 1, the second case to treatment 2 and sometimes 2 cases were randomised to treatment 1, followed by one case of treatment 2.
Allocation concealment (selection bias)	High risk	Not reported.
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.
Incomplete outcome data (attrition bias) All outcomes	High risk	Exclusions, reasons for exclusion and numbers included in the analysis at each stage were not reported. Loss‐to‐follow up not reported.
Selective reporting (reporting bias)	Unclear risk	Trial not registered in clinical trial registry. No published study protocol.
Other bias	Low risk	No indication of other sources of bias