MedDataX Logo

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

NCT ID: NCT00564174

Last Updated: 2007-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2005-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Pregnancy Loss Antiphospholipid Antibody Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

recurrent pregnancy loss lupus anticoagulant anti cardiolipin antibodies thrombophilia low molecular weight heparin aspirin randomized clinical trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

a

Group Type EXPERIMENTAL

Low molecular weight heparin and low dose aspirin

Intervention Type DRUG

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

b

Low dose aspirin only

Group Type ACTIVE_COMPARATOR

Low dose aspirin

Intervention Type DRUG

81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Low dose aspirin

81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fragmin (Dalteparin Sodium) ASA ASA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carl A Laskin, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Medicine, University of Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McMaster Medical Centre

Hamilton, Ontario, Canada

Site Status

Mount Sinai Hosptial

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.

Reference Type DERIVED
PMID: 32358837 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIHR 37749

Identifier Type: -

Identifier Source: secondary_id

33762

Identifier Type: -

Identifier Source: org_study_id