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

Tracking Information

First Received Date ^ICMJE

November 26, 2007

Last Updated Date

November 26, 2007

Start Date ^ICMJE

March 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Recurrent Pregnancy Loss
Antiphospholipid Antibody Syndrome

Intervention ^ICMJE

Drug: Low molecular weight heparin and low dose aspirin
Drug: Low dose aspirin

Study Arms / Comparison Groups

Active Comparator: Low dose aspirin only

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

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

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00564174

Responsible Party

Study ID Numbers ^ICMJE

33762, CIHR 37749

Study Sponsor ^ICMJE

Mount Sinai Hospital, Canada

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)
Pfizer

Investigators ^ICMJE

Principal Investigator:

Carl A Laskin, MD

Associate Professor, Department of Medicine, University of Toronto

Information Provided By

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