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

Not Applicable

Terminated

• Conditions: Recurrent Pregnancy Loss; Antiphospholipid Antibody Syndrome
• Interventions: Drug: Low molecular weight heparin and low dose aspirin; Drug: Low dose aspirin

• Registration Number: NCT00564174
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Study Timeline

• Study Start: 2000-03
• Study Completion: 2005-09
• Status Verified: 2007-11
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Last Update Submitted: 2007-11-26
• Study First Posted: 2007-11-27
• Last Update Posted: 2007-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a	Low molecular weight heparin and low dose aspirin	-
b	Low dose aspirin	Low dose aspirin only

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Mount Sinai Hosptial; 🇨🇦 Toronto, Ontario, Canada

McMaster Medical Centre; 🇨🇦 Hamilton, Ontario, Canada