Recurrent Pregnancy Loss Clinical Trial
— HepASAOfficial title:
A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
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.
Status | Terminated |
Enrollment | 88 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Medical Centre | Hamilton | Ontario |
Canada | Mount Sinai Hosptial | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada | Canadian Institutes of Health Research (CIHR), Pfizer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. | Duration of pregnancy | ||
Secondary | Secondary outcomes included adverse events and incidence of bone loss in the two groups. | pre-pregnancy through postpartum period |
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