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Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT (HepASA)

This study has been terminated.
(interim analysis found no difference in LB rate and lower than expected event rate)
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00564174
First received: November 26, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 26, 2007
November 26, 2007
March 2000
Not Provided
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 ]
Same as current
No Changes Posted
Secondary outcomes included adverse events and incidence of bone loss in the two groups. [ Time Frame: pre-pregnancy through postpartum period ]
Same as current
Not Provided
Not Provided
 
Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Pregnancy Loss
  • Antiphospholipid Antibody Syndrome
  • Drug: Low molecular weight heparin and low dose aspirin
    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
    Other Names:
    • Fragmin (Dalteparin Sodium)
    • ASA
  • Drug: Low dose aspirin
    81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
    Other Name: ASA
  • Experimental: a
    Intervention: Drug: Low molecular weight heparin and low dose aspirin
  • Active Comparator: b
    Low dose aspirin only
    Intervention: Drug: Low dose aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
September 2005
Not Provided

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
Female
18 Years to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00564174
33762, CIHR 37749
Yes
Not Provided
Mount Sinai Hospital, Canada
  • Canadian Institutes of Health Research (CIHR)
  • Pfizer
Principal Investigator: Carl A Laskin, MD Associate Professor, Department of Medicine, University of Toronto
Mount Sinai Hospital, Canada
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP