| Methods |
Single centre, non‐blinded, non‐placebo controlled RCT. |
| Participants |
Inclusion criteria:
1) >/= 3 consecutive miscarriages.
2) +ve APL antibody on at least 2 occasions > 8 weeks apart determined by ACL IgG > 5 GPL units or ACL IGM > 3 MPL units or a positive LA (APTT, dRVVT ratio>/= 1.1 confirmed by platelet neutralisation ‐ decrease of >/= 10% of ratio).
Exclusion criteria:
1) Previous thromboembolism.
2) SLE.
3) Uterine abnormality on ultrasound.
4) Hypersecretion of luteinising hormone.
5) Multiple pregnancy.
6) Abnormal karyotype of either partner. |
| Interventions |
Calcium heparin 5000 units twice daily sc plus aspirin 75 mg/day versus aspirin 75 mg/day alone. |
| Outcomes |
Live birth, gestational age and weight, congenital abnormality, admission to neonatal ICU, bone mineral densitometry and maternal morbidity. |
| Notes |
Aspirin commenced in all when +ve pregnancy test.
Randomisation occurred when fetal heart activity noted on ultrasound (6.6 weeks in aspirin group and 6.7 weeks in aspirin/heparin group). Heparin commenced in heparin only group after randomisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
