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

November 26, 2007 updated by: Mount Sinai Hospital, Canada

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster Medical Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a
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
Other Names:
  • ASA
  • Fragmin (Dalteparin Sodium)
Active Comparator: b
Low dose aspirin only
Drug: Low dose aspirin
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
Other Names:
  • ASA

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Duration of pregnancy
Duration of pregnancy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Collaborators

Pfizer
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Carl A Laskin, MD, Associate Professor, Department of Medicine, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33762
  • CIHR 37749

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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