Fouda 2011.

Study characteristics
Methods	2‐arm, prospective, open‐labelled, multicentre, randomised controlled trial (N = 60)
Participants	Inclusion criteria 1) ≥ 3 consecutive pregnancy losses before 10 weeks' gestation 2) Positive anticardiolipin antibodies IgG (> 40 GPL) and IgM (> 40 MPL) or presence of LAC (aPTT and dilute Russell viper venom test). All of the women with positive LAC and/or anticardiolipin antibodies were retested after at least 12 weeks. Only those with persistently positive tests were included in the study. Exclusion criteria Paternal chromosomal abnormalities; uterine malformation detected by hysterosalpingography or office hysteroscopy; cervical incompetence; luteal‐phase defect; abnormal thyroid function tests; hyperprolactinaemia; polycystic ovary syndrome; hereditary thrombophilia; systemic lupus erythematosus; previous venous or arterial thrombotic episodes; diabetes mellitus; kidney or liver disease; gastric ulcer; and sensitivity to aspirin, UFH, or enoxaparin.
Interventions	Unfractionated heparin 5000 U sc twice daily + aspirin 75 mg/day (N = 30) versus LMWH (enoxaparin) 40 mg/day sc + aspirin 75 mg/day (N = 30)
Outcomes	Primary outcome Live birth rate Secondary outcomes Excessive haemorrhage (defined by a 10% decline in the hematocrit value or the requirement of a blood transfusion), thrombocytopenia (platelet count b100,000/mL), IUGR (birthweight lower than the tenth percentile for gestational age), pre‐eclampsia (blood pressure ≥140/90 mm Hg and proteinuria ≥ 300 mg/day), IUFD, and spontaneous osteoporotic fractures. For the infants, the secondary endpoints were preterm labour (birth of infant at < 37 weeks of gestation), neonatal bleeding, and congenital anomalies.
Notes	Multicentre trial (2 centres). All women became pregnant after randomisation. Aspirin was started before conception and continued through pregnancy until 36 weeks of gestation. Anticoagulation treatment was started as soon as the serum pregnancy test became positive. Mean number of previous pregnancy losses was 4.37 ± 1.19 in the UFH + aspirin group versus 4.23 ± 1.16 in the LMWH + aspirin group; no specification for previous early and late loss reported. 10/30 pregnancy losses in the UFH + aspirin group (9/30 first trimester loss, 1/30 second trimester loss) versus 6/30 pregnancy losses in the LMWH + aspirin group (6/30 first trimester loss, 0/30 second trimester loss). No intrauterine fetal death in either group. Trial registry: the study was registered at clinicaltrials.gov [NCT01051778]. Dates of study: recruitment period 28 June 2006 to 14 December 2009, publication 2011. 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 randomisation list.
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered, opaque sealed envelopes, each containing the allocation information written on a card. The envelopes were opened sequentially by a staff nurse to assign the women to either treatment group. The computer‐generated randomisation list and the sealed envelopes were prepared by a statistician not involved in the study.
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)	Low risk	The study was registered at clinicaltrials.gov [NCT01051778]. All of the study's pre‐specified outcomes and all expected outcomes of interest were reported.
Other bias	Low risk	Multicentre trial (2 centres).