Branch 2000.

Methods	Multicentre, double‐blind, placebo controlled RCT.
Participants	Inclusion criteria: 1) A single live fetus of </= 12 weeks' gestation. 2) Either IgG ACL >/= 20 GPL units and a history of fetal death and/or venous/arterial thromboembolism or IgG ACL >/=40 GPL units or LA, but no history of fetal death or thromboembolism. Exclusion criteria: 1) Thrombocytopenia. 2) Bleeding disorder. 3) Osteoporosis. 4) Allergy to IVIG or heparin or aspirin. 5) Active renal disease, SLE, insulin dependant diabetes mellitus or hypertension.
Interventions	Intravenous immunoglobulin (10%) 1 g/kg versus placebo (albumin 5%), on 2 days every 4 weeks. All participants also received aspirin 81 mg/day and heparin 7500 units twice daily sc.
Outcomes	Multiple obstetric and neonatal outcomes.
Notes	1/16 subjects had no prior fetal loss. Randomisation and treatment commenced once a single live conceptus </= 12 weeks identified. Gestational age in IVIG and placebo groups respectively for: randomisation 9, 9.7 weeks; start of aspirin 5.5, 4.2 weeks; start of heparin 5.1, 5.5 weeks; start of IVIG/placebo 11, 11.3 weeks.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate