Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT - Full Text View

Sponsor:	Mount Sinai Hospital, Canada
Collaborators:	Canadian Institutes of Health Research (CIHR) Pfizer
Information provided by:	Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:	NCT00564174

Purpose

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	Intervention
Recurrent Pregnancy Loss Antiphospholipid Antibody Syndrome	Drug: Low molecular weight heparin and low dose aspirin Drug: Low dose aspirin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: factor V Leiden thrombophilia prothrombin thrombophilia

MedlinePlus related topics: Blood Thinners

Drug Information available for: Acetylsalicylic acid Heparin

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:

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:

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

Enrollment:	88
Study Start Date:	March 2000
Study Completion Date:	September 2005

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years to 44 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00564174 History of Changes
Other Study ID Numbers:	33762, CIHR 37749
Study First Received:	November 26, 2007
Last Updated:	November 26, 2007
Health Authority:	Canada: Canadian Institutes of Health Research

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:

Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Aspirin
Heparin
Calcium heparin
Dalteparin
Heparin, Low-Molecular-Weight
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anticoagulants

ClinicalTrials.gov processed this record on February 12, 2012