interim analysis found no difference in LB rate and lower than expected event rate

To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.

Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.

Inclusion Criteria:

• history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
• presence of one of the panel of autoantibodies/thrombophilia markers
• confirmed pregnancy

Exclusion Criteria:

• SLE
• known peptic ulcer disease
• sensitivity to ASA or heparin
• previous thrombotic event
• geographic distance from clinic
• failure to consent