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

Recurrent Pregnancy Loss Clinical Trial

— HepASA  

Official title:

A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00564174
• Other study ID #: 33762
• Secondary ID: CIHR 37749
• Status: Terminated
• Phase: N/A
• First received: November 26, 2007
• Last updated: November 26, 2007
• Start date: March 2000
• Est. completion date: September 2005

Study information

• Verified date: November 2007
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Antiphospholipid Antibody Syndrome
• Antiphospholipid Syndrome
• Fetal Death
• Recurrent Pregnancy Loss

Intervention

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
• Low dose aspirin
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Locations

Country	Name	City	State
Canada	McMaster Medical Centre	Hamilton	Ontario
Canada	Mount Sinai Hosptial	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR), Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

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