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

NCT00564174 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2007-11-27

No results posted yet for this study

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.

Conditions

  • Recurrent Pregnancy Loss
  • Antiphospholipid Antibody Syndrome

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Pfizer

    collaborator INDUSTRY

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Carl A Laskin, MD · Associate Professor, Department of Medicine, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Completion
2005-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564174 on ClinicalTrials.gov