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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
McMaster Medical Centre
Hamilton, Ontario, Canada
Mount Sinai Hosptial
Toronto, Ontario, Canada
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
Time frame: Duration of pregnancy
Secondary outcomes included adverse events and incidence of bone loss in the two groups.
Time frame: pre-pregnancy through postpartum period
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