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Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity

NCT04153760 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2023-09-13

No results posted yet for this study

Summary

The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.

Conditions

  • Venous Thromboembolism
  • Postpartum Period
  • Aspirin

Interventions

DRUG

Aspirin 81 mg

Aspirin 81 mg p.o. daily

DRUG

Placebo

Placebo p.o. daily

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

    collaborator NETWORK

  • University of Calgary

    lead OTHER

Principal Investigators

  • Leslie Skeith, MD · University of Calgary

  • Marc Rodger, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2023-09-05
Completion
2023-09-05

Countries

  • Canada
  • France
  • Ireland
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153760 on ClinicalTrials.gov