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

NCT00564174

Last updated date
Study Location
McMaster Medical Centre
Hamilton, Ontario, , Canada
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Recurrent Pregnancy Loss, Antiphospholipid Antibody Syndrome
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-44 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- SLE


- known peptic ulcer disease


- sensitivity to ASA or heparin


- previous thrombotic event


- geographic distance from clinic


- failure to consent

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Recurrent Pregnancy Loss, Antiphospholipid Antibody SyndromeLow Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
NCT00564174
  1. Hamilton, Ontario
  2. Toronto, Ontario
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
Official Title  ICMJE A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Pregnancy Loss
  • Antiphospholipid Antibody Syndrome
Intervention  ICMJE
  • 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:
    • Fragmin (Dalteparin Sodium)
    • ASA
  • Drug: Low dose aspirin
    81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
    Other Name: ASA
Study Arms  ICMJE
  • Experimental: a
    Intervention: Drug: Low molecular weight heparin and low dose aspirin
  • Active Comparator: b
    Low dose aspirin only
    Intervention: Drug: Low dose aspirin
Publications * Hamulyák 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:CD012852. doi: 10.1002/14651858.CD012852.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 26, 2007)
88
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00564174
Other Study ID Numbers  ICMJE 33762
CIHR 37749
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mount Sinai Hospital, Canada
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Carl A Laskin, MDAssociate Professor, Department of Medicine, University of Toronto
PRS Account Mount Sinai Hospital, Canada
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP