Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity - PARTUM

The University of Calgary0 sites336 target enrollmentApril 30, 2021

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

The University of Calgary

•ONE (or more) First Order Criterion:
•1\. Known inherited thrombophilia diagnosed prior to enrolment. The necessary
•laboratory results must be available to confirm the diagnosis. Women with one of the
•following thrombophilias will be eligible for the trial, regardless of family history of
•i) Heterozygous factor V Leiden (genotyping result required), or
•ii) Heterozygous prothrombin gene variant (genotyping result required), or
•iii) Protein C deficiency (two abnormal and no normal tests based on local laboratory
•cutoffs), or
•iv) Protein S deficiency (two abnormal and no normal tests, one of which is done
•outside of pregnancy/postpartum OR two abnormal tests in

•Women will be excluded from the trial if they have a known increased risk of VTE where
•there is sufficiently high risk and/or adequate evidence to determine that LMWH or ASA
•is indicated, based on their physician and/or local investigator, with examples listed
•The trial exclusion criteria are as listed:
•1\. More than 48 hours since delivery of the placenta at the time of randomization
•2\. Received more than 2 doses of LMWH since delivery of the placenta\*
•3\. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by
•their physician and/or local investigator. May include but is not limited to:
•a. Documented history of provoked or unprovoked VTE
•b. Mechanical heart valve(s)