Clinical Trial: Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Mount Sinai Hospital, Canada

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcomes included adverse events and incidence of bone loss in the two groups. [ Time Frame: pre-pregnancy through postpartum period ]

Original Secondary Outcome: Same as current

Information By: Mount Sinai Hospital, Canada

Dates:
Date Received: November 26, 2007
Date Started: March 2000
Date Completion:
Last Updated: November 26, 2007
Last Verified: November 2007