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. |
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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 |