Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
Information source: Mount Sinai Hospital, Canada
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Pregnancy Loss; Antiphospholipid Antibody Syndrome
Intervention: Low molecular weight heparin and low dose aspirin (Drug); Low dose aspirin (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Mount Sinai Hospital, Canada Official(s) and/or principal investigator(s):
Carl A Laskin, MD, Principal Investigator, Affiliation: Associate Professor, Department of Medicine, University of Toronto
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.
Clinical Details
Official title: A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
Secondary outcome: Secondary outcomes included adverse events and incidence of bone loss in the two groups.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 44 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Mount Sinai Hosptial, Toronto, Ontario M5G 1X5, Canada
McMaster Medical Centre, Hamilton, Ontario, Canada
Additional Information
Starting date: March 2000
Ending date: September 2005
Last updated: November 26, 2007
|
