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

NCT00564174 | Terminated DMC

• 2 other identifiers: 33762CIHR 37749
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Pregnancy Loss; Antiphospholipid Antibody Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes included adverse events and incidence of bone loss in the two groups.

  pre-pregnancy through postpartum period

Study Arms (2)

a

EXPERIMENTAL

Drug: Low molecular weight heparin and low dose aspirin

b

ACTIVE COMPARATOR

Low dose aspirin only

Drug: Low dose aspirin

Interventions

Low molecular weight heparin and low dose aspirin 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

Also known as: Fragmin (Dalteparin Sodium), ASA

a

Low dose aspirin DRUG

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

Also known as: ASA

b

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• SLE
• known peptic ulcer disease
• sensitivity to ASA or heparin
• previous thrombotic event
• geographic distance from clinic
• failure to consent

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Pfizer: collaborator

Study Sites (2)

McMaster Medical Centre

Hamilton, Ontario, Canada

Location

Mount Sinai Hosptial

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 32358837 DERIVED

MeSH Terms

Conditions

Antiphospholipid Syndrome; Thrombophilia

Interventions

Heparin, Low-Molecular-Weight; Aspirin; Dalteparin

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Carl A Laskin, MD

  Associate Professor, Department of Medicine, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: March 1, 2000
• Study Completion: September 1, 2005
• Last Updated: November 27, 2007

Record last verified: 2007-11

Locations

CA (2)