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

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ClinicalTrials.gov Identifier: NCT00564174
Recruitment Status : Terminated (interim analysis found no difference in LB rate and lower than expected event rate)
First Posted : November 27, 2007
Last Update Posted : November 27, 2007
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by:
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Recurrent Pregnancy Loss Antiphospholipid Antibody Syndrome Drug: Low molecular weight heparin and low dose aspirin Drug: Low dose aspirin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
Study Start Date : March 2000
Actual Study Completion Date : September 2005


Arm Intervention/treatment
Experimental: a 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
Active Comparator: b
Low dose aspirin only
Drug: Low dose aspirin
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
Other Name: ASA



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564174


Locations
Canada, Ontario
McMaster Medical Centre
Hamilton, Ontario, Canada
Mount Sinai Hosptial
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR)
Pfizer
Investigators
Principal Investigator: Carl A Laskin, MD Associate Professor, Department of Medicine, University of Toronto

ClinicalTrials.gov Identifier: NCT00564174     History of Changes
Other Study ID Numbers: 33762
CIHR 37749
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by Mount Sinai Hospital, Canada:
recurrent pregnancy loss
lupus anticoagulant
anti cardiolipin antibodies
thrombophilia
low molecular weight heparin
aspirin
randomized clinical trial

Additional relevant MeSH terms:
Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Antiphospholipid Syndrome
Pregnancy Complications
Death
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants