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

Information source: Mount Sinai Hospital, Canada
ClinicalTrials.gov processed this data on August 20, 2015
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


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Female.


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:


- known peptic ulcer disease

- sensitivity to ASA or heparin

- previous thrombotic event

- geographic distance from clinic

- failure to consent

Locations and Contacts

McMaster Medical Centre, Hamilton, Ontario, Canada

Mount Sinai Hosptial, Toronto, Ontario M5G 1X5, Canada

Additional Information

Starting date: March 2000
Last updated: November 26, 2007

Page last updated: August 20, 2015

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