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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564174

Acronym

HepASA

Enrollment

Registered

2007-11-27

Start date

2000-03-31

Completion date

2005-09-30

Last updated

2007-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Antibody Syndrome, Recurrent Pregnancy Loss

Keywords

recurrent pregnancy loss, lupus anticoagulant, anti cardiolipin antibodies, thrombophilia, low molecular weight heparin, aspirin, randomized clinical trial

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.

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.

Interventions

DRUGLow 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

DRUGLow dose aspirin

81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

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

Design outcomes

Primary

Measure	Time frame
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.	Duration of pregnancy

Secondary

Measure	Time frame
Secondary outcomes included adverse events and incidence of bone loss in the two groups.	pre-pregnancy through postpartum period

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026