Kutteh 1996a.
Methods | Single centre, quasi‐randomised (alternatively 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 alternative treatment assignment. 5) +ve APL antibody on at least 2 occasions determined by IgG ACL or antiphosphotidylserine > 27 GPL units or IgM ACL or antiphosphotidylserine > 23 MPL units. Exclusion criteria: 1) SLE. 2) Positive LA. 3) Presence of another abnormal test result. 4) Aspirin allergy. 5) Other reason for anticoagulation. 6) Refused treatment or allocation. | |
Interventions | Heparin 5000 units twice daily sc plus aspirin 81 mg/day versus aspirin 81 mg/day. Heparin dose increased by 1000 units/dose weekly until PTT 1.2 ‐ 1.5 times baseline. |
|
Outcomes | Multiple obstetric and neonatal outcomes. | |
Notes | Aspirin commenced before conception. Heparin commenced at the first confirmed pregnancy test (5.3 weeks postgestation). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |