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

Mount Sinai Hospital, Canada

Status: Terminated

Conditions: Recurrent Pregnancy Loss; Antiphospholipid Antibody Syndrome

Treatments: Drug: Low molecular weight heparin and low dose aspirin; Drug: Low dose aspirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00564174

33762

CIHR 37749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

a

Experimental group

Treatment:

Drug: Low molecular weight heparin and low dose aspirin

b

Active Comparator group

Description:

Low dose aspirin only

Treatment:

Drug: Low dose aspirin