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. 2005 Apr 20;2005(2):CD002859. doi: 10.1002/14651858.CD002859.pub2

Kutteh 1996b.

Methods Single centre, quasi‐randomised (sequentially assigned to treatment) non‐blinded, non‐placebo controlled.
Participants Inclusion criteria: 
 1) Desire to become pregnant. 
 2) Agreement to be completely evaluated. 
 3) >/= 3 consecutive pregnancy losses. 
 4) Consent to treatment protocol. 
 5) +ve APL antibody on at least 2 occasions determined by IgG > 27 GPL units (> 2.5 multiples of the median). 
 Exclusion criteria: 
 1) SLE. 
 2) Positive LA. 
 3) Presence of another abnormal test result. 
 4) Aspirin allergy. 
 5) Documented bone disorder. 
 6) Refused treatment.
Interventions Heparin 5000 units twice daily sc adjusted to maintain the PTT at 1.2 to 1.5 times the baseline (high‐dose) plus aspirin 81 mg/day versus heparin 5000 units twice daily adjusted to maintain the PTT at the upper limit of normal (low‐dose) plus aspirin 81 mg/day.
Mean daily dose: high dose 13,300 units BD; low dose 8127 units BD.
Outcomes Multiple obstetric and neonatal outcomes.
Notes Aspirin commenced before conception. 
 Heparin commenced at the first confirmed pregnancy test (5.3 and 5.2 weeks postgestation for high dose and low dose respectively).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? High risk C ‐ Inadequate