NCT00564174

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Pregnancy Loss
• Antiphospholipid Antibody Syndrome

Interventions

Type	Name	Description
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
DRUG	Low dose aspirin	81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Timeline

• Start date: 2000-03-01
• Completion: 2005-09-01
• First posted: 2007-11-27
• Last updated: 2007-11-27

Locations

2 sites across 1 country: Canada